Clinical trial NCT01492361: A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and on Statin
Official title: Evaluation of the Effect of AMR101 on Cardiovascular Health and Mortality in Hypertriglyceridemic Patients With Cardiovascular Disease or at High Risk for Cardiovascular Disease: REDUCE-IT (Reduction of Cardiovascular Events With EPA - Intervention Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiovascular Diseases
Keywords: Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Acute Coronary Syndrome
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Anticholesteremic Agents
Hypolipidemic Agents
Lipid Regulating Agents
Hypertriglyceridemia
Omega-3 Fatty Acids
Statin
Triglycerides
EPA
Docosahexaenoic Acid
Fish
Fatty acids
Fibrates
Niacin
Lipids
Lipoprotein
Atorvastatin
Lovaza
Simvastatin
Lovastatin
Pravastatin
Fluvastatin
Rosuvastatin
Trilipix
Vytorin
Simcor
Ezetimibe
Zetia
Ethyl-EPA
Ethyl Icosapentate
Crestor
Zocor
Lipitor
LDL
HDL
Cholesterol
Dyslipidemia
AMR101
Cardiovascular Disease, Unspecified
VASCEPA
Icosapent Ethyl
Lead sponsor: Amarin Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2011-12-15
Enrollment: 8179
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: AMR101 (icosapent ethyl \[ethyl-EPA\]) is a highly purified ethyl ester of eicosapentaenoic acid (EPA) developed by Amarin Pharma Inc. for the treatment of cardiovascular disease in statin-treated patients with hypertriglyceridemia. The purpose of this study was to evaluate whether this drug, combined with a statin therapy, will be superior to the statin therapy alone, when used as a prevention in reducing long-term cardiovascular events in high-risk patients with mixed dyslipidemia.


Eligibility criteria: Inclusion Criteria:

* Men and non-pregnant or sterile women ages 45 and older
* Hypertriglyceridemia
* On statin therapy for at least four weeks
* Either having established cardiovascular disease or at high risk for cardiovascular disease

Exclusion Criteria:

* Severe heart failure
* Any life-threatening disease other than cardiovascular disease
* Active severe liver disease
* Hemoglobin A1c \>10.0%
* Poorly controlled hypertension
* Planned coronary intervention (such as stent placement or heart bypass) or any non-cardiac major surgical procedure
* Known familial lipoprotein lipase deficiency (Fredrickson Type I), apolipoprotein C-II deficiency, or familial dysbetalipoproteinemia (Fredrickson Type III)
* Known hypersensitivity to the study product, fish and/or shellfish, or placebo
* History of acute or chronic pancreatitis
* Patients are excluded if using the following medications:

  * PCSK9 inhibitors
  * niacin \>200 mg/day or fibrates;
  * any omega-3 fatty acid medications ;
  * dietary supplements containing omega-3 fatty acids (e.g., flaxseed oil, fish oil, krill oil, or algal oil);
  * bile acid sequestrants

Primary outcomes:
measure: Composite of CV Death, Nonfatal MI (Including Silent MI), Nonfatal Stroke, Coronary Revascularization, or Unstable Angina Determined to be Caused by Myocardial Ischemia by Invasive / Non-invasive Testing and Requiring Emergent Hospitalization.
timeFrame: Total follow-up time of up to approximately 6 years.
Secondary outcomes:
measure: Composite of CV Death, Nonfatal MI (Including Silent MI), or Nonfatal Stroke.
timeFrame: Total follow-up time of up to approximately 6 years.
measure: Composite of CV Death or Nonfatal MI (Including Silent MI).
timeFrame: Total follow-up time of up to approximately 6 years.
measure: Fatal or Nonfatal MI (Including Silent MI).
timeFrame: Total follow-up time of up to approximately 6 years.
measure: Non-elective Coronary Revascularization Represented as the Composite of Emergent or Urgent Classifications.
timeFrame: Total follow-up time of up to approximately 6 years.
measure: CV Death.
timeFrame: Total follow-up time of up to approximately 6 years.
measure: Unstable Angina Determined to be Caused by Myocardial Ischemia by Invasive / Non-invasive Testing and Requiring Emergent Hospitalization.
timeFrame: Total follow-up time of up to approximately 6 years.
measure: Fatal or Nonfatal Stroke.
timeFrame: Total follow-up time of up to approximately 6 years.
measure: Total Mortality, Nonfatal MI (Including Silent MI), or Nonfatal Stroke.
timeFrame: Total follow-up time of up to approximately 6 years.
measure: Total Mortality.
timeFrame: Total follow-up time of up to approximately 6 years.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Amarin Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Amarin Investigational Site
state: Alabama
city: Huntsville
country: United States
facility: Amarin Investigational Site
state: Alabama
city: Mobile
country: United States
facility: Amarin Investigational Site
state: Alabama
city: Muscle Shoals
country: United States
facility: Amarin Investigational Site
state: Alabama
city: Mesa
country: United States
facility: Amarin Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Amarin Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Amarin Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: Amarin Investigational Site
state: Arkansas
city: Beverly Hills
country: United States
facility: Amarin Investigational Site
state: California
city: Chino
country: United States
facility: Amarin Investigational Site
state: California
city: Concord
country: United States
facility: Amarin Investigational Site
state: California
city: El Cajon
country: United States
facility: Amarin Investigational Site
state: California
city: Encino
country: United States
facility: Amarin Investigational Site
state: California
city: Fair Oaks
country: United States
facility: Amarin Investigational Site
state: California
city: Hawaiian Gardens
country: United States
facility: Amarin Investigational Site
state: California
city: Lancaster
country: United States
facility: Amarin Investigational Site
state: California
city: Lincoln
country: United States
facility: Amarin Investigational Site
state: California
city: Los Angeles
country: United States
facility: Amarin Investigational Site
state: California
city: Los Angeles
country: United States
facility: Amarin Investigational Site
state: California
city: Los Angeles
country: United States
facility: Amarin Investigational Site
state: California
city: National City
country: United States
facility: Amarin Investigational Site
state: California
city: Orange
country: United States
facility: Amarin Investigational Site
state: California
city: Paramount
country: United States
facility: Amarin Investigational Site
state: California
city: Roseville
country: United States
facility: Amarin Investigational Site
state: California
city: San Diego
country: United States
facility: Amarin Investigational Site
state: California
city: Torrance
country: United States
facility: Amarin Investigational Site
state: California
city: Ventura
country: United States
facility: Amarin Investigational Site
state: California
city: Walnut Creek
country: United States
facility: Amarin Investigational Site
state: California
city: Aurora
country: United States
facility: Amarin Investigational Site
state: Colorado
city: Colorado Springs
country: United States
facility: Amarin Investigational Site
state: Colorado
city: Golden
country: United States
facility: Amarin Investigational Site
state: Colorado
city: Guilford
country: United States
facility: Amarin Investigational Site
state: Connecticut
city: Hartford
country: United States
facility: Amarin Investigational Site
state: Connecticut
city: Newark
country: United States
facility: Amarin Investigational Site
state: Delaware
city: Wilmington
country: United States
facility: Amarin Investigational Site
state: Delaware
city: Washington
country: United States
facility: Amarin Investigational Site
state: District of Columbia
city: Boynton Beach
country: United States
facility: Amarin Investigational Site
state: Florida
city: Bradenton
country: United States
facility: Amarin Investigational Site
state: Florida
city: Clearwater
country: United States
facility: Amarin Investigational Site
state: Florida
city: Edgewater
country: United States
facility: Amarin Investigational Site
state: Florida
city: Fleming Island
country: United States
facility: Amarin Investigational Site
state: Florida
city: Fort Lauderdale
country: United States
facility: Amarin Investigational Site
state: Florida
city: Fort Lauderdale
country: United States
facility: Amarin Investigational Site
state: Florida
city: Inverness
country: United States
facility: Amarin Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Amarin Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Amarin Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Amarin Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Amarin Investigational Site
state: Florida
city: Miami Beach
country: United States
facility: Amarin Investigational Site
state: Florida
city: Miami Lakes
country: United States
facility: Amarin Investigational Site
state: Florida
city: Miami
country: United States
facility: Amarin Investigational Site
state: Florida
city: Miami
country: United States
facility: Amarin Investigational Site
state: Florida
city: Ocala
country: United States
facility: Amarin Investigational Site
state: Florida
city: Orlando
country: United States
facility: Amarin Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: Amarin Investigational Site
state: Florida
city: Plantation
country: United States
facility: Amarin Investigational Site
state: Florida
city: Safety Harbor
country: United States
facility: Amarin Investigational Site
state: Florida
city: Saint Petersburg
country: United States
facility: Amarin Investigational Site
state: Florida
city: Sarasota
country: United States
facility: Amarin Investigational Site
state: Florida
city: Vero Beach
country: United States
facility: Amarin Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Amarin Investigational Site
state: Florida
city: Conyers
country: United States
facility: Amarin Investigational Site
state: Georgia
city: Covington
country: United States
facility: Amarin Investigational Site
state: Georgia
city: Cumming
country: United States
facility: Amarin Investigational Site
state: Georgia
city: Roswell
country: United States
facility: Amarin Investigational Site
state: Georgia
city: Honolulu
country: United States
facility: Amarin Investigational Site
state: Hawaii
city: Addison
country: United States
facility: Amarin Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Amarin Investigational Site
state: Illinois
city: Norman
country: United States
facility: Amarin Investigational Site
state: Illinois
city: North Chicago
country: United States
facility: Amarin Investigational Site
state: Illinois
city: Peoria
country: United States
facility: Amarin Investigational Site
state: Illinois
city: Winfield
country: United States
facility: Amarin Investigational Site
state: Illinois
city: Evansville
country: United States
facility: Amarin Investigational Site
state: Indiana
city: Iowa City
country: United States
facility: Amarin Investigational Site
state: Iowa
city: Wichita
country: United States
facility: Amarin Investigational Site
state: Kansas
city: Wichita
country: United States
facility: Amarin Investigational Site
state: Kansas
city: Louisville
country: United States
facility: Amarin Investigational Site
state: Kentucky
city: Alexandria
country: United States
facility: Amarin Investigational Site
state: Louisiana
city: Eunice
country: United States
facility: Amarin Investigational Site
state: Louisiana
city: Marrero
country: United States
facility: Amarin Investigational Site
state: Louisiana
city: Auburn
country: United States
facility: Amarin Investigational Site
state: Maine
city: Baltimore
country: United States
facility: Amarin Investigational Site
state: Maryland
city: Lutherville
country: United States
facility: Amarin Investigational Site
state: Maryland
city: Takoma Park
country: United States
facility: Amarin Investigational Site
state: Maryland
city: Boston
country: United States
facility: Amarin Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: Amarin Investigational Site
state: Massachusetts
city: Fall River
country: United States
facility: Amarin Investigational Site
state: Massachusetts
city: Lansing
country: United States
facility: Amarin Investigational Site
state: Michigan
city: Marquette
country: United States
facility: Amarin Investigational Site
state: Michigan
city: Troy
country: United States
facility: Amarin Investigational Site
state: Michigan
city: Saint Cloud
country: United States
facility: Amarin Investigational Site
state: Minnesota
city: Biloxi
country: United States
facility: Amarin Investigational Site
state: Mississippi
city: Tupelo
country: United States
facility: Amarin Investigational Site
state: Mississippi
city: Chesterfield
country: United States
facility: Amarin Investigational Site
state: Missouri
city: Florissant
country: United States
facility: Amarin Investigational Site
state: Missouri
city: Jefferson City
country: United States
facility: Amarin Investigational Site
state: Missouri
city: Kansas City
country: United States
facility: Amarin Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Amarin Investigational Site
state: Missouri
city: Saint Peters
country: United States
facility: Amarin Investigational Site
state: Missouri
city: Hastings
country: United States
facility: Amarin Investigational Site
state: Nebraska
city: Omaha
country: United States
facility: Amarin Investigational Site
state: Nebraska
city: Omaha
country: United States
facility: Amarin Investigational Site
state: Nebraska
city: Henderson
country: United States
facility: Amarin Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Amarin Investigational Site
state: Nevada
city: Ocean City
country: United States
facility: Amarin Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: Amarin Investigational Site
state: New Mexico
city: Albany
country: United States
facility: Amarin Investigational Site
state: New York
city: Brooklyn
country: United States
facility: Amarin Investigational Site
state: New York
city: Great Neck
country: United States
facility: Amarin Investigational Site
state: New York
city: Liverpool
country: United States
facility: Amarin Investigational Site
state: New York
city: New York
country: United States
facility: Amarin Investigational Site
state: New York
city: New York
country: United States
facility: Amarin Investigational Site
state: New York
city: North Massapequa
country: United States
facility: Amarin Investigational Site
state: New York
city: Smithtown
country: United States
facility: Amarin Investigational Site
state: New York
city: Vestal
country: United States
facility: Amarin Investigational Site
state: New York
city: West Seneca
country: United States
facility: Amarin Investigational Site
state: New York
city: Charlotte
country: United States
facility: Amarin Investigational Site
state: North Carolina
city: Durham
country: United States
facility: Amarin Investigational Site
state: North Carolina
city: Gastonia
country: United States
facility: Amarin Investigational Site
state: North Carolina
city: Kernersville
country: United States
facility: Amarin Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Amarin Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Amarin Investigational Site
state: North Carolina
city: Fargo
country: United States
facility: Amarin Investigational Site
state: North Dakota
city: Cincinnati
country: United States
facility: Amarin Investigational Site
state: Ohio
city: Dayton
country: United States
facility: Amarin Investigational Site
state: Ohio
city: Lorain
country: United States
facility: Amarin Investigational Site
state: Ohio
city: Sandusky
country: United States
facility: Amarin Investigational Site
state: Ohio
city: Tulsa
country: United States
facility: Amarin Investigational Site
state: Oklahoma
city: Bend
country: United States
facility: Amarin Investigational Site
state: Oregon
city: Portland
country: United States
facility: Amarin Investigational Site
state: Oregon
city: Beaver
country: United States
facility: Amarin Investigational Site
state: Pennsylvania
city: Doylestown
country: United States
facility: Amarin Investigational Site
state: Pennsylvania
city: Jersey Shore
country: United States
facility: Amarin Investigational Site
state: Pennsylvania
city: Newport
country: United States
facility: Amarin Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Amarin Investigational Site
state: Pennsylvania
city: Phoenixville
country: United States
facility: Amarin Investigational Site
state: Pennsylvania
city: Sellersville
country: United States
facility: Amarin Investigational Site
state: Pennsylvania
city: Tipton
country: United States
facility: Amarin Investigational Site
state: Pennsylvania
city: Wyomissing
country: United States
facility: Amarin Investigational Site
state: Pennsylvania
city: Yardley
country: United States
facility: Amarin Investigational Site
state: Pennsylvania
city: Lancaster
country: United States
facility: Amarin Investigational Site
state: South Carolina
city: Simpsonville
country: United States
facility: Amarin Investigational Site
state: South Carolina
city: Rapid City
country: United States
facility: Amarin Investigational Site
state: South Dakota
city: Bristol
country: United States
facility: Amarin Investigational Site
state: Tennessee
city: Columbia
country: United States
facility: Amarin Investigational Site
state: Tennessee
city: Germantown
country: United States
facility: Amarin Investigational Site
state: Tennessee
city: Jackson
country: United States
facility: Amarin Investigational Site
state: Tennessee
city: Knoxville
country: United States
facility: Amarin Investigational Site
state: Tennessee
city: Smyrna
country: United States
facility: Amarin Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Amarin Investigational Site
state: Texas
city: Beaumont
country: United States
facility: Amarin Investigational Site
state: Texas
city: Carrollton
country: United States
facility: Amarin Investigational Site
state: Texas
city: Dallas
country: United States
facility: Amarin Investigational Site
state: Texas
city: Houston
country: United States
facility: Amarin Investigational Site
state: Texas
city: Houston
country: United States
facility: Amarin Investigational Site
state: Texas
city: Houston
country: United States
facility: Amarin Investigational Site
state: Texas
city: Houston
country: United States
facility: Amarin Investigational Site
state: Texas
city: Houston
country: United States
facility: Amarin Investigational Site
state: Texas
city: Houston
country: United States
facility: Amarin Investigational Site
state: Texas
city: Houston
country: United States
facility: Amarin Investigational Site
state: Texas
city: Hurst
country: United States
facility: Amarin Investigational Site
state: Texas
city: New Braunfels
country: United States
facility: Amarin Investigational Site
state: Texas
city: Plano
country: United States
facility: Amarin Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Amarin Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Amarin Investigational Site
state: Texas
city: Splendora
country: United States
facility: Amarin Investigational Site
state: Texas
city: Tomball
country: United States
facility: Amarin Investigational Site
state: Texas
city: West Jordan
country: United States
facility: Amarin Investigational Site
state: Utah
city: Falls Church
country: United States
facility: Amarin Investigational Site
state: Virginia
city: Manassas
country: United States
facility: Amarin Investigational Site
state: Virginia
city: Midlothian
country: United States
facility: Amarin Investigational Site
state: Virginia
city: Newport News
country: United States
facility: Amarin Investigational Site
state: Virginia
city: Burien
country: United States
facility: Amarin Investigational Site
state: Washington
city: Tacoma
country: United States
facility: Amarin Investigational Site
state: Washington
city: Huntington
country: United States
facility: Amarin Investigational Site
state: West Virginia
city: Camperdown
country: Australia
facility: Amarin Investigational Site
state: New South Wales
city: Lismore
country: Australia
facility: Amarin Investigational Site
state: New South Wales
city: Brisbane
country: Australia
facility: Amarin Investigational Site
state: Queensland
city: Chermside
country: Australia
facility: Amarin Investigational Site
state: Queensland
city: Bedford Park
country: Australia
facility: Amarin Investigational Site
state: South Australia
city: Launceston
country: Australia
facility: Amarin Investigational Site
state: Tasmania
city: Fitzroy
country: Australia
facility: Amarin Investigational Site
state: Victoria
city: Geelong
country: Australia
facility: Amarin Investigational Site
state: Victoria
city: Heidelberg Heights
country: Australia
facility: Amarin Investigational Site
state: Victoria
city: Melbourne
country: Australia
facility: Amarin Investigational Site
state: Victoria
city: Fremantle
country: Australia
facility: Amarin Investigational Site
state: Western Australia
city: Joondalup
country: Australia
facility: Amarin Investigational Site
state: Western Australia
city: Murdoch
country: Australia
facility: Amarin Investigational Site
state: Western Australia
city: Nedlands
country: Australia
facility: Amarin Investigational Site
state: Western Australia
city: Perth
country: Australia
facility: Amarin Investigational Site
state: Western Australia
city: Edmonton
country: Canada
facility: Amarin Investigational Site
state: Alberta
city: Coquitlam
country: Canada
facility: Amarin Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: Amarin Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: Amarin Investigational Site
state: British Columbia
city: Brampton
country: Canada
facility: Amarin Investigational Site
state: Ontario
city: Collingwood
country: Canada
facility: Amarin Investigational Site
state: Ontario
city: Corunna
country: Canada
facility: Amarin Investigational Site
state: Ontario
city: Newmarket
country: Canada
facility: Amarin Investigational Site
state: Ontario
city: Sarnia
country: Canada
facility: Amarin Investigational Site
state: Ontario
city: Strathroy
country: Canada
facility: Amarin Investigational Site
state: Ontario
city: Laval
country: Canada
facility: Amarin Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Amarin Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Amarin Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Amarin Investigational Site
state: Quebec
city: St. Charles-Borromée
country: Canada
facility: Amarin Investigational Site
state: Quebec
city: Québec
country: Canada
facility: Amarin Investigational Site
city: Québec
country: Canada
facility: Amarin Investigational Site
city: Hyderabad
country: India
facility: Amarin Investigational Site
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Amarin Investigational Site
state: Andhra Pradesh
city: Secunderabad
country: India
facility: Amarin Investigational Site
state: Andhra Pradesh
city: Visakhapatnam
country: India
facility: Amarin Investigational Site
state: Andhra Pradesh
city: New Delhi
country: India
facility: Amarin Investigational Site
state: Delhi
city: New Delhi
country: India
facility: Amarin Investigational Site
state: Delhi
city: Bangalore
country: India
facility: Amarin Investigational Site
state: Karnataka
city: Bangalore
country: India
facility: Amarin Investigational Site
state: Karnataka
city: Bangalore
country: India
facility: Amarin Investigational Site
state: Karnataka
city: Mysore
country: India
facility: Amarin Investigational Site
state: Karnataka
city: Mysore
country: India
facility: Amarin Investigational Site
state: Karnataka
city: Kottayam
country: India
facility: Amarin Investigational Site
state: Kerala
city: Mumbai
country: India
facility: Amarin Investigational Site
state: Maharashtra
city: Nashik
country: India
facility: Amarin Investigational Site
state: Maharashtra
city: Pune
country: India
facility: Amarin Investigational Site
state: Maharashtra
city: Chennai
country: India
facility: Amarin Investigational Site
state: Tamil Nadu
city: Coimbatore
country: India
facility: Amarin Investigational Site
state: Tamil Nadu
city: Almelo
country: Netherlands
facility: Amarin Investigational Site
city: Amersfoort
country: Netherlands
facility: Amarin Investigational Site
city: Blaricum
country: Netherlands
facility: Amarin Investigational Site
city: Capelle aan den Ijssel
country: Netherlands
facility: Amarin Investigational Site
city: Den Haag
country: Netherlands
facility: Amarin Investigational Site
city: Den Helder
country: Netherlands
facility: Amarin Investigational Site
city: Deventer
country: Netherlands
facility: Amarin Investigational Site
city: Ede
country: Netherlands
facility: Amarin Investigational Site
city: Eindhoven
country: Netherlands
facility: Amarin Investigational Site
city: Enschede
country: Netherlands
facility: Amarin Investigational Site
city: Goes
country: Netherlands
facility: Amarin Investigational Site
city: Gorinchem
country: Netherlands
facility: Amarin Investigational Site
city: Gouda
country: Netherlands
facility: Amarin Investigational Site
city: Groningen
country: Netherlands
facility: Amarin Investigational Site
city: Haarlem
country: Netherlands
facility: Amarin Investigational Site
city: Harderwijk
country: Netherlands
facility: Amarin Investigational Site
city: Heerenveen
country: Netherlands
facility: Amarin Investigational Site
city: Heerlen
country: Netherlands
facility: Amarin Investigational Site
city: Hoofddorp
country: Netherlands
facility: Amarin Investigational Site
city: Leeuwarden
country: Netherlands
facility: Amarin Investigational Site
city: Leiderdorp
country: Netherlands
facility: Amarin Investigational Site
city: Nijmegen
country: Netherlands
facility: Amarin Investigational Site
city: Roosendaal
country: Netherlands
facility: Amarin Investigational Site
city: Rotterdam
country: Netherlands
facility: Amarin Investigational Site
city: Rotterdam
country: Netherlands
facility: Amarin Investigational Site
city: Rotterdam
country: Netherlands
facility: Amarin Investigational Site
city: s'Hertogenbosch
country: Netherlands
facility: Amarin Investigational Site
city: Schiedam
country: Netherlands
facility: Amarin Investigational Site
city: Sneek
country: Netherlands
facility: Amarin Investigational Site
city: Tilburg
country: Netherlands
facility: Amarin Investigational Site
city: Tilburg
country: Netherlands
facility: Amarin Investigational Site
city: Uden
country: Netherlands
facility: Amarin Investigational Site
city: Veldhoven
country: Netherlands
facility: Amarin Investigational Site
city: Zoetermeer
country: Netherlands
facility: Amarin Investigational Site
city: Zutphen
country: Netherlands
facility: Amarin Investigational Site
city: Takapuna
country: New Zealand
facility: Amarin Investigational Site
state: Auckland
city: Christchurch
country: New Zealand
facility: Amarin Investigational Site
city: Dunedin
country: New Zealand
facility: Amarin Investigational Site
city: Hamilton
country: New Zealand
facility: Amarin Investigational Site
city: Hastings
country: New Zealand
facility: Amarin Investigational Site
city: Nelson
country: New Zealand
facility: Amarin Investigational Site
city: New Plymouth
country: New Zealand
facility: Amarin Investigational Site
city: Takapuna Auckland
country: New Zealand
facility: Amarin Investigational Site
city: Tauranga
country: New Zealand
facility: Amarin Investigational Site
city: Whangarei
country: New Zealand
facility: Amarin Investigational Site
city: Bialystok
country: Poland
facility: Amarin Investigational Site
city: Bialystok
country: Poland
facility: Amarin Investigational Site
city: Katowice
country: Poland
facility: Amarin Investigational Site
city: Katowice
country: Poland
facility: Amarin Investigational Site
city: Kraków
country: Poland
facility: Amarin Investigational Site
city: Mikolów
country: Poland
facility: Amarin Investigational Site
city: Skierniewice
country: Poland
facility: Amarin Investigational Site
city: Tarnów
country: Poland
facility: Amarin Investigational Site
city: Warszawa
country: Poland
facility: Amarin Investigational Site
city: Warszawa
country: Poland
facility: Amarin Investigational Site
city: Warszawska
country: Poland
facility: Amarin Investigational Site
city: Wroclaw
country: Poland
facility: Amarin Investigational Site
city: Wroclaw
country: Poland
facility: Amarin Investigational Site
city: Zgierz
country: Poland
facility: Amarin Investigational Site
city: Argeş
country: Romania
facility: Amarin Investigational Site
city: Brăila
country: Romania
facility: Amarin Investigational Site
city: Bucharest
country: Romania
facility: Amarin Investigational Site
city: Bucharest
country: Romania
facility: Amarin Investigational Site
city: Bucharest
country: Romania
facility: Amarin Investigational Site
city: Bucuresti
country: Romania
facility: Amarin Investigational Site
city: Bucuresti
country: Romania
facility: Amarin Investigational Site
city: Bucuresti
country: Romania
facility: Amarin Investigational Site
city: Cluj-Napoca
country: Romania
facility: Amarin Investigational Site
city: Constanţa
country: Romania
facility: Amarin Investigational Site
city: Craiova, Dolj
country: Romania
facility: Amarin Investigational Site
city: Iaşi
country: Romania
facility: Amarin Investigational Site
city: Maramureş
country: Romania
facility: Amarin Investigational Site
city: Mureş
country: Romania
facility: Amarin Investigational Site
city: Sibiu
country: Romania
facility: Amarin Investigational Site
city: Timişoara
country: Romania
facility: Amarin Investigational Site
city: Târgu Mureş
country: Romania
facility: Amarin Investigational Site
city: Arkhangelsk
country: Russian Federation
facility: Amarin Investigational Site
city: Arkhangelsk
country: Russian Federation
facility: Amarin Investigational Site
city: Arkhangelsk
country: Russian Federation
facility: Amarin Investigational Site
city: Ekaterinburg
country: Russian Federation
facility: Amarin Investigational Site
city: Ekaterinburg
country: Russian Federation
facility: Amarin Investigational Site
city: Kazan
country: Russian Federation
facility: Amarin Investigational Site
city: Kazan
country: Russian Federation
facility: Amarin Investigational Site
city: Kemerovo
country: Russian Federation
facility: Amarin Investigational Site
city: Kemerovo
country: Russian Federation
facility: Amarin Investigational Site
city: Kirovsk, Leningradskaya Region
country: Russian Federation
facility: Amarin Investigational Site
city: Krasnodar
country: Russian Federation
facility: Amarin Investigational Site
city: Moscow
country: Russian Federation
facility: Amarin Investigational Site
city: Moscow
country: Russian Federation
facility: Amarin Investigational Site
city: Moscow
country: Russian Federation
facility: Amarin Investigational Site
city: Moscow
country: Russian Federation
facility: Amarin Investigational Site
city: Moscow
country: Russian Federation
facility: Amarin Investigational Site
city: Moscow
country: Russian Federation
facility: Amarin Investigational Site
city: Moscow
country: Russian Federation
facility: Amarin Investigational Site
city: Moscow
country: Russian Federation
facility: Amarin Investigational Site
city: Moscow
country: Russian Federation
facility: Amarin Investigational Site
city: Moscow
country: Russian Federation
facility: Amarin Investigational Site
city: Moscow
country: Russian Federation
facility: Amarin Investigational Site
city: Nizhny Novgorod
country: Russian Federation
facility: Amarin Investigational Site
city: Novosibirsk
country: Russian Federation
facility: Amarin Investigational Site
city: Novosibirsk
country: Russian Federation
facility: Amarin Investigational Site
city: Novosibirsk
country: Russian Federation
facility: Amarin Investigational Site
city: Petrozavodsk
country: Russian Federation
facility: Amarin Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Amarin Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Amarin Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Amarin Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Amarin Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Amarin Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Amarin Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Amarin Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Amarin Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Amarin Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Amarin Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Amarin Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Amarin Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Amarin Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Amarin Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Amarin Investigational Site
city: Saratov
country: Russian Federation
facility: Amarin Investigational Site
city: Saratov
country: Russian Federation
facility: Amarin Investigational Site
city: Sestroretsk, Saint-Petersburg
country: Russian Federation
facility: Amarin Investigational Site
city: Tomsk
country: Russian Federation
facility: Amarin Investigational Site
city: Tomsk
country: Russian Federation
facility: Amarin Investigational Site
city: Volgograd
country: Russian Federation
facility: Amarin Investigational Site
city: Voronezh
country: Russian Federation
facility: Amarin Investigational Site
city: Voronezh
country: Russian Federation
facility: Amarin Investigational Site
city: Yaroslavl
country: Russian Federation
facility: Amarin Investigational Site
city: Yaroslavl
country: Russian Federation
facility: Amarin Investigational Site
city: Bloemfontein
country: South Africa
facility: Amarin Investigational Site
state: Freestate
city: Benoni
country: South Africa
facility: Amarin Investigational Site
state: Gauteng
city: Pretoria
country: South Africa
facility: Amarin Investigational Site
state: Gauteng
city: Soweto
country: South Africa
facility: Amarin Investigational Site
state: Gauteng
city: Witbank
country: South Africa
facility: Amarin Investigational Site
state: Gauteng
city: Durban
country: South Africa
facility: Amarin Investigational Site
state: KwaZulu-Natal
city: Newlands
country: South Africa
facility: Amarin Investigational Site
state: KwaZulu-Natal
city: Bellville
country: South Africa
facility: Amarin Investigational Site
state: Western Cape
city: Cape Town
country: South Africa
facility: Amarin Investigational Site
state: Western Cape
city: Durbanville
country: South Africa
facility: Amarin Investigational Site
state: Western Cape
city: Goodwood
country: South Africa
facility: Amarin Investigational Site
state: Western Cape
city: Kraaifontein
country: South Africa
facility: Amarin Investigational Site
state: Western Cape
city: Paarl
country: South Africa
facility: Amarin Investigational Site
state: Western Cape
city: Panorama
country: South Africa
facility: Amarin Investigational Site
state: Western Cape
city: Parow
country: South Africa
facility: Amarin Investigational Site
state: Western Cape
city: Pinelands
country: South Africa
facility: Amarin Investigational Site
state: Western Cape
city: Somerset West
country: South Africa
facility: Amarin Investigational Site
state: Western Cape
city: Worcester
country: South Africa
facility: Amarin Investigational Site
state: Western Cape
city: Lutsk
country: Ukraine
facility: Amarin Investigational Site
state: Volyn Region
city: Cherkasy
country: Ukraine
facility: Amarin Investigational Site
city: Chernivtsi
country: Ukraine
facility: Amarin Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: Amarin Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: Amarin Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: Amarin Investigational Site
city: Donetsk
country: Ukraine
facility: Amarin Investigational Site
city: Donetsk
country: Ukraine
facility: Amarin Investigational Site
city: Ivano-Frankivsk
country: Ukraine
facility: Amarin Investigational Site
city: Ivano-Frankivsk
country: Ukraine
facility: Amarin Investigational Site
city: Kharkiv
country: Ukraine
facility: Amarin Investigational Site
city: Kharkiv
country: Ukraine
facility: Amarin Investigational Site
city: Kharkiv
country: Ukraine
facility: Amarin Investigational Site
city: Kharkiv
country: Ukraine
facility: Amarin Investigational Site
city: Kyiv
country: Ukraine
facility: Amarin Investigational Site
city: Kyiv
country: Ukraine
facility: Amarin Investigational Site
city: Kyiv
country: Ukraine
facility: Amarin Investigational Site
city: Kyiv
country: Ukraine
facility: Amarin Investigational Site
city: Kyiv
country: Ukraine
facility: Amarin Investigational Site
city: Kyiv
country: Ukraine
facility: Amarin Investigational Site
city: Kyiv
country: Ukraine
facility: Amarin Investigational Site
city: Kyiv
country: Ukraine
facility: Amarin Investigational Site
city: Kyiv
country: Ukraine
facility: Amarin Investigational Site
city: Luhansk
country: Ukraine
facility: Amarin Investigational Site
city: Lutsk
country: Ukraine
facility: Amarin Investigational Site
city: Lviv
country: Ukraine
facility: Amarin Investigational Site
city: Odesa
country: Ukraine
facility: Amarin Investigational Site
city: Odesa
country: Ukraine
facility: Amarin Investigational Site
city: Odesa
country: Ukraine
facility: Amarin Investigational Site
city: Poltava
country: Ukraine
facility: Amarin Investigational Site
city: Ternopil
country: Ukraine
facility: Amarin Investigational Site
city: Uzhgorod
country: Ukraine
facility: Amarin Investigational Site
city: Uzhgorod
country: Ukraine
facility: Amarin Investigational Site
city: Vinnytsya
country: Ukraine
facility: Amarin Investigational Site
city: Vinnytsya
country: Ukraine
facility: Amarin Investigational Site
city: Zaporizhzhia
country: Ukraine
facility: Amarin Investigational Site
city: Zaporizhzhia
country: Ukraine
facility: Amarin Investigational Site
city: Zaporizhzhia
country: Ukraine
facility: Amarin Investigational Site
city: Zaporizhzhia
country: Ukraine
facility: Amarin Investigational Site
Study officials:
affiliation: Brigham and Women's Hospital, 75 Francis Street, Boston
name: Deepak L. Bhatt, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bhatt DL, Steg PG, Brinton EA, Jacobson TA, Miller M, Tardif JC, Ketchum SB, Doyle RT Jr, Murphy SA, Soni PN, Braeckman RA, Juliano RA, Ballantyne CM; REDUCE-IT Investigators. Rationale and design of REDUCE-IT: Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial. Clin Cardiol. 2017 Mar;40(3):138-148. doi: 10.1002/clc.22692. Epub 2017 Mar 15.
citation: Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Doyle RT Jr, Juliano RA, Jiao L, Granowitz C, Tardif JC, Ballantyne CM; REDUCE-IT Investigators. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019 Jan 3;380(1):11-22. doi: 10.1056/NEJMoa1812792. Epub 2018 Nov 10.
citation: Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Doyle RT Jr, Juliano RA, Jiao L, Granowitz C, Tardif JC, Gregson J, Pocock SJ, Ballantyne CM; REDUCE-IT Investigators. Effects of Icosapent Ethyl on Total Ischemic Events: From REDUCE-IT. J Am Coll Cardiol. 2019 Jun 11;73(22):2791-2802. doi: 10.1016/j.jacc.2019.02.032. Epub 2019 Mar 18.
citation: Bhatt DL, Miller M, Brinton EA, Jacobson TA, Steg PG, Ketchum SB, Doyle RT Jr, Juliano RA, Jiao L, Granowitz C, Tardif JC, Olshansky B, Chung MK, Gibson CM, Giugliano RP, Budoff MJ, Ballantyne CM; REDUCE-IT Investigators. REDUCE-IT USA: Results From the 3146 Patients Randomized in the United States. Circulation. 2020 Feb 4;141(5):367-375. doi: 10.1161/CIRCULATIONAHA.119.044440. Epub 2019 Nov 11.
citation: Olshansky B, Bhatt DL, Miller M, Steg PG, Brinton EA, Jacobson TA, Ketchum SB, Doyle RT Jr, Juliano RA, Jiao L, Granowitz C, Tardif JC, Mehta C, Mukherjee R, Ballantyne CM, Chung MK; REDUCE-IT Investigators. REDUCE-IT INTERIM: accumulation of data across prespecified interim analyses to final results. Eur Heart J Cardiovasc Pharmacother. 2021 May 23;7(3):e61-e63. doi: 10.1093/ehjcvp/pvaa118. No abstract available.
citation: Peterson BE, Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Juliano RA, Jiao L, Doyle RT Jr, Granowitz C, Gibson CM, Pinto D, Giugliano RP, Budoff MJ, Tardif JC, Verma S, Ballantyne CM; REDUCE-IT Investigators. Reduction in Revascularization With Icosapent Ethyl: Insights From REDUCE-IT Revascularization Analyses. Circulation. 2021 Jan 5;143(1):33-44. doi: 10.1161/CIRCULATIONAHA.120.050276. Epub 2020 Nov 5.
citation: Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Jiao L, Tardif JC, Gregson J, Pocock SJ, Ballantyne CM; REDUCE-IT Investigators. Reduction in First and Total Ischemic Events With Icosapent Ethyl Across Baseline Triglyceride Tertiles. J Am Coll Cardiol. 2019 Aug 27;74(8):1159-1161. doi: 10.1016/j.jacc.2019.06.043. No abstract available.
citation: Gaba P, Bhatt DL, Giugliano RP, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Juliano RA, Jiao L, Doyle RT Jr, Granowitz C, Tardif JC, Ballantyne CM, Pinto DS, Budoff MJ, Gibson CM. Comparative Reductions in Investigator-Reported and Adjudicated Ischemic Events in REDUCE-IT. J Am Coll Cardiol. 2021 Oct 12;78(15):1525-1537. doi: 10.1016/j.jacc.2021.08.009.
citation: Majithia A, Bhatt DL, Friedman AN, Miller M, Steg PG, Brinton EA, Jacobson TA, Ketchum SB, Juliano RA, Jiao L, Doyle RT Jr, Granowitz C, Budoff M, Preston Mason R, Tardif JC, Boden WE, Ballantyne CM. Benefits of Icosapent Ethyl Across the Range of Kidney Function in Patients With Established Cardiovascular Disease or Diabetes: REDUCE-IT RENAL. Circulation. 2021 Nov 30;144(22):1750-1759. doi: 10.1161/CIRCULATIONAHA.121.055560. Epub 2021 Oct 28.
citation: Verma S, Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Dhingra NK, Ketchum SB, Juliano RA, Jiao L, Doyle RT Jr, Granowitz C, Gibson CM, Pinto D, Giugliano RP, Budoff MJ, Mason RP, Tardif JC, Ballantyne CM; REDUCE-IT Investigators. Icosapent Ethyl Reduces Ischemic Events in Patients With a History of Previous Coronary Artery Bypass Grafting: REDUCE-IT CABG. Circulation. 2021 Dec 7;144(23):1845-1855. doi: 10.1161/CIRCULATIONAHA.121.056290. Epub 2021 Oct 28.
citation: Singh N, Bhatt DL, Miller M, Steg PG, Brinton EA, Jacobson TA, Jiao L, Tardif JC, Mason RP, Ballantyne CM; REDUCE-IT Investigators. Consistency of Benefit of Icosapent Ethyl by Background Statin Type in REDUCE-IT. J Am Coll Cardiol. 2022 Jan 18;79(2):220-222. doi: 10.1016/j.jacc.2021.11.005. No abstract available.
citation: Ridker PM, Rifai N, MacFadyen J, Glynn RJ, Jiao L, Steg PG, Miller M, Brinton EA, Jacobson TA, Tardif JC, Ballantyne CM, Mason RP, Bhatt DL. Effects of Randomized Treatment With Icosapent Ethyl and a Mineral Oil Comparator on Interleukin-1beta, Interleukin-6, C-Reactive Protein, Oxidized Low-Density Lipoprotein Cholesterol, Homocysteine, Lipoprotein(a), and Lipoprotein-Associated Phospholipase A2: A REDUCE-IT Biomarker Substudy. Circulation. 2022 Aug 2;146(5):372-379. doi: 10.1161/CIRCULATIONAHA.122.059410. Epub 2022 Jun 28.
citation: Gaba P, Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Juliano RA, Jiao L, Doyle RT Jr, Granowitz C, Tardif JC, Giugliano RP, Martens FMAC, Gibson CM, Ballantyne CM; REDUCE-IT Investigators. Prevention of Cardiovascular Events and Mortality With Icosapent Ethyl in Patients With Prior Myocardial Infarction. J Am Coll Cardiol. 2022 May 3;79(17):1660-1671. doi: 10.1016/j.jacc.2022.02.035.
citation: Selvaraj S, Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Juliano RA, Jiao L, Tardif JC, Ballantyne CM; REDUCE-IT Investigators. Impact of Icosapent Ethyl on Cardiovascular Risk Reduction in Patients With Heart Failure in REDUCE-IT. J Am Heart Assoc. 2022 Apr 5;11(7):e024999. doi: 10.1161/JAHA.121.024999. Epub 2022 Apr 4.
citation: Peterson BE, Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Juliano RA, Jiao L, Doyle RT Jr, Granowitz C, Gibson CM, Pinto D, Giugliano RP, Budoff MJ, Tardif JC, Verma S, Ballantyne CM; REDUCE-IT Investigators. Treatment With Icosapent Ethyl to Reduce Ischemic Events in Patients With Prior Percutaneous Coronary Intervention: Insights From REDUCE-IT PCI. J Am Heart Assoc. 2022 Mar 15;11(6):e022937. doi: 10.1161/JAHA.121.022937. Epub 2022 Mar 9.