Clinical trial NCT00643201: Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism
Official title: A Safety and Efficacy Trial Evaluating the Use of Apixaban in the Treatment of Symptomatic Deep Vein Thrombosis and Pulmonary Embolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Venous Thrombosis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2008-03-26
Enrollment: 5614
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients with deep vein thrombosis (DVT) or pulmonary embolism (PE)


Eligibility criteria: Inclusion Criteria:

* Men and women ≥ 18 years of age
* Clinical diagnosis of DVT or PE

Exclusion Criteria:

* Contraindications for enoxaparin or warfarin
* Active bleeding or high risk for serious bleeding
* Short life expectancy
* Uncontrolled high blood pressure
* Significantly impaired kidney or liver function

Primary outcomes:
measure: Incidence of Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or VTE-Related Death During 6 Months of Treatment
timeFrame: Day 1 to Week 24 + 2 Days or 355 days (Discontinued Early)
Secondary outcomes:
measure: Incidence of Adjudicated Composite of Recurrent Symptomatic Venous Thromboembolism (VTE) or All-Cause Death
timeFrame: Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)
measure: Incidence of Adjudicated Composite of Recurrent Symptomatic VTE or Cardiovascular (CV)-Related Death
timeFrame: Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)
measure: Incidence of Adjudicated Composite of Recurrent Symptomatic VTE or VTE-related Death or Major Bleeding
timeFrame: Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)
measure: Incidence of Adjudicated Composite of Recurrent Symptomatic VTE, Myocardial Infarction, Stroke, CV-related Death, Clinically Relevant Non-major (CRNM) Bleeding or Major Bleeding
timeFrame: Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)
measure: Incidence of Adjudicated Symptomatic Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period
timeFrame: Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)
measure: Incidence of Adjudicated Symptomatic Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period
timeFrame: Day 1 to Week 24 + + 2 Days or 355 Days (Discontinued Early)
measure: Incidence of Adjudicated Venous Thromboembolism (VTE)-Related Death During the Intended Treatment Period
timeFrame: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
measure: Incidence of Cardiovascular (CV)-Related Death Including VTE-related Death During the Intended Treatment Period
timeFrame: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
measure: Incidence of All-Cause Death During the Intended Treatment Period
timeFrame: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
measure: Incidence of Adjudicated Major Bleeding During the Treatment Period in Treated Participants
timeFrame: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
measure: Incidence of Adjudicated Major/CRNM Bleeding During the Treatment Period in Treated Participants
timeFrame: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
measure: Incidence of Adjudicated Clinically Relevant Non Major (CRNM) Bleeding During the Treatment Period in Treated Participants
timeFrame: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
measure: Incidence of Adjudicated Minor Bleeding During the Treatment Period in Treated Participants
timeFrame: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
measure: Incidence of Adjudicated Total Bleeding During the Treatment Period in Treated Participants
timeFrame: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
measure: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Bleeding AEs, Discontinuations Due to AEs and Death During the Treatment Period in Treated Participants
timeFrame: First dose to last dose of 24 Weeks + 2 days (AEs) or + 30 days (SAEs) or until drug discontinued
measure: Number of Treated Participants With Marked Abnormalities in Hematology Laboratory Tests
timeFrame: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
measure: Number of Treated Participants With Marked Abnormalities in Electrolyte Laboratory Tests
timeFrame: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
measure: Number of Treated Participants With Marked Abnormalities in Kidney and Liver Function Laboratory Tests
timeFrame: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
measure: Number of Treated Participants With Marked Abnormalities in Creatine Kinase, Uric Acid, and Total Protein Laboratory Tests
timeFrame: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
measure: Number of Treated Participants With Marked Abnormalities in Urinalysis Laboratory Tests
timeFrame: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics, Llc
state: Alabama
city: Mobile
country: United States
facility: Horizon Research Group, Inc.
state: Alabama
city: Fort Smith
country: United States
facility: Fort Smith Lung Center
state: Arkansas
city: Little Rock
country: United States
facility: University Of Arkansas For Medical Sciences
state: Arkansas
city: Banning
country: United States
facility: Beaver Medical Group
state: California
city: Fresno
country: United States
facility: University Of California San Francisco-Fresno
state: California
city: Sacramento
country: United States
facility: University Of California, Davis Medical Center
state: California
city: San Diego
country: United States
facility: Chest Medicine & Critical Care Medical Gr. Inc.
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Torrance
country: United States
facility: Harbor Ucla Medical Center
state: California
city: Golden
country: United States
facility: New West Physicians
state: Colorado
city: Wheat Ridge
country: United States
facility: Drogue Medical, Llc
state: Colorado
city: Bridgeport
country: United States
facility: Bridgeport Hospital
state: Connecticut
city: New Haven
country: United States
facility: Dept Of Internal Med, Sect Of Pulmonary & Critical Care Med
state: Connecticut
city: Washington
country: United States
facility: George Washington University Medical Faculty Associates
state: District of Columbia
city: Bay Pines
country: United States
facility: Bay Pines Va Healthcare Systems
state: Florida
city: Brandon
country: United States
facility: Daniel G. Lorch, Jr, Md, Cpi
state: Florida
city: Clearwater
country: United States
facility: Research Alliance, Inc.
state: Florida
city: Jacksonville
country: United States
facility: River City Clinical Research
state: Florida
city: St. Petersburg
country: United States
facility: Pasadena Center For Medical Research
state: Florida
city: Tampa
country: United States
facility: Tampa Clinical Research
state: Florida
city: Vero Beach
country: United States
facility: Office Of Michele S. Maholtz Md
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Atlanta
country: United States
facility: Atlanta Pulmonary Group
state: Georgia
city: Decatur
country: United States
facility: Atlanta Institute For Medical Research, Inc
state: Georgia
city: Savannah
country: United States
facility: Chatham Hospitalists
state: Georgia
city: Jerseyville
country: United States
facility: Gateway Cardiology. P.C
state: Illinois
city: Oak Park
country: United States
facility: West Suburban Medical Center
state: Illinois
city: Carmel
country: United States
facility: Infectious Disease Of Indiana Psc
state: Indiana
city: Windsor Heights
country: United States
facility: Heartland Vascular Medicine And Surgery
state: Iowa
city: Hazard
country: United States
facility: Kentucky Lung Clinic
state: Kentucky
city: Lexington
country: United States
facility: Univ. Of Kentucky Dept. Of Surgery
state: Kentucky
city: Owensboro
country: United States
facility: Research Integrity, Llc
state: Kentucky
city: Rockport
country: United States
facility: Pen Bay Medical Center
state: Maine
city: Annapolis
country: United States
facility: Anne Arundel Medical Center
state: Maryland
city: Baltimore
country: United States
facility: R Adams Cowley Shock Trauma Center
state: Maryland
city: Baltimore
country: United States
facility: Medstar Research Health Institute
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Flint
country: United States
facility: Hurley Medical Center
state: Michigan
city: Picayune
country: United States
facility: Mississippi Medical Research, Llc
state: Mississippi
city: Columbia
country: United States
facility: University Of Missouri-Columbia
state: Missouri
city: Kansas City
country: United States
facility: Veterans Affairs Medical Center
state: Missouri
city: St Louis
country: United States
facility: Washington University School Of Medicine
state: Missouri
city: St. Louis
country: United States
facility: St. John'S Mercy Medical Center
state: Missouri
city: Butte
country: United States
facility: Mercury Street Medical Group, Pllc
state: Montana
city: Great Falls
country: United States
facility: Great Falls Clinic, Llp
state: Montana
city: Grand Island
country: United States
facility: Internal Medical Associates Of Grand Island, P.C
state: Nebraska
city: Omaha
country: United States
facility: Creighton University Medical Center
state: Nebraska
city: Morristown
country: United States
facility: Morristown Memorial Hospital
state: New Jersey
city: Albany
country: United States
facility: Pulmonary & Critical Care Services, Pc
state: New York
city: Buffalo
country: United States
facility: Kaleida Health System
state: New York
city: Staten Island
country: United States
facility: Richmond University Medical Center
state: New York
city: Valhalla
country: United States
facility: New York Medical College
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Raleigh
country: United States
facility: Rex Healthcare
state: North Carolina
city: Statesville
country: United States
facility: Piedmont Healthcare/Research
state: North Carolina
city: Wilmington
country: United States
facility: Wilmington Medical Research
state: North Carolina
city: Winston Salem
country: United States
facility: Clinical Trials Of America, Inc.
state: North Carolina
city: Grand Forks
country: United States
facility: Altru Health System Clinic
state: North Dakota
city: Cleveland
country: United States
facility: Huron Hospital
state: Ohio
city: Columbus
country: United States
facility: Remington Davis Inc.
state: Ohio
city: Portland
country: United States
facility: Oregon Health Science University
state: Oregon
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Greenville
country: United States
facility: Greenville Hospital System
state: South Carolina
city: Summerville
country: United States
facility: Palmetto Clinical Research
state: South Carolina
city: Bristol
country: United States
facility: Holston Medical Group
state: Tennessee
city: Jackson
country: United States
facility: Kore Cv Research
state: Tennessee
city: Houston
country: United States
facility: Primecare Medical Group
state: Texas
city: San Antonio
country: United States
facility: Cancer Care Centers Of South Texas
state: Texas
city: Salt Lake City
country: United States
facility: University Of Utah Medical Center
state: Utah
city: Bellevue
country: United States
facility: Lake Washington Vascular, Pllc
state: Washington
city: Tacoma
country: United States
facility: Franciscan Research Center
state: Washington
city: Ciudad Autonoma De Buenos Aire
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Rosario
country: Argentina
facility: Local Institution
state: Santa Fe
city: Rosario
country: Argentina
facility: Local Institution
state: Santa Fe
city: Rosario
country: Argentina
facility: Local Institution
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Cordoba
country: Argentina
facility: Local Institution
city: Corrientes
country: Argentina
facility: Local Institution
city: Garran
country: Australia
facility: Local Institution
state: Australian Capital Territory
city: Concord
country: Australia
facility: Local Institution
state: New South Wales
city: Kogarah
country: Australia
facility: Local Institution
state: New South Wales
city: Lismore
country: Australia
facility: Local Institution
state: New South Wales
city: Randwick
country: Australia
facility: Local Institution
state: New South Wales
city: Herston
country: Australia
facility: Local Institution
state: Queensland
city: Adelaide
country: Australia
facility: Local Institution
state: South Australia
city: Bedford Park
country: Australia
facility: Local Institution
state: South Australia
city: Hobart
country: Australia
facility: Local Institution
state: Tasmania
city: Box Hill
country: Australia
facility: Local Institution
state: Victoria
city: Clayton
country: Australia
facility: Local Institution
state: Victoria
city: Ringwood East
country: Australia
facility: Local Institution
state: Victoria
city: Windsor
country: Australia
facility: Local Institution
state: Victoria
city: Perth
country: Australia
facility: Local Institution
state: Western Australia
city: Graz
country: Austria
facility: Local Institution
city: Innsbruck
country: Austria
facility: Local Institution
city: Vienna
country: Austria
facility: Local Institution
city: Vienna
country: Austria
facility: Local Institution
city: Vienna
country: Austria
facility: Local Institution
city: Vienna
country: Austria
facility: Local Institution
city: Wien
country: Austria
facility: Local Institution
city: Belo Horizonte - Mg
country: Brazil
facility: Local Institution
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Local Institution
state: Parana
city: Curitiba
country: Brazil
facility: Local Institution
state: Parana
city: Curitiba
country: Brazil
facility: Local Institution
state: Parana
city: Curitiba
country: Brazil
facility: Local Institution
state: Parana
city: Rio Janeiro
country: Brazil
facility: Local Institution
state: Rio De Janeiro
city: Port Alegre
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Botucatu
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Liberdade
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Sao Jose Do Rio Preto
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Sao Bernardo do Campo
country: Brazil
facility: Local Institution
state: SP
city: Rio De Janeiro
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: Vancouver
country: Canada
facility: Local Institution
state: British Columbia
city: Vancouver
country: Canada
facility: Local Institution
state: British Columbia
city: Victoria
country: Canada
facility: Local Institution
state: British Columbia
city: Winnipeg
country: Canada
facility: Local Institution
state: Manitoba
city: Saint John
country: Canada
facility: Local Institution
state: New Brunswick
city: Hamilton
country: Canada
facility: Local Institution
state: Ontario
city: Hamilton
country: Canada
facility: Local Institution
state: Ontario
city: Hamilton
country: Canada
facility: Local Institution
state: Ontario
city: Ottawa
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Waterloo
country: Canada
facility: Local Institution
state: Ontario
city: Windsor
country: Canada
facility: Local Institution
state: Ontario
city: Greenfield Park
country: Canada
facility: Local Institution
state: Quebec
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: St. Jerome
country: Canada
facility: Local Institution
state: Quebec
city: Punta Arenas
country: Chile
facility: Local Institution
state: Magallanes Antartica
city: Independencia
country: Chile
facility: Local Institution
state: Metropolitana
city: Santiago
country: Chile
facility: Local Institution
state: Metropolitana
city: Santiago
country: Chile
facility: Local Institution
state: Metropolitana
city: Vina Del Mar
country: Chile
facility: Local Institution
state: Valparaiso
city: Beijing
country: China
facility: Local Institution
state: Beijing
city: Beijing
country: China
facility: Local Institution
state: Beijing
city: Beijing
country: China
facility: Local Institution
state: Beijing
city: Beijing
country: China
facility: Local Institution
state: Beijing
city: Beijing
country: China
facility: Local Institution
state: Beijing
city: Beijing
country: China
facility: Local Institution
state: Beijing
city: Beijing
country: China
facility: Local Institution
state: Beijing
city: Beijing
country: China
facility: Local Institution
state: Beijing
city: Guangzhou
country: China
facility: Local Institution
state: Guangdong
city: Wuhan
country: China
facility: Local Institution
state: Hubei
city: Shengyang
country: China
facility: Local Institution
state: Liaoning
city: Shanghai
country: China
facility: Local Institution
state: Shanghai
city: Shanghai
country: China
facility: Local Institution
state: Shanghai
city: Hangzhou
country: China
facility: Local Institution
state: Zhejiang
city: Hangzhou
country: China
facility: Local Institution
state: Zhejiang
city: Xian
country: China
facility: Local Institution
city: Hradec Kralove
country: Czech Republic
facility: Local Institution
city: Kladno
country: Czech Republic
facility: Local Institution
city: Litomysl
country: Czech Republic
facility: Local Institution
city: Mestec Kralove
country: Czech Republic
facility: Local Institution
city: Ostrava Vitkovice
country: Czech Republic
facility: Local Institution
city: Ostrava
country: Czech Republic
facility: Local Institution
city: Praha 10
country: Czech Republic
facility: Local Institution
city: Praha 1
country: Czech Republic
facility: Local Institution
city: Praha 1
country: Czech Republic
facility: Local Institution
city: Praha 2
country: Czech Republic
facility: Local Institution
city: Usti Nad Labem
country: Czech Republic
facility: Local Institution
city: Usti Nad Orlici
country: Czech Republic
facility: Local Institution
city: Arhus C
country: Denmark
facility: Local Institution
city: Hellerup
country: Denmark
facility: Local Institution
city: Herning
country: Denmark
facility: Local Institution
city: Hilleroed
country: Denmark
facility: Local Institution
city: Horsens
country: Denmark
facility: Local Institution
city: Naestved
country: Denmark
facility: Local Institution
city: Silkeborg
country: Denmark
facility: Local Institution
city: Angers
country: France
facility: Local Institution
city: Arras
country: France
facility: Local Institution
city: Besancon
country: France
facility: Local Institution
city: Clamart
country: France
facility: Local Institution
city: Clermont-Ferrand Cedex 01
country: France
facility: Local Institution
city: Dijon
country: France
facility: Local Institution
city: Grenoble Cedex 9
country: France
facility: Local Institution
city: Langres Cedex
country: France
facility: Local Institution
city: Le Kremlin-Bicetre
country: France
facility: Local Institution
city: Lille Cedex
country: France
facility: Local Institution
city: Limoges Cedex
country: France
facility: Local Institution
city: Nantes
country: France
facility: Local Institution
city: Paris
country: France
facility: Local Institution
city: Paris
country: France
facility: Local Institution
city: Pierre Benite
country: France
facility: Local Institution
city: Saint-Priest En Jarez
country: France
facility: Local Institution
city: Toulouse cedex 9
country: France
facility: Local Institution
city: Vernon
country: France
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Bochum
country: Germany
facility: Local Institution
city: Cologne
country: Germany
facility: Local Institution
city: Dortmund
country: Germany
facility: Local Institution
city: Dresden
country: Germany
facility: Local Institution
city: Dresden
country: Germany
facility: Local Institution
city: Frankfurt
country: Germany
facility: Local Institution
city: Gottingen
country: Germany
facility: Local Institution
city: Karlsbad
country: Germany
facility: Local Institution
city: Ludwigshafen
country: Germany
facility: Local Institution
city: Mannheim
country: Germany
facility: Local Institution
city: Mannheim
country: Germany
facility: Local Institution
city: Munchen
country: Germany
facility: Local Institution
city: Munich
country: Germany
facility: Local Institution
city: Pokfulman
country: Hong Kong
facility: Local Institution
city: Shatin, N.T
country: Hong Kong
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Gyula
country: Hungary
facility: Local Institution
city: Kecskemet
country: Hungary
facility: Local Institution
city: Miskolc
country: Hungary
facility: Local Institution
city: Mosonmagyarovar
country: Hungary
facility: Local Institution
city: Szekesfehervar
country: Hungary
facility: Local Institution
city: Zalaegerszeg
country: Hungary
facility: Local Institution
city: Hyderabad
country: India
facility: Local Institution
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Local Institution
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: Local Institution
state: Gujarat
city: Gurgaon
country: India
facility: Local Institution
state: Haryana
city: Bangalore
country: India
facility: Local Institution
state: Karnataka
city: Bengaluru
country: India
facility: Local Institution
state: Karnataka
city: Manipal
country: India
facility: Local Institution
state: Karnataka
city: Pune
country: India
facility: Local Institution
state: Maharashtra
city: Mohali
country: India
facility: Local Institution
state: Punjab
city: Ludhiana
country: India
facility: Local Institution
state: Tagore Nagar
city: Chennai
country: India
facility: Local Institution
state: Tamil Nadu
city: Bangalore
country: India
facility: Local Institution
city: Bangalore
country: India
facility: Local Institution
city: Pune
country: India
facility: Local Institution
city: Tiberias
country: Israel
facility: Local Institution
state: Lower Galillee
city: Afula
country: Israel
facility: Local Institution
city: Ashkelon
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: Holon
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: Nahariya
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: Tel Hashomer
country: Israel
facility: Local Institution
city: Bologna
country: Italy
facility: Local Institution
city: Castelfranco Veneto (Tv)
country: Italy
facility: Local Institution
city: Chieti Scalo
country: Italy
facility: Local Institution
city: Cosenza
country: Italy
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Padova
country: Italy
facility: Local Institution
city: Palermo
country: Italy
facility: Local Institution
city: Pavia
country: Italy
facility: Local Institution
city: Piacenza
country: Italy
facility: Local Institution
city: Pisa
country: Italy
facility: Local Institution
city: Reggio Emilia
country: Italy
facility: Local Institution
city: Rome
country: Italy
facility: Local Institution
city: Rozzano (Mi)
country: Italy
facility: Local Institution
city: San Daniele Del Friuli (Ud)
country: Italy
facility: Local Institution
city: Vicenza
country: Italy
facility: Local Institution
city: Vittorio Veneto (Tv)
country: Italy
facility: Local Institution
city: Busan
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Georgetown
country: Malaysia
facility: Local Institution
state: Penang
city: Ipoh
country: Malaysia
facility: Local Institution
state: Perak
city: Kuala Lumpur
country: Malaysia
facility: Local Institution
city: Melaka
country: Malaysia
facility: Local Institution
city: Tijuana
country: Mexico
facility: Local Institution
state: Baja California
city: Leon
country: Mexico
facility: Local Institution
state: Guanajuato
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Zapopan
country: Mexico
facility: Local Institution
state: Jalisco
city: Zapopan
country: Mexico
facility: Local Institution
state: Jalisco
city: Monterrey
country: Mexico
facility: Local Institution
state: Nuevo Leon
city: Monterrey
country: Mexico
facility: Local Institution
state: Nuevo Leon
city: Xalapa
country: Mexico
facility: Local Institution
state: Veracruz
city: Aguascalientes
country: Mexico
facility: Local Institution
city: Durango
country: Mexico
facility: Local Institution
city: Alesund
country: Norway
facility: Local Institution
city: Fredrikstad
country: Norway
facility: Local Institution
city: Gjettum
country: Norway
facility: Local Institution
city: Gjovik
country: Norway
facility: Local Institution
city: Hamar
country: Norway
facility: Local Institution
city: Oslo
country: Norway
facility: Local Institution
city: Oslo
country: Norway
facility: Local Institution
city: Oslo
country: Norway
facility: Local Institution
city: Trondheim
country: Norway
facility: Local Institution
city: Tynset
country: Norway
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: Gdansk
country: Poland
facility: Local Institution
city: Gdynia
country: Poland
facility: Local Institution
city: Lodz
country: Poland
facility: Local Institution
city: Lublin
country: Poland
facility: Local Institution
city: Lublin
country: Poland
facility: Local Institution
city: Poznan
country: Poland
facility: Local Institution
city: Przeworsk
country: Poland
facility: Local Institution
city: Szczecin
country: Poland
facility: Local Institution
city: Warsawa
country: Poland
facility: Local Institution
city: Warsaw
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
city: Wroclaw
country: Poland
facility: Local Institution
city: Wroclaw
country: Poland
facility: Local Institution
city: Coimbra
country: Portugal
facility: Local Institution
city: Guarda
country: Portugal
facility: Local Institution
city: Lisboa
country: Portugal
facility: Local Institution
city: Lisboa
country: Portugal
facility: Local Institution
city: San Juan
country: Puerto Rico
facility: Local Institution
city: Baia Mare
country: Romania
facility: Local Institution
city: Bucharest
country: Romania
facility: Local Institution
city: Bucharest
country: Romania
facility: Local Institution
city: Bucharest
country: Romania
facility: Local Institution
city: Targu Mures
country: Romania
facility: Local Institution
city: Arkhangelsk
country: Russian Federation
facility: Local Institution
city: Chelyabinsk
country: Russian Federation
facility: Local Institution
city: Kazan
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: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Novosibirsk
country: Russian Federation
facility: Local Institution
city: Rostov-On Don
country: Russian Federation
facility: Local Institution
city: Ryazan
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: 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: Yaroslavl
country: Russian Federation
facility: Local Institution
city: Singapore
country: Singapore
facility: Local Institution
city: Singapore
country: Singapore
facility: Local Institution
city: Singapore
country: Singapore
facility: Local Institution
city: Bioemfontein
country: South Africa
facility: Local Institution
state: Free State
city: Centurion
country: South Africa
facility: Local Institution
state: Gauteng
city: Parktown
country: South Africa
facility: Local Institution
state: Gauteng
city: Pretoria
country: South Africa
facility: Local Institution
state: Gauteng
city: Durban
country: South Africa
facility: Local Institution
state: Kwa Zulu Natal
city: Pietermaritzburg
country: South Africa
facility: Local Institution
state: Kwa Zulu Natal
city: Bellville
country: South Africa
facility: Local Institution
state: Western Cape
city: George
country: South Africa
facility: Local Institution
state: Western Cape
city: Somerset West
country: South Africa
facility: Local Institution
state: Western Cape
city: Worcester
country: South Africa
facility: Local Institution
state: Western Cape
city: Torrevieja
country: Spain
facility: Local Institution
state: Alicante
city: Getafe
country: Spain
facility: Local Institution
city: L'Hospitalet De Llobregat
country: Spain
facility: Local Institution
city: Leon
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Malaga
country: Spain
facility: Local Institution
city: Mourente
country: Spain
facility: Local Institution
city: Tarragona
country: Spain
facility: Local Institution
city: Chernihiv
country: Ukraine
facility: Local Institution
city: Dnipropetrovsk
country: Ukraine
facility: Local Institution
city: Donetsk
country: Ukraine
facility: Local Institution
city: Ivano-Frankivsk
country: Ukraine
facility: Local Institution
city: Ivano-Frankivsk
country: Ukraine
facility: Local Institution
city: Kharkiv
country: Ukraine
facility: Local Institution
city: Kyiv
country: Ukraine
facility: Local Institution
city: Lviv
country: Ukraine
facility: Local Institution
city: Odesa
country: Ukraine
facility: Local Institution
city: Ternopil
country: Ukraine
facility: Local Institution
city: Vinnytsia
country: Ukraine
facility: Local Institution
city: Zaporizhzhia
country: Ukraine
facility: Local Institution
city: Livingston
country: United Kingdom
facility: Local Institution
state: West Lothian
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Jamieson MJ, Byon W, Dettloff RW, Crawford M, Gargalovic PS, Merali SJ, Onorato J, Quintero AJ, Russ C. Apixaban Use in Obese Patients: A Review of the Pharmacokinetic, Interventional, and Observational Study Data. Am J Cardiovasc Drugs. 2022 Nov;22(6):615-631. doi: 10.1007/s40256-022-00524-x. Epub 2022 May 16.
citation: Cohen AT, Pan S, Byon W, Ilyas BS, Taylor T, Lee TC. Efficacy, Safety, and Exposure of Apixaban in Patients with High Body Weight or Obesity and Venous Thromboembolism: Insights from AMPLIFY. Adv Ther. 2021 Jun;38(6):3003-3018. doi: 10.1007/s12325-021-01716-8. Epub 2021 Apr 22.
citation: Cohen AT, Agnelli G, Buller HR, Gallus A, Raskob GE, Sanders P, Thompson J, Weitz JI. Characteristics and Outcomes in Patients with Venous Thromboembolism Taking Concomitant Anti-Platelet Agents and Anticoagulants in the AMPLIFY Trial. Thromb Haemost. 2019 Mar;119(3):461-466. doi: 10.1055/s-0038-1676983. Epub 2019 Jan 16.
citation: Liu X, Johnson M, Mardekian J, Phatak H, Thompson J, Cohen AT. Apixaban Reduces Hospitalizations in Patients With Venous Thromboembolism: An Analysis of the Apixaban for the Initial Management of Pulmonary Embolism and Deep-Vein Thrombosis as First-Line Therapy (AMPLIFY) Trial. J Am Heart Assoc. 2015 Dec 1;4(12):e002340. doi: 10.1161/JAHA.115.002340.
citation: Agnelli G, Buller HR, Cohen A, Curto M, Gallus AS, Johnson M, Masiukiewicz U, Pak R, Thompson J, Raskob GE, Weitz JI; AMPLIFY Investigators. Oral apixaban for the treatment of acute venous thromboembolism. N Engl J Med. 2013 Aug 29;369(9):799-808. doi: 10.1056/NEJMoa1302507. Epub 2013 Jul 1.