Clinical trial NCT00313300: Safety Study of Apixaban in Recent Acute Coronary Syndrome
Official title: A Phase 2, Placebo-Controlled, Randomized, Double Blind, Parallel Arm, Dose Ranging Study to Evaluate Safety and Efficacy of Apixaban in Patients With a Recent Acute Coronary Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Coronary Syndrome (ACS)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-04-12
Enrollment: 1741
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this clinical research study is to determine whether apixaban will be safe in people who have recently had unstable angina or a heart attack.


Eligibility criteria: Key Inclusion Criteria:

* Recent (\< = 7 days) Acute Coronary Syndrome (ACS).
* Clinically stable on optimal treatment

Key Exclusion Criteria:

* High bleeding risk.
* Ongoing anticoagulant use.
* Need for chronic (\>3 months) daily nonsteroidal anti-inflammatory drug (NSAID) or chronic high dose acetylsalicylic acid (ASA) use (\>325 mg/day

Primary outcomes:
measure: Event Rate of Composite of Adjudicated Major Bleeding and Clinically Relevant Non-Major Bleeding During the Treatment Period- Treated Participants With Placebo or Apixaban Low Doses
timeFrame: From first dose of study drug (Day 1) to last dose plus 2 days, up to Year 2 of the Study
Secondary outcomes:
measure: Number of Participants With a Composite of Adjudicated Cardiovascular Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia and Non-Hemorrhagic Stroke During the Intended Treatment Period - Randomized Participants
timeFrame: Randomization to 182 days after randomization (183 days)
measure: Event Rate for Adjudicated All Bleeding Events During the Treatment Period - Treated Participants With Placebo or Apixaban Low Doses
timeFrame: first dose (Day 1) to last dose plus 2 days (or for SAEs, plus 30 days), up to Year 2 of the Study
measure: Number of Participants With a Composite of Adjudicated All-Cause Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, and Non-Hemorrhagic Stroke During the Intended Treatment Period - Randomized Participants
timeFrame: Day of randomization to 182 days after day of randomization (183 days)
measure: Event Rate of Confirmed Adjudicated Major Bleeding During the Treatment Period- Treated Participants With Placebo or Apixaban Low Doses
timeFrame: from first dose (Day 1) to last dose plus 2 days, up to Year 2 of the Study
measure: Number of Participants With Composite of Adjudicated All-Cause Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, Non-Hemorrhagic Stroke During the Phase B Adjusted Intended Treatment Period - Participants Randomized in Phase B
timeFrame: Day of randomization and ends on high dose termination date, 1-Oct-2007
measure: Event Rate of Composite of Adjudicated Major Bleeding and Clinically Relevant Non-Major Bleeding During the Phase B Adjusted Treatment Period- Treated Participants Randomized in Phase B
timeFrame: From first dose (Day 1) to last dose, plus 2 days (plus 30 days for SAEs), up to high dose termination, 1 October 2007
measure: Event Rate for Adjudicated All Bleeding Events During the Phase B Adjusted Treatment Period - Treated Participants Randomized in Phase B
timeFrame: From first dose (Day 1) to last dose, plus 2 days (plus 30 days for SAEs), up to high dose termination, 1 October 2007
measure: Number of Participants With Composite of Adjudicated Cardiovascular Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, Non-Hemorrhagic Stroke During the Phase B Adjusted Intended Treatment Period - Participants Randomized in Phase B
timeFrame: Day of randomization up to high dose termination, 1-Oct-2007
measure: Event Rate of Confirmed Adjudicated Major Bleeding During the Phase B Adjusted Treatment Period - Treated Participants Randomized in Phase B
timeFrame: From first dose (Day 1) to last dose, plus 2 days (plus 30 days for SAEs), up to high dose termination, 1 October 2007
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Scottsdale Cardiovasular Research Institute
state: Arizona
city: Los Angeles
country: United States
facility: Los Angeles County & University Of Southern Ca. Medical Cen.
state: California
city: Santa Rosa
country: United States
facility: Radiant Research,Santa Rosa
state: California
city: Littleton
country: United States
facility: South Denver Cardiology Associates
state: Colorado
city: Lakeland
country: United States
facility: Watson Clinic Center For Research
state: Florida
city: Safety Harbor
country: United States
facility: Heart & Vasc Inst Of Fl
state: Florida
city: Vero Beach
country: United States
facility: Indian River Medical Center
state: Florida
city: Atlanta
country: United States
facility: Cardiac Disease Specialists, P.C.
state: Georgia
city: Covington
country: United States
facility: Georgia Heart Specialists
state: Georgia
city: Peoria
country: United States
facility: Heartcare Midwest
state: Illinois
city: Indianapolis
country: United States
facility: The Care Group, Llc.
state: Indiana
city: Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Lexington
country: United States
facility: University Of Kentucky
state: Kentucky
city: Troy
country: United States
facility: William Beaumont Hospital-Troy
state: Michigan
city: New York
country: United States
facility: New York Cardiovascular Associates
state: New York
city: Chapel Hill
country: United States
facility: Unc Hospitals, Department Of Medicine
state: North Carolina
city: Durham
country: United States
facility: Dumc
state: North Carolina
city: Gastonia
country: United States
facility: Carolina Heart Specialists
state: North Carolina
city: Hickory
country: United States
facility: Piedmont Cardiology Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Univ Health Sciences
state: North Carolina
city: Columbus
country: United States
facility: Midwest Cardiology Research Foundation
state: Ohio
city: Dayton
country: United States
facility: The Dayton Heart Center
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Cardiovascular Research Group
state: Oklahoma
city: Danville
country: United States
facility: Geisinger Clinic - Cardiology
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Kingsport
country: United States
facility: Cardiovascular Associates, P.C
state: Tennessee
city: San Antonio
country: United States
facility: University Of Texas Medical School - San Antonio
state: Texas
city: Tyler
country: United States
facility: Tyler Cardiovascular Consultants
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Feldkirch
country: Austria
facility: Local Institution
city: Wien
country: Austria
facility: Local Institution
city: Wien
country: Austria
facility: Local Institution
city: Huy
country: Belgium
facility: Local Institution
state: Luik
city: Aalst
country: Belgium
facility: Local Institution
city: Antwerpen
country: Belgium
facility: Local Institution
city: Brasschaat
country: Belgium
facility: Local Institution
city: Brugge
country: Belgium
facility: Local Institution
city: Brussels
country: Belgium
facility: Local Institution
city: Genk
country: Belgium
facility: Local Institution
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: Victoria
country: Canada
facility: Local Institution
state: British Columbia
city: St. John'S
country: Canada
facility: Local Institution
state: Newfoundland and Labrador
city: Belleville
country: Canada
facility: Local Institution
state: Ontario
city: Chatham
country: Canada
facility: Local Institution
state: Ontario
city: Hamilton
country: Canada
facility: Local Institution
state: Ontario
city: London
country: Canada
facility: Local Institution
state: Ontario
city: Oshawa
country: Canada
facility: Local Institution
state: Ontario
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: St. Charles-Borromee
country: Canada
facility: Local Institution
state: Quebec
city: Terrebonne
country: Canada
facility: Local Institution
state: Quebec
city: Arhus C
country: Denmark
facility: Local Institution
city: Copenhagen
country: Denmark
facility: Local Institution
city: Esbjerg
country: Denmark
facility: Local Institution
city: Frederiksberg
country: Denmark
facility: Local Institution
city: Glostrup
country: Denmark
facility: Local Institution
city: Hellerup
country: Denmark
facility: Local Institution
city: Herning
country: Denmark
facility: Local Institution
city: Randers
country: Denmark
facility: Local Institution
city: Amiens Cedex 1
country: France
facility: Local Institution
city: Cholet
country: France
facility: Local Institution
city: Dijon
country: France
facility: Local Institution
city: Nantes Cedex 01
country: France
facility: Local Institution
city: Paris Cedex 13
country: France
facility: Local Institution
city: Pessac Cedex
country: France
facility: Local Institution
city: Roubaix Cedex 1
country: France
facility: Local Institution
city: Toulouse
country: France
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Duren
country: Germany
facility: Local Institution
city: Halle / Saale
country: Germany
facility: Local Institution
city: Hannover
country: Germany
facility: Local Institution
city: Krefeld
country: Germany
facility: Local Institution
city: Langen
country: Germany
facility: Local Institution
city: Ludwigshafen
country: Germany
facility: Local Institution
city: Witten
country: Germany
facility: Local Institution
city: Afula
country: Israel
facility: Local Institution
city: Hadera
country: Israel
facility: Local Institution
city: Haifa
country: Israel
facility: Local Institution
city: Haifa
country: Israel
facility: Local Institution
city: Jerusalem
country: Israel
facility: Local Institution
city: Jerusalem
country: Israel
facility: Local Institution
city: Jerusalem
country: Israel
facility: Local Institution
city: Kfar-Saba
country: Israel
facility: Local Institution
city: Nazareth
country: Israel
facility: Local Institution
city: Petach Tikva
country: Israel
facility: Local Institution
city: Rehovot
country: Israel
facility: Local Institution
city: Safed
country: Israel
facility: Local Institution
city: Tel Aviv
country: Israel
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Bialystok
country: Poland
facility: Local Institution
city: Bydgoszcz
country: Poland
facility: Local Institution
city: Bydgoszcz
country: Poland
facility: Local Institution
city: Bydgoszcz
country: Poland
facility: Local Institution
city: Cracow
country: Poland
facility: Local Institution
city: Gdansk
country: Poland
facility: Local Institution
city: Katowice
country: Poland
facility: Local Institution
city: Krakow
country: Poland
facility: Local Institution
city: Lodz
country: Poland
facility: Local Institution
city: Opole
country: Poland
facility: Local Institution
city: Torun
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
city: Zielona Gora
country: Poland
facility: Local Institution
city: Kemerovo
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Saint Petersburg
country: Russian Federation
facility: Local Institution
city: Saint Petersburg
country: Russian Federation
facility: Local Institution
city: Saint Petersburg
country: Russian Federation
facility: Local Institution
city: Saint Petersburg
country: Russian Federation
facility: Local Institution
city: Saratov
country: Russian Federation
facility: Local Institution
city: St. Petersburg
country: Russian Federation
facility: Local Institution
city: St.Petersburg
country: Russian Federation
facility: Local Institution
city: Yaroslavl
country: Russian Federation
facility: Local Institution
city: Yaroslav
country: Russian Federation
facility: Local Institution
city: Baracaldo (Vizcaya)
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Hospitalet Llobregat Barcelona
country: Spain
facility: Local Institution
city: Leon
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Malaga
country: Spain
facility: Local Institution
city: Oviedo
country: Spain
facility: Local Institution
city: Santiago De Compostela
country: Spain
facility: Local Institution
city: Sevilla
country: Spain
facility: Local Institution
city: Tarragona
country: Spain
facility: Local Institution
city: Valladolid
country: Spain
facility: Local Institution
city: Villajoyosa
country: Spain
facility: Local Institution
city: Goteborg
country: Sweden
facility: Local Institution
city: Goteborg
country: Sweden
facility: Local Institution
city: Malmo
country: Sweden
facility: Local Institution
city: Orebro
country: Sweden
facility: Local Institution
city: Stockholm
country: Sweden
facility: Local Institution
city: Sundsvall
country: Sweden
facility: Local Institution
city: Uppsala
country: Sweden
facility: Local Institution
city: Stockport
country: United Kingdom
facility: Local Institution
state: Cheshire
city: Harrow
country: United Kingdom
facility: Local Institution
state: Middlesex
city: Edinburgh
country: United Kingdom
facility: Local Institution
state: Midlothian
city: Portadown
country: United Kingdom
facility: Local Institution
state: N. Ireland
city: Sheffield
country: United Kingdom
facility: Local Institution
state: South Yorkshire
city: York
country: United Kingdom
facility: Local Institution
state: Yorkshire
city: Croydon
country: United Kingdom
facility: Local Institution
city: Leicester
country: United Kingdom
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: APPRAISE Steering Committee and Investigators; Alexander JH, Becker RC, Bhatt DL, Cools F, Crea F, Dellborg M, Fox KA, Goodman SG, Harrington RA, Huber K, Husted S, Lewis BS, Lopez-Sendon J, Mohan P, Montalescot G, Ruda M, Ruzyllo W, Verheugt F, Wallentin L. Apixaban, an oral, direct, selective factor Xa inhibitor, in combination with antiplatelet therapy after acute coronary syndrome: results of the Apixaban for Prevention of Acute Ischemic and Safety Events (APPRAISE) trial. Circulation. 2009 Jun 9;119(22):2877-85. doi: 10.1161/CIRCULATIONAHA.108.832139. Epub 2009 May 26.