Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism

A Safety and Efficacy Trial Evaluating the Use of Apixaban in the Treatment of Symptomatic Deep Vein Thrombosis and Pulmonary Embolism

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)

Study Overview

• Status: Completed
• Conditions: Venous Thrombosis
• Intervention / Treatment: Drug: Enoxaparin; Drug: warfarin; Drug: Placebo for apixaban; Drug: Placebo for enoxaparin; Drug: Placebo for warfarin; Drug: apixaban

• Study Type: Interventional
• Enrollment (Actual): 5614
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1280AEB
    • Local Institution
  • Cordoba, Argentina, 5000
    • Local Institution
  • Corrientes, Argentina, 3400
    • Local Institution
  • Buenos Aires
    • Ciudad Autonoma De Buenos Aire, Buenos Aires, Argentina, C1180AAX
      • Local Institution
  • Santa Fe
    • Rosario, Santa Fe, Argentina, 2000
      • Local Institution
    • Rosario, Santa Fe, Argentina, S2000CVB
      • Local Institution
    • Rosario, Santa Fe, Argentina, S2000DSV
      • Local Institution
• Australia
  • Australian Capital Territory
    • Garran, Australian Capital Territory, Australia, 2605
      • Local Institution
  • New South Wales
    • Concord, New South Wales, Australia, 2139
      • Local Institution
    • Kogarah, New South Wales, Australia, 2217
      • Local Institution
    • Lismore, New South Wales, Australia, 2480
      • Local Institution
    • Randwick, New South Wales, Australia, 2031
      • Local Institution
  • Queensland
    • Herston, Queensland, Australia, 4029
      • Local Institution
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Local Institution
    • Bedford Park, South Australia, Australia, 5042
      • Local Institution
  • Tasmania
    • Hobart, Tasmania, Australia, 7000
      • Local Institution
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Local Institution
    • Clayton, Victoria, Australia, 3168
      • Local Institution
    • Ringwood East, Victoria, Australia, 3135
      • Local Institution
    • Windsor, Victoria, Australia, 3181
      • Local Institution
  • Western Australia
    • Perth, Western Australia, Australia, 6001
      • Local Institution
• Austria
  • Graz, Austria, 8036
    • Local Institution
  • Innsbruck, Austria, 6020
    • Local Institution
  • Vienna, Austria, 1100
    • Local Institution
  • Vienna, Austria, 1090
    • Local Institution
  • Vienna, Austria, 1140
    • Local Institution
  • Vienna, Austria, 1160
    • Local Institution
  • Wien, Austria, 1090
    • Local Institution
• Brazil
  • Rio De Janeiro, Brazil, 20551
    • Local Institution
  • Sao Paulo, Brazil, 01323
    • Local Institution
  • Sao Paulo, Brazil, 04005
    • Local Institution
  • Sao Paulo, Brazil, 05403
    • Local Institution
  • Sao Paulo, Brazil, 04025
    • Local Institution
  • Minas Gerais
    • Belo Horizonte - Mg, Minas Gerais, Brazil, 30150
      • Local Institution
  • Parana
    • Curitiba, Parana, Brazil, 80050
      • Local Institution
    • Curitiba, Parana, Brazil, 80810
      • Local Institution
    • Curitiba, Parana, Brazil, 81520
      • Local Institution
    • Curitiba, Parana, Brazil, 80035
      • Local Institution
  • Rio De Janeiro
    • Rio Janeiro, Rio De Janeiro, Brazil, 22280
      • Local Institution
  • Rio Grande Do Sul
    • Port Alegre, Rio Grande Do Sul, Brazil, 90020
      • Local Institution
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035
      • Local Institution
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90610
      • Local Institution
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90110
      • Local Institution
  • SP
    • Sao Bernardo do Campo, SP, Brazil, 09715
      • Local Institution
  • Sao Paulo
    • Botucatu, Sao Paulo, Brazil, 18618
      • Local Institution
    • Liberdade, Sao Paulo, Brazil, 01509
      • Local Institution
    • Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15090
      • Local Institution
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • Local Institution
    • Edmonton, Alberta, Canada, T5H 4B9
      • Local Institution
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Local Institution
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • Local Institution
    • Victoria, British Columbia, Canada, V8R 6R5
      • Local Institution
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2H 2A6
      • Local Institution
  • New Brunswick
    • Saint John, New Brunswick, Canada, E2L 4L2
      • Local Institution
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Local Institution
    • Hamilton, Ontario, Canada, L8S 4K1
      • Local Institution
    • Hamilton, Ontario, Canada, L8N 4A6
      • Local Institution
    • Ottawa, Ontario, Canada, K1Y 4E9
      • Local Institution
    • Toronto, Ontario, Canada, M5G 2C4
      • Local Institution
    • Waterloo, Ontario, Canada, N2J 1C4
      • Local Institution
    • Windsor, Ontario, Canada, N8X 5A6
      • Local Institution
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • Local Institution
    • Montreal, Quebec, Canada, H1T 2M4
      • Local Institution
    • St. Jerome, Quebec, Canada, J7Z 5T3
      • Local Institution
• Chile
  • Magallanes Antartica
    • Punta Arenas, Magallanes Antartica, Chile, 6212296
      • Local Institution
  • Metropolitana
    • Independencia, Metropolitana, Chile, XXXXX
      • Local Institution
    • Santiago, Metropolitana, Chile, 7600448
      • Local Institution
    • Santiago, Metropolitana, Chile, 8330024
      • Local Institution
  • Valparaiso
    • Vina Del Mar, Valparaiso, Chile, 2520000
      • Local Institution
• China
  • Xian, China, 710032
    • Local Institution
  • Beijing
    • Beijing, Beijing, China, 100191
      • Local Institution
    • Beijing, Beijing, China, 100029
      • Local Institution
    • Beijing, Beijing, China, 100032
      • Local Institution
    • Beijing, Beijing, China, 100020
      • Local Institution
    • Beijing, Beijing, China, 100035
      • Local Institution
    • Beijing, Beijing, China, 100037
      • Local Institution
    • Beijing, Beijing, China, 100038
      • Local Institution
    • Beijing, Beijing, China, 100053
      • Local Institution
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Local Institution
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Local Institution
  • Liaoning
    • Shengyang, Liaoning, China, 110004
      • Local Institution
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Local Institution
    • Shanghai, Shanghai, China, 200127
      • Local Institution
  • Zhejiang
    • Hangzhou, Zhejiang, China, 130016
      • Local Institution
    • Hangzhou, Zhejiang, China, 310016
      • Local Institution
• Czech Republic
  • Hradec Kralove, Czech Republic, 500 05
    • Local Institution
  • Kladno, Czech Republic, 272 59
    • Local Institution
  • Litomysl, Czech Republic, 570 14
    • Local Institution
  • Mestec Kralove, Czech Republic, 289 03
    • Local Institution
  • Ostrava, Czech Republic, 708 52
    • Local Institution
  • Ostrava Vitkovice, Czech Republic, 703 84
    • Local Institution
  • Praha 1, Czech Republic, 110 00
    • Local Institution
  • Praha 1, Czech Republic, 118 33
    • Local Institution
  • Praha 10, Czech Republic, 100 34
    • Local Institution
  • Praha 2, Czech Republic, 128 08
    • Local Institution
  • Usti Nad Labem, Czech Republic, 401 13
    • Local Institution
  • Usti Nad Orlici, Czech Republic, 562 18
    • Local Institution
• Denmark
  • Arhus C, Denmark, 8000
    • Local Institution
  • Hellerup, Denmark, 2900
    • Local Institution
  • Herning, Denmark, 7400
    • Local Institution
  • Hilleroed, Denmark, 3400
    • Local Institution
  • Horsens, Denmark, 8700
    • Local Institution
  • Naestved, Denmark, 4700
    • Local Institution
  • Silkeborg, Denmark, 8600
    • Local Institution
• France
  • Angers, France, 49000
    • Local Institution
  • Arras, France, 62022
    • Local Institution
  • Besancon, France, 25000
    • Local Institution
  • Clamart, France, 92141
    • Local Institution
  • Clermont-Ferrand Cedex 01, France, 63003
    • Local Institution
  • Dijon, France, 21079
    • Local Institution
  • Grenoble Cedex 9, France, 38043
    • Local Institution
  • Langres Cedex, France, 52206
    • Local Institution
  • Le Kremlin-Bicetre, France, 94275
    • Local Institution
  • Lille Cedex, France, 59020
    • Local Institution
  • Limoges Cedex, France, 87042
    • Local Institution
  • Nantes, France, 44093
    • Local Institution
  • Paris, France, 75010
    • Local Institution
  • Paris, France, 75004
    • Local Institution
  • Pierre Benite, France, 69495
    • Local Institution
  • Saint-Priest En Jarez, France, 42270
    • Local Institution
  • Toulouse cedex 9, France, 31059
    • Local Institution
  • Vernon, France, 27200
    • Local Institution
• Germany
  • Berlin, Germany, 14050
    • Local Institution
  • Berlin, Germany, 10117
    • Local Institution
  • Berlin, Germany, 10787
    • Local Institution
  • Berlin, Germany, 12559
    • Local Institution
  • Bochum, Germany, 44791
    • Local Institution
  • Cologne, Germany, 50937
    • Local Institution
  • Dortmund, Germany, 44137
    • Local Institution
  • Dresden, Germany, 01307
    • Local Institution
  • Dresden, Germany, 01067
    • Local Institution
  • Frankfurt, Germany, 60596
    • Local Institution
  • Gottingen, Germany, 37075
    • Local Institution
  • Karlsbad, Germany, 76307
    • Local Institution
  • Ludwigshafen, Germany, 67063
    • Local Institution
  • Mannheim, Germany, 68161
    • Local Institution
  • Mannheim, Germany, 68163
    • Local Institution
  • Munchen, Germany, 80331
    • Local Institution
  • Munich, Germany, 80336
    • Local Institution
• Hong Kong
  • Pokfulman, Hong Kong, XXXXX
    • Local Institution
  • Shatin, N.T, Hong Kong
    • Local Institution
• Hungary
  • Budapest, Hungary, 1125
    • Local Institution
  • Budapest, Hungary, 1097
    • Local Institution
  • Budapest, Hungary, 1032
    • Local Institution
  • Gyula, Hungary, 5700
    • Local Institution
  • Kecskemet, Hungary, 6000
    • Local Institution
  • Miskolc, Hungary, 3501
    • Local Institution
  • Mosonmagyarovar, Hungary, 9200
    • Local Institution
  • Szekesfehervar, Hungary, 8000
    • Local Institution
  • Zalaegerszeg, Hungary, 8900
    • Local Institution
• India
  • Bangalore, India, 560052
    • Local Institution
  • Bangalore, India, 560099
    • Local Institution
  • Pune, India, 411001
    • Local Institution
  • Andhra Pradesh
    • Hyderabad, Andhra Pradesh, India, 500 082
      • Local Institution
    • Hyderabad, Andhra Pradesh, India, 500034
      • Local Institution
  • Gujarat
    • Ahmedabad, Gujarat, India, 380006
      • Local Institution
  • Haryana
    • Gurgaon, Haryana, India, 122001
      • Local Institution
  • Karnataka
    • Bangalore, Karnataka, India, 560054
      • Local Institution
    • Bengaluru, Karnataka, India, 560017
      • Local Institution
    • Manipal, Karnataka, India, 576104
      • Local Institution
  • Maharashtra
    • Pune, Maharashtra, India, 411001
      • Local Institution
  • Punjab
    • Mohali, Punjab, India, 160062
      • Local Institution
  • Tagore Nagar
    • Ludhiana, Tagore Nagar, India, 141001
      • Local Institution
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 600 006
      • Local Institution
• Israel
  • Afula, Israel, 18101
    • Local Institution
  • Ashkelon, Israel, 78278
    • Local Institution
  • Hadera, Israel, 38101
    • Local Institution
  • Haifa, Israel, 31096
    • Local Institution
  • Haifa, Israel, 31048
    • Local Institution
  • Holon, Israel, 58100
    • Local Institution
  • Jerusalem, Israel, 91120
    • Local Institution
  • Jerusalem, Israel, 91031
    • Local Institution
  • Kfar Saba, Israel, 44281
    • Local Institution
  • Nahariya, Israel, 22100
    • Local Institution
  • Petach-Tikva, Israel, 49100
    • Local Institution
  • Rehovot, Israel, 76100
    • Local Institution
  • Safed, Israel, 13100
    • Local Institution
  • Tel Aviv, Israel, 64239
    • Local Institution
  • Tel Hashomer, Israel, 52621
    • Local Institution
  • Lower Galillee
    • Tiberias, Lower Galillee, Israel, 15208
      • Local Institution
• Italy
  • Bologna, Italy, 40138
    • Local Institution
  • Castelfranco Veneto (Tv), Italy, 31033
    • Local Institution
  • Chieti Scalo, Italy, 66013
    • Local Institution
  • Cosenza, Italy, 87100
    • Local Institution
  • Milano, Italy, 20132
    • Local Institution
  • Padova, Italy, 35128
    • Local Institution
  • Palermo, Italy, 90127
    • Local Institution
  • Pavia, Italy, 27100
    • Local Institution
  • Piacenza, Italy, 29100
    • Local Institution
  • Pisa, Italy, 56124
    • Local Institution
  • Reggio Emilia, Italy, 42100
    • Local Institution
  • Rome, Italy, 00168
    • Local Institution
  • Rozzano (Mi), Italy, 20089
    • Local Institution
  • San Daniele Del Friuli (Ud), Italy, 33038
    • Local Institution
  • Vicenza, Italy, 36100
    • Local Institution
  • Vittorio Veneto (Tv), Italy, 31029
    • Local Institution
• Korea, Republic of
  • Busan, Korea, Republic of, 602-702
    • Local Institution
  • Seoul, Korea, Republic of, 137-040
    • Local Institution
  • Seoul, Korea, Republic of, 120752
    • Local Institution
  • Seoul, Korea, Republic of, 138736
    • Local Institution
• Malaysia
  • Kuala Lumpur, Malaysia, 50586
    • Local Institution
  • Melaka, Malaysia, 75400
    • Local Institution
  • Penang
    • Georgetown, Penang, Malaysia, 10350
      • Local Institution
  • Perak
    • Ipoh, Perak, Malaysia, 30990
      • Local Institution
• Mexico
  • Aguascalientes, Mexico, 20230
    • Local Institution
  • Durango, Mexico, 34080
    • Local Institution
  • Baja California
    • Tijuana, Baja California, Mexico, 22500
      • Local Institution
  • Guanajuato
    • Leon, Guanajuato, Mexico, 37320
      • Local Institution
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44280
      • Local Institution
    • Zapopan, Jalisco, Mexico, 45170
      • Local Institution
    • Zapopan, Jalisco, Mexico, 45200
      • Local Institution
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64000
      • Local Institution
    • Monterrey, Nuevo Leon, Mexico, 64718
      • Local Institution
  • Veracruz
    • Xalapa, Veracruz, Mexico, 91020
      • Local Institution
• Norway
  • Alesund, Norway, 6017
    • Local Institution
  • Fredrikstad, Norway, 1606
    • Local Institution
  • Gjettum, Norway, 1346
    • Local Institution
  • Gjovik, Norway, 2819
    • Local Institution
  • Hamar, Norway, 2318
    • Local Institution
  • Oslo, Norway, 0407
    • Local Institution
  • Oslo, Norway, 0319
    • Local Institution
  • Oslo, Norway, 0456
    • Local Institution
  • Trondheim, Norway, 7006
    • Local Institution
  • Tynset, Norway, 2500
    • Local Institution
• Poland
  • Bialystok, Poland, 15-276
    • Local Institution
  • Bydgoszcz, Poland, 85-168
    • Local Institution
  • Bydgoszcz, Poland, 85-681
    • Local Institution
  • Gdansk, Poland, 80-803
    • Local Institution
  • Gdynia, Poland, 81-348
    • Local Institution
  • Lodz, Poland, 90-153
    • Local Institution
  • Lublin, Poland, 20-081
    • Local Institution
  • Lublin, Poland, 20-718
    • Local Institution
  • Poznan, Poland, 61-848
    • Local Institution
  • Przeworsk, Poland, 37-200
    • Local Institution
  • Szczecin, Poland, 70-111
    • Local Institution
  • Warsaw, Poland, 02-005
    • Local Institution
  • Warsawa, Poland, 02-776
    • Local Institution
  • Warszawa, Poland, 01-138
    • Local Institution
  • Wroclaw, Poland, 50-981
    • Local Institution
  • Wroclaw, Poland, 51-124
    • Local Institution
• Portugal
  • Coimbra, Portugal, 3004-548
    • Local Institution
  • Guarda, Portugal, 6301-857
    • Local Institution
  • Lisboa, Portugal, 1769-001
    • Local Institution
  • Lisboa, Portugal, 1169-050
    • Local Institution
• Puerto Rico
  • San Juan, Puerto Rico, 00921
    • Local Institution
• Romania
  • Baia Mare, Romania, 430031
    • Local Institution
  • Bucharest, Romania, 030171
    • Local Institution
  • Bucharest, Romania, 022328
    • Local Institution
  • Bucharest, Romania, 050098
    • Local Institution
  • Targu Mures, Romania, 540136
    • Local Institution
• Russian Federation
  • Arkhangelsk, Russian Federation, 163045
    • Local Institution
  • Chelyabinsk, Russian Federation, 454136
    • Local Institution
  • Kazan, Russian Federation, 420101
    • Local Institution
  • Moscow, Russian Federation, 111539
    • Local Institution
  • Moscow, Russian Federation, 119049
    • Local Institution
  • Moscow, Russian Federation, 127473
    • Local Institution
  • Moscow, Russian Federation, 109386
    • Local Institution
  • Moscow, Russian Federation, 115093
    • Local Institution
  • Moscow, Russian Federation, 115280
    • Local Institution
  • Moscow, Russian Federation, 117292
    • Local Institution
  • Moscow, Russian Federation, 121359
    • Local Institution
  • Moscow, Russian Federation, 121552
    • Local Institution
  • Novosibirsk, Russian Federation, 630090
    • Local Institution
  • Rostov-On Don, Russian Federation, 344022
    • Local Institution
  • Ryazan, Russian Federation, 390026
    • Local Institution
  • Saint Petersburg, Russian Federation, 192242
    • Local Institution
  • Saint Petersburg, Russian Federation, 197022
    • Local Institution
  • Saint-Petersburg, Russian Federation, 196247
    • Local Institution
  • Saint-Petersburg, Russian Federation, 199106
    • Local Institution
  • Saint-Petersburg, Russian Federation, 197341
    • Local Institution
  • Saratov, Russian Federation, 410012
    • Local Institution
  • St Petersburg, Russian Federation, 194044
    • Local Institution
  • Yaroslavl, Russian Federation, 150062
    • Local Institution
• Singapore
  • Singapore, Singapore, 308433
    • Local Institution
  • Singapore, Singapore, 529889
    • Local Institution
  • Singapore, Singapore, 169608
    • Local Institution
• South Africa
  • Free State
    • Bioemfontein, Free State, South Africa, 9301
      • Local Institution
  • Gauteng
    • Centurion, Gauteng, South Africa, 0157
      • Local Institution
    • Parktown, Gauteng, South Africa, 2193
      • Local Institution
    • Pretoria, Gauteng, South Africa, 0084
      • Local Institution
  • Kwa Zulu Natal
    • Durban, Kwa Zulu Natal, South Africa, 4001
      • Local Institution
    • Pietermaritzburg, Kwa Zulu Natal, South Africa, 3201
      • Local Institution
  • Western Cape
    • Bellville, Western Cape, South Africa, 7530
      • Local Institution
    • George, Western Cape, South Africa, 6529
      • Local Institution
    • Somerset West, Western Cape, South Africa, 7130
      • Local Institution
    • Worcester, Western Cape, South Africa, 6850
      • Local Institution
• Spain
  • Getafe, Spain, 28905
    • Local Institution
  • L'Hospitalet De Llobregat, Spain, 08907
    • Local Institution
  • Leon, Spain, 24008
    • Local Institution
  • Madrid, Spain, 28041
    • Local Institution
  • Madrid, Spain, 28007
    • Local Institution
  • Madrid, Spain, 28029
    • Local Institution
  • Malaga, Spain, 29010
    • Local Institution
  • Mourente, Spain, 36071
    • Local Institution
  • Tarragona, Spain, 43007
    • Local Institution
  • Alicante
    • Torrevieja, Alicante, Spain, 03186
      • Local Institution
• Ukraine
  • Chernihiv, Ukraine, 14034
    • Local Institution
  • Dnipropetrovsk, Ukraine, 49000
    • Local Institution
  • Donetsk, Ukraine, 83045
    • Local Institution
  • Ivano-Frankivsk, Ukraine, 76008
    • Local Institution
  • Ivano-Frankivsk, Ukraine, 76018
    • Local Institution
  • Kharkiv, Ukraine, 61018
    • Local Institution
  • Kyiv, Ukraine, 03680
    • Local Institution
  • Lviv, Ukraine, 79010
    • Local Institution
  • Odesa, Ukraine, 65117
    • Local Institution
  • Ternopil, Ukraine, 46000
    • Local Institution
  • Vinnytsia, Ukraine, 21018
    • Local Institution
  • Zaporizhzhia, Ukraine, 69035
    • Local Institution
• United Kingdom
  • West Lothian
    • Livingston, West Lothian, United Kingdom, EH54 7BH
      • Local Institution
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35235
      • Alabama Clinical Therapeutics, LLC
    • Mobile, Alabama, United States, 36608
      • Horizon Research Group, Inc.
  • Arkansas
    • Fort Smith, Arkansas, United States, 72901
      • Fort Smith Lung Center
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences
  • California
    • Banning, California, United States, 92220
      • Beaver Medical Group
    • Fresno, California, United States, 93701
      • University of California San Francisco-Fresno
    • Sacramento, California, United States, 95817
      • University of California, Davis Medical Center
    • San Diego, California, United States, 92123
      • Chest Medicine & Critical Care Medical Gr. Inc.
    • Stanford, California, United States, 94305
      • Stanford University Medical Center
    • Torrance, California, United States, 90509
      • Harbor UCLA Medical Center
  • Colorado
    • Golden, Colorado, United States, 80401
      • New West Physicians
    • Wheat Ridge, Colorado, United States, 80033
      • Drogue Medical, Llc
  • Connecticut
    • Bridgeport, Connecticut, United States, 06610
      • Bridgeport Hospital
    • New Haven, Connecticut, United States, 06510
      • Dept Of Internal Med, Sect Of Pulmonary & Critical Care Med
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • George Washington University Medical Faculty Associates
  • Florida
    • Bay Pines, Florida, United States, 33744
      • Bay Pines Va Healthcare Systems
    • Brandon, Florida, United States, 33511
      • Daniel G. Lorch, Jr, Md, Cpi
    • Clearwater, Florida, United States, 33756
      • Research Alliance, Inc.
    • Jacksonville, Florida, United States, 32207
      • River City Clinical Research
    • St. Petersburg, Florida, United States, 33707
      • Pasadena Center for Medical Research
    • Tampa, Florida, United States, 33624
      • Tampa Clinical Research
    • Vero Beach, Florida, United States, 32960
      • Office Of Michele S. Maholtz Md
    • Weston, Florida, United States, 33331
      • Cleveland Clinic Florida
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Atlanta Pulmonary Group
    • Decatur, Georgia, United States, 30030
      • Atlanta Institute For Medical Research, Inc
    • Savannah, Georgia, United States, 31405
      • Chatham Hospitalists
  • Illinois
    • Jerseyville, Illinois, United States, 62052
      • Gateway Cardiology. P.C
    • Oak Park, Illinois, United States, 60302
      • West Suburban Medical Center
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Infectious Disease Of Indiana Psc
  • Iowa
    • Windsor Heights, Iowa, United States, 50324
      • Heartland Vascular Medicine and Surgery
  • Kentucky
    • Hazard, Kentucky, United States, 41701
      • Kentucky Lung Clinic
    • Lexington, Kentucky, United States, 40536
      • Univ. Of Kentucky Dept. Of Surgery
    • Owensboro, Kentucky, United States, 42303
      • Research Integrity, LLC
  • Maine
    • Rockport, Maine, United States, 04856
      • Pen Bay Medical Center
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Anne Arundel Medical Center
    • Baltimore, Maryland, United States, 21201
      • R Adams Cowley Shock Trauma Center
    • Baltimore, Maryland, United States, 21237
      • Medstar Research Health Institute
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Flint, Michigan, United States, 48503
      • Hurley Medical Center
  • Mississippi
    • Picayune, Mississippi, United States, 39466
      • Mississippi Medical Research, LLC
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri-Columbia
    • Kansas City, Missouri, United States, 64128
      • Veterans Affairs Medical Center
    • St Louis, Missouri, United States, 63110
      • Washington University School of Medicine
    • St. Louis, Missouri, United States, 63141
      • St. John's Mercy Medical Center
  • Montana
    • Butte, Montana, United States, 59701
      • Mercury Street Medical Group, PLLC
    • Great Falls, Montana, United States, 59405
      • Great Falls Clinic, LLP
  • Nebraska
    • Grand Island, Nebraska, United States, 68803
      • Internal Medical Associates Of Grand Island, P.C
    • Omaha, Nebraska, United States, 68131
      • Creighton University Medical Center
  • New Jersey
    • Morristown, New Jersey, United States, 07962
      • Morristown Memorial Hospital
  • New York
    • Albany, New York, United States, 12205
      • Pulmonary & Critical Care Services, Pc
    • Buffalo, New York, United States, 14209
      • Kaleida Health System
    • Staten Island, New York, United States, 10310
      • Richmond University Medical Center
    • Valhalla, New York, United States, 10595
      • New York Medical College
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Medical Center
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Raleigh, North Carolina, United States, 27607
      • Rex Healthcare
    • Statesville, North Carolina, United States, 28625
      • Piedmont Healthcare/Research
    • Wilmington, North Carolina, United States, 28401
      • Wilmington Medical Research
    • Winston Salem, North Carolina, United States, 27103
      • Clinical Trials of America, Inc.
  • North Dakota
    • Grand Forks, North Dakota, United States, 58201
      • Altru Health System Clinic
  • Ohio
    • Cleveland, Ohio, United States, 44112
      • Huron Hospital
    • Columbus, Ohio, United States, 43215
      • Remington Davis Inc.
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health Science University
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Medical Center
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Greenville Hospital System
    • Summerville, South Carolina, United States, 29485
      • Palmetto Clinical Research
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • Holston Medical Group
    • Jackson, Tennessee, United States, 38305
      • Kore CV Research
  • Texas
    • Houston, Texas, United States, 77024
      • PrimeCare Medical Group
    • San Antonio, Texas, United States, 78229
      • Cancer Care Centers of South Texas
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Medical Center
  • Washington
    • Bellevue, Washington, United States, 98004
      • Lake Washington Vascular, PLLC
    • Tacoma, Washington, United States, 98405
      • Franciscan Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Apixaban; apixaban: tablets, oral, 10 milligram (mg) tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months.	Drug: Enoxaparin; solution, subcutaneous, 1 mg/kg Q12h until International normalized ratio (INR) ≥2.; Drug: warfarin; tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months; Other Names: Coumadin; BMS-565793; Drug: Placebo for apixaban; tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months
Experimental: Enoxaparin + Warfarin; Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until international normalized ratio (INR) ≥2.	Drug: Placebo for enoxaparin; solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2.; Drug: Placebo for warfarin; tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months; Drug: apixaban; tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months; Other Names: BMS-562247

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or VTE-Related Death During 6 Months of Treatment	VTE: nonfatal deep vein thrombosis (DVT) or nonfatal pulmonary embolism (PE). All events were adjudicated by an ICAC blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants): n/N (n=number of participants with observation; N=total number of efficacy evaluable participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint: events at any time from randomization until end of intended treatment, regardless whether drug treatment was received. All randomized participants with a non-missing primary endpoint were summarized. Missing endpoint = outcomes which could not be documented on or after study Day 154. Participants were categorized to the assigned group regardless of the treatment actually received (intent-to-treat).	Day 1 to Week 24 + 2 Days or 355 days (Discontinued Early)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adjudicated Composite of Recurrent Symptomatic Venous Thromboembolism (VTE) or All-Cause Death	VTE included: nonfatal DVT or nonfatal PE. All events were adjudicated by an ICAC blinded to treatment. DVT was assessed by compression ultrasound and/or venography; PE was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of participants with observation; N=total number of efficacy evaluable participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received, ie intent to treat (ITT) principle. Each participant scored as having an event only if they experienced one or more of the elements of the composite. Participants with missing endpoint information excluded.	Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)
Incidence of Adjudicated Composite of Recurrent Symptomatic VTE or Cardiovascular (CV)-Related Death	VTE included: nonfatal DVT or nonfatal PE. All events were adjudicated by an ICAC blinded to treatment. DVT was assessed by compression ultrasound and/or venography; PE was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of participants with observation; N=total number of efficacy evaluable participants, participants with missing endpoint information excluded). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received, ie, ITT principle. Each participant scored as having an event only if the participant experienced one or more of the elements of the composite.	Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)
Incidence of Adjudicated Composite of Recurrent Symptomatic VTE or VTE-related Death or Major Bleeding	VTE included: nonfatal DVT or nonfatal PE. All events were adjudicated by an ICAC blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Major bleeding defined by International Society on Thrombosis and Haemostasis: acute, clinically overt bleeding associated with decrease in hemoglobin (Hgb) of 2 g/dL or more or bleeding leading to transfusion or bleeding in a critical site or bleeding that is fatal . Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint and including those not in the efficacy evaluable population with a bleeding event that occurred during treatment period. Events included regardless of whether or not participant received treatment, ie, ITT principle	Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)
Incidence of Adjudicated Composite of Recurrent Symptomatic VTE, Myocardial Infarction, Stroke, CV-related Death, Clinically Relevant Non-major (CRNM) Bleeding or Major Bleeding	VTE=Nonfatal DVT or nonfatal PE adjudicated by ICAC blinded to treatment. DVT: compression ultrasound and/or venography; PE: spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Major Bleeding = acute, clinically overt bleeding: decrease in Hgb of 2 g/dL or more or bleeding leading to transfusion or bleeding in a critical site or fatal bleeding. CRNM = acute clinically overt bleeding: compromising hemodynamics, leading to hospitalization, hematoma, epistasis >5 minutes or repetitive, gingival bleeding, hematuria, macroscopic gastrointestinal hemorrhage, rectal blood loss, hemoptysis. n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint and including those not in the efficacy evaluable population with a bleeding event that occurred during treatment period). Events included regardless of whether or not treatment was received (ITT).	Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)
Incidence of Adjudicated Symptomatic Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period	DVT adjudicated by an ICAC blinded to treatment. DVT evaluated by: compression ultrasound and/or venography. Includes events that occurred during the intended treatment period, regardless of whether the participant received study medication, intent to treat principle (ITT). Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early).	Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)
Incidence of Adjudicated Symptomatic Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period	PE adjudicated by an ICAC blinded to treatment. PE: spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Includes events that occurred during the intended treatment period, regardless of whether the participant received study medication (ITT principle). Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early).	Day 1 to Week 24 + + 2 Days or 355 Days (Discontinued Early)
Incidence of Adjudicated Venous Thromboembolism (VTE)-Related Death During the Intended Treatment Period	VTE-related death included: DVT-related death or PE-related death. All events were adjudicated by an ICAC blinded to treatment. DVT was assessed by compression ultrasound and/or venography; PE was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of participants with observation; N=total number of participants in respective treatment groups excluding participants with missing endpoint information). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Includes events that occur during the intended treatment period regardless of whether or not the participant received study medication (ITT principle).	Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Incidence of Cardiovascular (CV)-Related Death Including VTE-related Death During the Intended Treatment Period	VTE-related death included: DVT-related death or PE-related death. All events were adjudicated by an ICAC blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of participants with observation; N=total number of participants in respective treatment groups excluding participants with missing endpoint information). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Includes events that occur during the intended treatment period regardless of whether or not the participant received study medication (ITT principle).	Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Incidence of All-Cause Death During the Intended Treatment Period	Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Includes events that occurred during the intended treatment period, regardless of whether the participant received study medication (ITT principle). Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint information).	Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Incidence of Adjudicated Major Bleeding During the Treatment Period in Treated Participants	All events were adjudicated by an ICAC blinded to treatment. Bleeding defined by International Society on Thrombosis and Haemostasis: Major Bleeding: acute, clinically overt bleeding: decrease in hemoglobin (hgb) of 2 g/dL or more or bleeding leading to transfusion or bleeding in a critical site or fatal bleeding. Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants in respective treatment group (all participants who received at least one dose of study drug). Participants were categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to the treatment received.	Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Incidence of Adjudicated Major/CRNM Bleeding During the Treatment Period in Treated Participants	Major Bleeding = acute, clinically overt bleeding: decrease in hemoglobin of 2 g/dL or more, or bleeding leading to transfusion, or bleeding in a critical site, or fatal bleeding. CRNM = acute clinically overt bleeding: compromising hemodynamics, leading to hospitalization, hematoma, epistasis >5 minutes or repetitive, gingival bleeding, hematuria, macroscopic gastrointestinal hemorrhage, rectal blood loss, hemoptysis. Minor =: All acute clinically overt bleeding events not meeting the criteria for either major bleeding or CRNM. All events were adjudicated by an ICAC blinded to treatment. Total bleeding = any of major, or CRNM, or minor bleeding. Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of treated (received at least 1 dose of study drug).	Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Incidence of Adjudicated Clinically Relevant Non Major (CRNM) Bleeding During the Treatment Period in Treated Participants	Bleeding defined by International Society on Thrombosis and Haemostasis: CRNM defined as acute clinically overt bleeding: compromising hemodynamics, leading to hospitalization, hematoma, epistasis >5 minutes or repetitive, gingival bleeding, hematuria, macroscopic gastrointestinal hemorrhage, rectal blood loss, hemoptysis. All events were adjudicated by an ICAC blinded to treatment. Event rate (proportion of participants with event): calculated as n/N (n=number of participants with observation; N=Total number of participants in respective treatment group (all participants who received at least one dose of study drug). Participants were categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to the treatment received.	Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Incidence of Adjudicated Minor Bleeding During the Treatment Period in Treated Participants	Bleeding defined by International Society on Thrombosis and Haemostasis: Minor bleeding: all acute clinically overt bleeding events not meeting the criteria for either major bleeding or CRNM. All events wre adjudicated by an ICAC blinded to treatment. Event rate (proportion of participants) calculated as n/N (n=number of participants with observation; N=Total number of participants in respective treatment group (all participants who received at least one dose of study drug). Participants were categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to the treatment received.	Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Incidence of Adjudicated Total Bleeding During the Treatment Period in Treated Participants	Bleeding defined by International Society on Thrombosis and Haemostasis: Total Bleeding defined as any of major, CRNM, or minor bleeding. All events were adjudicated by an ICAC blinded to treatment. Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants in respective treatment group (all participants who received at least one dose of study drug). Participants were categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to the treatment received.	Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
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	Treated Participants: all who received at least 1 dose of study drug. Participants categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to treatment received. Included all SAEs and AEs with onset from first dose to last dose + 2 days (for AEs) or + 30 days (for SAEs); note; bleeding AEs and SAEs from first dose to last dose + 2 days included. Discontinuations due to AE included all AEs/SAEs from first dose until drug was discontinued. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.	First dose to last dose of 24 Weeks + 2 days (AEs) or + 30 days (SAEs) or until drug discontinued
Number of Treated Participants With Marked Abnormalities in Hematology Laboratory Tests	Lower limit of normal (LLN). Upper limit of normal (ULN). Pre-therapy (PreRx). Absolute (Abs) neutrophil count, bands + neutrophils (ANC). Cells per microliter (c/µL). Grams per deciliter (g/dL). Cells per Liter (c/L). Millimeter (MM). White blood cells: < 0.75*LLN, > 1.25*ULN; Hemoglobin: <= 11.5 g/dL (males), <= 9.5 g/dL (females); Hematocrit: <= 37% (males), <= 32% (females); Erythrocytes: <0.75*10^6 c/µL*PreRx; Platelet count: < 75*10^9 c/L, > 700*10^9 c/L; ANC: < 1.00*10^3 c/µL; Abs eosinophils: > 0.750*10^3 c/µL; Abs Basophils: > 400/MM^3; Abs Monocytes> 2000/MM^3; Abs Lymphocytes: < 0.750*10*3 c/ µL, > 7.5*10^3 c/ µL.	Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Number of Treated Participants With Marked Abnormalities in Electrolyte Laboratory Tests	Bicarbonate milliequivalents/Liter (mEq/L) Low/High: < 0.75*LLN or > 1.25*ULN, or if pre-dose < LLN then use < 0.75*pre-dose or > ULN if pre-dose > ULN then use > 1.25*pre-dose or < LLN; Serum Calcium mg/dL Low/High: < 0.8*LLN or > 1.2*ULN, or if pre-dose < LLN then use < 0.75*pre-dose or > ULN if pre-dose > ULN then use > 1.25*pre-dose or < LLN; Serum Chloride mEq/L: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use < 0.9*pre-dose or > ULN if pre-dose > ULN then use > 1.1*pre-dose or < LLN; Serum Potassium mEq/L: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use < 0.9*pre-dose or > ULN if pre-dose > ULN then use > 1.1*pre-dose or < LLN; Serum Sodium mEq/L: < 0.95*LLN or > 1.05*ULN, or if pre-dose < LLN then use < 0.95*pre-dose or > ULN if pre-dose > ULN then use > 1.05*pre-dose or < LLN.	Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Number of Treated Participants With Marked Abnormalities in Kidney and Liver Function Laboratory Tests	Blood urea nitrogen (BUN), milligrams/deciliter (mg/dL), units per liter (U/L). BUN mg/dL High: > 1.5*ULN; Creatinine mg/dL: > 1.5*ULN; Alanine aminotransferase (ALT) U/L: > 3*ULN; Aspartate aminotransferase (AST) U/L: > 3*ULN; Alkaline phosphatase U/L: > 2*ULN; Bilirubin Direct mg/dL: > 1.5*ULN; Bilirubin Total mg/dL: > 2*ULN.	Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Number of Treated Participants With Marked Abnormalities in Creatine Kinase, Uric Acid, and Total Protein Laboratory Tests	Creatine kinase High: >5*ULN Units/Liter (U/L); Total Protein High/Low: < 0.9 *LLN or > 1.1*ULN, or if pre-dose < LLN then use 0.9* pre-dose or > ULN if pre-dose > ULN then use 1.1 *pre-dose or <LLN; Uric acid High: > 1.5* ULN, or if pre-dose > ULN then use > 2 *pre-dose.	Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Number of Treated Participants With Marked Abnormalities in Urinalysis Laboratory Tests	All tests in urine: Glucose: If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4; Protein: If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4; Blood: If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4; Leukocyte esterase: If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4;Red blood cells (RBC): If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4; White blood cells (WBC): If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4.	Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Collaborators: Pfizer

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: Adv Ther. 2021 Aug;38(8):4596-4597.
• 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.
• 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.
• 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.

Helpful Links

• BMS clinical trial educational resource

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: March 20, 2008
• First Submitted That Met QC Criteria: March 20, 2008
• First Posted (Estimate): March 26, 2008

Study Record Updates

• Last Update Posted (Estimate): April 21, 2014
• Last Update Submitted That Met QC Criteria: April 17, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Thrombosis; Venous Thrombosis; Pulmonary Embolism; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Apixaban; Enoxaparin; Warfarin; Enoxaparin sodium
• Other Study ID Numbers: CV185-056; EUDRACT: 2007-007867-25