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

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

The purpose is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients who have completed their intended treatment for deep vein thrombosis (DVT) or pulmonary embolism (PE)

Study Overview

• Status: Completed
• Conditions: Venous Thrombosis
• Intervention / Treatment: Drug: Apixaban; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 2711
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1280AEB
    • Local Institution
  • Buenos Aires, Argentina, C1122AAL
    • Local Institution
  • Buenos Aires, Argentina, C1431FWO
    • Local Institution
  • Cordoba, Argentina, 5000
    • Local Institution
  • Cordoba, Argentina, X5000JHQ
    • Local Institution
  • Corrientes, Argentina, 3400
    • Local Institution
  • Buenos Aires
    • Capital Federal, Buenos Aires, Argentina, C1426ANZ
      • Local Institution
    • Ciudad Autonoma De Buenos Aire, Buenos Aires, Argentina, 1093 AAS
      • Local Institution
    • Ciudad Autonoma De Buenos Aire, Buenos Aires, Argentina, C1180AAX
      • Local Institution
    • Ciudad Autonoma De Buenos Aire, Buenos Aires, Argentina, C1437JCP
      • Local Institution
    • Ciudad De Buenos Aires, Buenos Aires, Argentina, C1181ACH
      • Local Institution
    • Ciudad De Buenos Aires, Buenos Aires, Argentina, C1034ACO
      • Local Institution
    • Coronel Suarez, Buenos Aires, Argentina, B7540GHD
      • Local Institution
    • La Plata, Buenos Aires, Argentina, 1900
      • Local Institution
    • La Plata, Buenos Aires, Argentina, B1902COI
      • Local Institution
    • Mar Del Plata, Buenos Aires, Argentina, 7600
      • Local Institution
    • San Martin, Buenos Aires, Argentina, B1650CSQ
      • Local Institution
  • Santa Fe
    • Rosario, Santa Fe, Argentina, S2000CVB
      • Local Institution
    • Rosario, Santa Fe, Argentina, S2000DSV
      • Local Institution
    • Rosario, Santa Fe, Argentina, S2002KDS
      • Local Institution
• Australia
  • Australian Capital Territory
    • Garran, Australian Capital Territory, Australia, 2605
      • Local Institution
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • Local Institution
    • Lismore, New South Wales, Australia, 2480
      • Local Institution
    • St Leonards, New South Wales, Australia, 2065
      • Local Institution
  • Queensland
    • Herston, Queensland, Australia, 4029
      • Local Institution
    • Kippa Ring, Queensland, Australia, 4021
      • Local Institution
    • Woolloongabba, Queensland, Australia, 4102
      • Local Institution
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Local Institution
    • Bedford Park, South Australia, Australia, 5042
      • Local Institution
  • Tasmania
    • Launceston, Tasmania, Australia, 7250
      • Local Institution
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Local Institution
    • Clayton, Victoria, Australia, 3168
      • Local Institution
    • Footscray, Victoria, Australia, 3011
      • Local Institution
    • Parkville, Victoria, Australia, 3050
      • Local Institution
    • Richmond, Victoria, Australia, 3121
      • Local Institution
    • Ringwood East, Victoria, Australia, 3135
      • Local Institution
    • Windsor, Victoria, Australia, 3181
      • Local Institution
  • Western Australia
    • Perth, Western Australia, Australia, 6000
      • Local Institution
• Austria
  • Graz, Austria, 8036
    • Local Institution
  • Innsbruck, Austria, A-6020
    • Local Institution
  • Vienna, Austria, 1100
    • Local Institution
  • Vienna, Austria, 1090
    • Local Institution
  • Wien, Austria, 1090
    • Local Institution
  • Wien, Austria, 1140
    • Local Institution
• Brazil
  • Rio De Janeiro, Brazil, 20551
    • Local Institution
  • Sao Paulo, Brazil, 01323
    • Local Institution
  • Sao Paulo, Brazil, 01509
    • Local Institution
  • Sao Paulo, Brazil, 04005
    • Local Institution
  • Sao Paulo, Brazil, 05403
    • Local Institution
  • Bahia
    • Salvador, Bahia, Brazil, 40144 900
      • Local Institution
  • Distrito Federal
    • Brasilia, Distrito Federal, Brazil, 70335
      • Local Institution
  • Minas Gerais
    • Belo Horizonte - Mg, Minas Gerais, Brazil, 30130
      • Local Institution
    • Belo Horizonte - Mg, Minas Gerais, Brazil, 30150
      • Local Institution
  • Parana
    • Curitiba, Parana, Brazil, 80030
      • Local Institution
    • Curitiba, Parana, Brazil, 80050
      • Local Institution
    • Curitiba, Parana, Brazil, 80810
      • Local Institution
    • Curitiba, Parana, Brazil, 81520
      • 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, 9110270
      • Local Institution
  • Sao Paulo
    • Botucatu, Sao Paulo, Brazil, 18618
      • Local Institution
    • Campinas, Sao Paulo, Brazil, 13083
      • Local Institution
    • Santo Andre - Sp, Sao Paulo, Brazil, 09060
      • Local Institution
    • Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015
      • Local Institution
    • Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15090
      • Local Institution
• Canada
  • Quebec, Canada, G1V 4G5
    • Local Institution
  • Alberta
    • Edmonton, Alberta, Canada, T5H 4B9
      • Local Institution
    • Edmonton, Alberta, Canada, T5X 3N5
      • Local Institution
    • Edmonton, Alberta, Canada, TSA 4L8
      • Local Institution
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 9L8
      • Local Institution
    • Victoria, British Columbia, Canada, V8R 4R2
      • Local Institution
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Local Institution
    • Hamilton, Ontario, Canada, L8S 4K1
      • Local Institution
    • Toronto, Ontario, Canada, M5G 2C4
      • Local Institution
    • Waterloo, Ontario, Canada, N2J 1C4
      • Local Institution
    • Windsor, Ontario, Canada, N8X 5A6
      • Local Institution
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • Local Institution
    • Montreal, Quebec, Canada, H3G 1A4
      • Local Institution
    • Montreal, Quebec, Canada, H3T 1M5
      • Local Institution
    • Pointe- Claire, Quebec, Canada, H9R 3J1
      • Local Institution
    • St. Jerome, Quebec, Canada, J7Z 5T3
      • Local Institution
• Chile
  • Araucania
    • Temuco, Araucania, Chile, 4781173
      • Local Institution
  • 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
    • Santiago, Metropolitana, Chile, 7500520
      • Local Institution
    • Santiago, Metropolitana, Chile, 7980378
      • Local Institution
  • Valparaiso
    • Vina Del Mar, Valparaiso, Chile, 2520000
      • Local Institution
• Czech Republic
  • Kladno, Czech Republic, 272 59
    • Local Institution
  • Litomysl, Czech Republic, 570 14
    • Local Institution
  • Mestec Kralove, Czech Republic, 289 03
    • Local Institution
  • Ostrava Vitkovice, Czech Republic, 703 00
    • Local Institution
  • Plzen, Czech Republic, 323 33
    • Local Institution
  • Praha 1, Czech Republic, 110 00
    • Local Institution
  • Praha 1, Czech Republic, 118 33
    • Local Institution
  • Praha 13, Czech Republic, 158 00
    • Local Institution
  • Praha 2, Czech Republic, 128 08
    • Local Institution
  • Praha 2, Czech Republic, 120 00
    • Local Institution
  • Praha 2, Czech Republic, 121 11
    • Local Institution
  • Praha 4, Czech Republic, 140 21
    • Local Institution
  • Usti Nad Orlici, Czech Republic, 562 18
    • Local Institution
• Denmark
  • Arhus C, Denmark, 8000
    • Local Institution
  • Braedstrup, Denmark, 8740
    • Local Institution
  • Esbjerg, Denmark, 6700
    • Local Institution
  • Frederiksberg, Denmark, 2000
    • Local Institution
  • Hellerup, Denmark, 2900
    • Local Institution
  • Herning, Denmark, 7400
    • Local Institution
  • Hilleroed, Denmark, 3400
    • Local Institution
  • Naestved, Denmark, 4700
    • Local Institution
  • Silkeborg, Denmark, 8600
    • Local Institution
• France
  • Arras, France, 62022
    • Local Institution
  • Besancon, France, 25000
    • Local Institution
  • Brest Cedex, France, 29609
    • Local Institution
  • Clamart, France, 92141
    • Local Institution
  • Clermont-Ferrand Cedex 01, France, 63003
    • Local Institution
  • Dijon, France, 21079
    • Local Institution
  • Grenoble, France, 38043
    • Local Institution
  • Le Kremlin-Bicetre, France, 94275
    • Local Institution
  • Lille Cedex, France, 59020
    • Local Institution
  • Limoges Cedex, France, 87042
    • Local Institution
  • Lyon Cedex 03, France, 69437
    • Local Institution
  • Nantes, France, 44093
    • 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
  • Bochum, Germany, 44791
    • Local Institution
  • Bonn, Germany, 53115
    • Local Institution
  • Cologne, Germany, 50937
    • Local Institution
  • Dortmund, Germany, 44137
    • Local Institution
  • Dresden, Germany, 01307
    • Local Institution
  • Dresden, Germany, 01067
    • Local Institution
  • Erfurt, Germany, 99089
    • Local Institution
  • Frankfurt, Germany, 60596
    • Local Institution
  • Gottingen, Germany, 37075
    • Local Institution
  • Karlsbad, Germany, 76307
    • Local Institution
  • Krefeld, Germany, 47805
    • Local Institution
  • Ludwigshafen, Germany, 67063
    • Local Institution
  • Mannheim, Germany, 68161
    • Local Institution
  • Mannheim, Germany, 68165
    • Local Institution
  • Mannheim, Germany, 68167
    • Local Institution
  • Munchen, Germany, 80331
    • Local Institution
  • Munich, Germany, 80336
    • Local Institution
• Hong Kong
  • Hong Kong, Hong Kong
    • Local Institution
  • Shatin, N.T, Hong Kong
    • Local Institution
• India
  • Ahmedabad, India, 380015
    • Local Institution
  • Bangalore, India, 560052
    • Local Institution
  • Bangalore, Karnataka, India, 560034
    • Local Institution
  • Chennai, India, 600 003
    • Local Institution
  • Chennai, India, 600 006
    • Local Institution
  • New Dehli, India, 110025
    • 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
  • Kerala
    • Kochi, Kerala, India, 682041
      • 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
  • Givataim, Israel, 53488
    • Local Institution
  • Hadera, Israel, 38101
    • Local Institution
  • Haifa, Israel, 31096
    • Local Institution
  • Haifa, Israel, 31048
    • Local Institution
  • Holon, Israel, 58100
    • Local Institution
  • Jerusalem, Israel, 91031
    • Local Institution
  • Kfar Saba, Israel, 44281
    • Local Institution
  • Kiryat Hadassah, Israel, 91120
    • Local Institution
  • Nahariya, Israel, 22100
    • Local Institution
  • Petach-Tikva, Israel, 49100
    • Local Institution
  • Safed, Israel, 13100
    • Local Institution
  • Tel Aviv, Israel, 64239
    • Local Institution
  • Tel Hashomer, Israel, 52621
    • Local Institution
• Italy
  • Bollate, Italy, 20021
    • Local Institution
  • Bologna, Italy, 40138
    • Local Institution
  • Chieti Scalo, Italy, 66013
    • Local Institution
  • Cosenza, Italy, 87100
    • Local Institution
  • Ferrara, Italy, 44100
    • Local Institution
  • Firenze, Italy, 50134
    • Local Institution
  • Genova, Italy, 16128
    • Local Institution
  • Milano, Italy, 20132
    • Local Institution
  • Padova, Italy, 35128
    • Local Institution
  • Palermo, Italy, 90127
    • Local Institution
  • Pavia, Italy, 27100
    • Local Institution
  • Perugia, Italy, 06132
    • Local Institution
  • Piacenza, Italy, 29100
    • Local Institution
  • Pisa, Italy, 56124
    • Local Institution
  • Roma, Italy, 00168
    • Local Institution
  • Rozzano (Mi), Italy, 20089
    • Local Institution
  • San Daniele Del Friuli (Ud), Italy, 33038
    • Local Institution
  • Udine, Italy, 33100
    • Local Institution
  • Venezia, Italy, 30122
    • 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
  • Jongno-Gu, Korea, Republic of, 110-774
    • Local Institution
  • Seoul, Korea, Republic of, 135-710
    • Local Institution
  • Seoul, Korea, Republic of, 137-040
    • Local Institution
  • Seoul, Korea, Republic of, 120752
    • Local Institution
  • Seoul, Korea, Republic of, 138736
    • Local Institution
• Mexico
  • Aguascalientes, Mexico, 20230
    • Local Institution
  • Chihuahua, Mexico, 31203
    • Local Institution
  • Durango, Mexico, 34080
    • Local Institution
  • Puebla, Mexico, 72000
    • Local Institution
  • Queretaro, Mexico, 76000
    • Local Institution
  • San Luis Potosi, Mexico, 78240
    • Local Institution
  • San Luis Potosi, Mexico, 78200
    • Local Institution
  • Baja California
    • Tijuana, Baja California, Mexico, 22500
      • Local Institution
  • Distrito Federal
    • Mexico, Distrito Federal, Mexico, 06726
      • Local Institution
  • Guanajuato
    • Leon, Guanajuato, Mexico, 37320
      • Local Institution
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44280
      • Local Institution
    • Guadalajara, Jalisco, Mexico, 44130
      • Local Institution
    • Guadalajara, Jalisco, Mexico, 44200
      • Local Institution
    • Zapopan, Jalisco, Mexico, 45200
      • Local Institution
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64710
      • Local Institution
    • Monterrey, Nuevo Leon, Mexico, 64000
      • Local Institution
  • Sinaloa
    • Culiacan, Sinaloa, Mexico, 80020
      • Local Institution
    • Culiacan, Sinaloa, Mexico, 80230
      • Local Institution
  • Veracruz
    • Xalapa, Veracruz, Mexico, 91020
      • Local Institution
• Norway
  • Alesund, Norway, 6026
    • 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
• Philippines
  • Cavite, Philippines, 4114
    • Local Institution
  • Davao City, Philippines, 8000
    • Local Institution
  • Pasig City, Philippines, 1600
    • Local Institution
  • Quezon City, Philippines, 1102
    • Local Institution
• Poland
  • Arkonska 4, Poland, 71455
    • Local Institution
  • Bialystok, Poland, 15-276
    • Local Institution
  • Bydgoszcz, Poland, 85-168
    • Local Institution
  • Bydgoszcz, Poland, 85-650
    • Local Institution
  • Bydgoszcz, Poland, 85-681
    • Local Institution
  • Gdansk, Poland, 80-803
    • Local Institution
  • Gdynia, Poland, 81-348
    • Local Institution
  • Gdynia, Poland, 81-423
    • 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
  • Tarnobrzeg, Poland, 39-400
    • Local Institution
  • Warsaw, Poland, 01-809
    • Local Institution
  • Warsaw, Poland, 02-005
    • Local Institution
  • Warsawa, Poland, 02-776
    • Local Institution
  • Warszawa, Poland, 01-138
    • Local Institution
  • Warszawa, Poland, 02-018
    • Local Institution
  • Wroclaw, Poland, 51-124
    • Local Institution
  • Wroclaw, Poland, 53-114
    • Local Institution
• Portugal
  • Guarda, Portugal, 6301-857
    • Local Institution
  • Lisboa, Portugal, 1769-001
    • Local Institution
• Puerto Rico
  • San Juan, Puerto Rico, 00909
    • Local Institution
  • 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
  • Kemerovo, Russian Federation, 650002
    • Local Institution
  • Moscow, Russian Federation, 105077
    • Local Institution
  • Moscow, Russian Federation, 111539
    • Local Institution
  • Moscow, Russian Federation, 119049
    • Local Institution
  • Moscow, Russian Federation, 127473
    • Local Institution
  • Novosibirsk, Russian Federation, 630055
    • 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, 196247
    • Local Institution
  • Saint-Petersburg, Russian Federation, 199106
    • Local Institution
  • Samara, Russian Federation, 443010
    • Local Institution
  • Saratov, Russian Federation, 410012
    • Local Institution
  • Saratov, Russian Federation, 410028
    • Local Institution
  • St Petersburg, Russian Federation, 194044
    • Local Institution
  • Tomsk, Russian Federation, 634012
    • Local Institution
  • Yaroslavl, Russian Federation, 150062
    • Local Institution
• Singapore
  • Singapore, Singapore, 308433
    • Local Institution
  • Singapore, Singapore, 169608
    • Local Institution
• South Africa
  • Free State
    • Bloemfontein, 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, 0083
      • 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
  • Cadiz, Spain, 11009
    • Local Institution
  • Getafe, Spain, 28905
    • Local Institution
  • Girona, Spain, 17007
    • 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, 28040
    • Local Institution
  • Madrid, Spain, 28029
    • Local Institution
  • Mourente, Spain, 36071
    • Local Institution
  • Pamplona, Spain, 31008
    • Local Institution
  • Salamanca, Spain, 37007
    • Local Institution
  • Sant Boi De Llobregat, Spain, 08830
    • Local Institution
  • Tarragona, Spain, 43007
    • Local Institution
  • Toledo, Spain, 45071
    • Local Institution
  • Valencia, Spain, 46026
    • Local Institution
  • Alicante
    • Torrevieja, Alicante, Spain, 03186
      • Local Institution
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Local Institution
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Local Institution
    • San Sebastian De Los Reyes, Madrid, Spain, 28702
      • 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
  • Aberdeenshire
    • Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZN
      • Local Institution
  • Essex
    • Romford, Essex, United Kingdom, RM7 0AG
      • Local Institution
  • Greater London
    • London, Greater London, United Kingdom, SE5 9RS
      • Local Institution
    • London, Greater London, United Kingdom, SW17 0QT
      • Local Institution
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M23 9LT
      • Local Institution
  • Humberside
    • Hull, Humberside, United Kingdom, HU3 2JZ
      • Local Institution
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
      • Local Institution
  • Suffolk
    • Bury St. Edmunds, Suffolk, United Kingdom, IP30 9QU
      • Local Institution
  • West Midlands
    • Coventry, West Midlands, United Kingdom, CV2 2DX
      • Local Institution
    • Dudley, West Midlands, United Kingdom, DY1 2HQ
      • Local Institution
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35235
      • Alabama Clinical Therapeutics, LLC
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Cardiovascular Consultants, Ltd.
    • Tempe, Arizona, United States, 85283
      • Robert J. Bloomberg, Md, Pc
  • Arkansas
    • Fort Smith, Arkansas, United States, 72901
      • Fort Smith Lung Center
  • California
    • Banning, California, United States, 92220
      • Beaver Medical Group
    • La Jolla, California, United States, 92037
      • Scripps Clinic/Scripps Health And Green Hospital
    • Los Angeles, California, United States, 90015
      • HealthCare Partners Medical Group
    • Mission Viejo, California, United States, 92691
      • Mission Internal Medical Group
    • Palm Springs, California, United States, 92262
      • Desert Med Grp Inc, Dba Desert Oasis Healthcare Med Group
    • Pomona, California, United States, 91767
      • Indus Clinical Research Institute, Inc.
    • San Francisco, California, United States, 94118
      • Kaiser Permanente Medical Center
    • Stanford, California, United States, 94305
      • Stanford University Medical Center
    • Torrance, California, United States, 90509
      • Harbor UCLA Medical Center
    • Vista, California, United States, 92083
      • Progressive Clinical Research
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Rocky Mountain Internal Medicine
    • Golden, Colorado, United States, 80401
      • New West Physicians
  • Delaware
    • Newark, Delaware, United States, 19713
      • Alfieri Cardiology
  • Florida
    • Bay Pines, Florida, United States, 33744
      • Bay Pines Va Healthcare Systems
    • Clearwater, Florida, United States, 33756
      • Research Alliance, Inc.
    • Clearwater, Florida, United States, 33765
      • St. Francis Sleep Allergy & Lung Institute
    • Fort Lauderdale, Florida, United States, 33316
      • Berma Research Group
    • Hollywood, Florida, United States, 33021
      • Healthworx
    • Loxahatchee, Florida, United States, 33470
      • Hematology Oncology Associates
    • Miami, Florida, United States, 33143
      • South Miami Heart Center
    • Naples, Florida, United States, 34119
      • Physicians Regional Medical Group
    • Plantation, Florida, United States, 33317
      • Richard A. Mclean M.D., P.A.
    • Tampa, Florida, United States, 33624
      • Tampa Clinical Research
    • Vero Beach, Florida, United States, 32960
      • Primary Care Of The Treasure Coast, Inc.
    • Weston, Florida, United States, 33331
      • Cleveland Clinic Florida
  • Georgia
    • Austell, Georgia, United States, 30106
      • Vascular Surgical Associates, PC
    • Decatur, Georgia, United States, 30030
      • Atlanta Institute For Medical Research, Inc
    • Lawrenceville, Georgia, United States, 30046
      • Gwinnett Biomedical Research
  • Idaho
    • Boise, Idaho, United States, 83706
      • Boise Orthopedic Clinic
    • Nampa, Idaho, United States, 83686
      • Saltzer Medical Group
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Infectious Disease Of Indiana Psc
    • New Albany, Indiana, United States, 47150
      • Office Of:Eugene C. Fletcher, Md
  • Iowa
    • Windsor Heights, Iowa, United States, 50324
      • Heartland Vascular Medicine and Surgery
  • Kentucky
    • Hazard, Kentucky, United States, 41701
      • Kentucky Lung Clinic
    • Owensboro, Kentucky, United States, 42303
      • Owensboro Heart & Vascular
  • Maine
    • Rockport, Maine, United States, 04856
      • Pen Bay Medical Center
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Anne Arundel Health System Research Institute, Inc.
  • Massachusetts
    • Hyannis, Massachusetts, United States, 02601
      • Cape Cod Research Institute
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital
  • Missouri
    • Kansas City, Missouri, United States, 64128
      • Veterans Affairs 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 York
    • Buffalo, New York, United States, 14209
      • Kaleida Health System
    • Goshen, New York, United States, 10924
      • Goshen Medical Associates
    • Liverpool, New York, United States, 13088
      • SJH Cardiology Associates
    • Staten Island, New York, United States, 10310
      • Richmond University Medical Center
    • Valhalla, New York, United States, 10595
      • New York Medical College
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Thomas L. Ortel, Md, Phd
    • Fayetteville, North Carolina, United States, 28304
      • Valley Internal Medicine
    • Raleigh, North Carolina, United States, 27607
      • Rex Healthcare
    • Statesville, North Carolina, United States, 28625
      • Piedmont Healthcare/Research
    • Whiteville, North Carolina, United States, 28472
      • Whiteville Medical Associates, P.A.
    • Wilmington, North Carolina, United States, 28401
      • Wilmington Medical Research
  • Ohio
    • Akron, Ohio, United States, 44307
      • Akron General Medical Center
    • Canal Fulton, Ohio, United States, 44614
      • Community Health Care, Inc.
    • Centerville, Ohio, United States, 45459
      • Valley Medical Research
    • Columbus, Ohio, United States, 43210
      • Ohio State University Medical Center
    • Columbus, Ohio, United States, 43215
      • Remington Davis Inc.
    • Toledo, Ohio, United States, 43606
      • Jobst Vascular Center At The Toledo Hospital
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • COR Clinical Research, LLC
  • Pennsylvania
    • Phoenixville, Pennsylvania, United States, 19460
      • PMA Medical Specialists
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Charleston Hematology Oncology Associates, PA
    • Greenville, South Carolina, United States, 29615
      • Greenville Hospital System
    • Irmo, South Carolina, United States, 29063
      • Three Rivers Medical Associates, Pa
    • Murrells Inlet, South Carolina, United States, 29576
      • Clinical Research Authority, Llc
    • Summerville, South Carolina, United States, 29485
      • Palmetto Clinical Research
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • Holston Medical Group
    • Kingsport, Tennessee, United States, 37660
      • Holston Medical Group
  • Texas
    • Amarillo, Texas, United States, 79106
      • Amarillo Heart Clinical Research Institute Inc.
    • Corsicana, Texas, United States, 75110
      • Corsicana Medical Research
    • Houston, Texas, United States, 77024
      • Ankur Doshi, Md
    • Tomball, Texas, United States, 77375
      • Northwest Heart Center
  • Utah
    • Layton, Utah, United States, 84041
      • Tanner Clinic
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Hospital
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Health System
    • Norfolk, Virginia, United States, 23510
      • Sentara York Clinical Research
  • Washington
    • Bellevue, Washington, United States, 98004
      • Lake Washington Vascular, PLLC
    • Tacoma, Washington, United States, 98405
      • Franciscan Research Center
  • Wisconsin
    • Menomonee Falls, Wisconsin, United States, 53051
      • Medical Assoicates Inc.

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 Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE);
• Anticoagulant treatment completed
• No recurrence of Venous Thromboembolism (VTE)

Exclusion Criteria:

• Subjects with indications for long-term treatment with a vitamin K antagonist
• Active bleeding or high risk for serious bleeding
• Short life expectancy
• Uncontrolled high blood pressure
• 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

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; 2.5 mg	Drug: Apixaban; Tablets, Oral, twice daily, 12 months; Other Names: BMS-562247
Experimental: 2; 5.0 mg	Drug: Apixaban; Tablets, Oral, twice daily, 12 months; Other Names: BMS-562247
Active Comparator: 3; 0 mg	Drug: Placebo; Tablets, Oral, twice daily, 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation	VTE included: nonfatal deep vein thrombosis (DVT) or nonfatal pulmonary embolism (PE). All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee 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 events; N=number of 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. For missing endpoint data, participants were imputed as having had a primary efficacy outcome event.	Day 1 up to 12 Months
Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation	VTE included: nonfatal DVT or nonfatal PE. Event rate (proportion of participants with event) calculated as n/N (n=number of events; N=number of 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. No imputation was done for these endpoints; participants who had an event during the intended treatment period were counted. Confidence interval (CI) for single event rate was calculated based on the Wald asymptotic confidence limits.	Day 1 up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or VTE-related Death During the Intended Treatment Period - Randomized Population With Imputation	VTE includes nonfatal DVT or nonfatal PE. All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee 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 events; N=number of 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. For missing endpoint data, participants were imputed as having had a primary efficacy outcome event.	Day 1 up to 12 Months
Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Cardio Vascular (CV) -Related Death During the Intended Treatment Period - Randomized Population With Imputation	VTE includes nonfatal DVT or nonfatal PE. All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee 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 is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Composite endpoint included events that occurred any time from randomization until end of the intended treatment period, regardless of whether the participants were receiving drug treatment. Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. If there were missing endpoint data, participants were imputed as having had an efficacy outcome event.	Day 1 up to 12 Months
Adjudicated Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period - Randomized Population With Imputation	DVT was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and assessed by compression ultrasound and/or venography. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. Participants with missing endpoint information were classified as having had the efficacy event (imputation). Confidence interval (CI) for single event rate was calculated based on the Wald asymptotic confidence limits.	Day 1 up to 12 Months
Adjudicated Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period - Randomized Population With Imputation	PE was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. Participants with missing endpoint information were classified as having had the efficacy event (imputation). CI for single event rate was calculated based on the Wald asymptotic confidence limits.	Day 1 up to 12 Months
Adjudicated Venous Thromboembolism (VTE) - Related Death During the Intended Treatment Period - Randomized Population With Imputation	VTE-related death defined as: PE (based on objective diagnostic testing, autopsy), unexplained death (and VTE cannot be ruled out), sudden death (and VTE cannot be ruled out). DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee 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. New/recurrent VTE, death, venous/arterial thromboembolic events, bleeding, thrombocytopenia, acute myocardial infarction and stroke were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Participants with missing endpoint information were classified as having had the efficacy event (imputation).	Day 1 up to 12 Months
Adjudicated Cardiovascular (CV)-Related Death During the Intended Treatment Period - Randomized Population With Imputation	CV-related death was defined as myocardial infarction, stroke, or other specified cardiovascular event and were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. Participants with missing endpoint information were classified as having had the efficacy event (imputation). CI for single event rate was calculated based on the Wald asymptotic confidence limits.	Day 1 up to 12 Months
Adjudicated All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation	DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee 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. New/recurrent VTE, death, venous/arterial thromboembolic events, bleeding, thrombocytopenia, acute myocardial infarction and stroke were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Participants with missing endpoint information were classified as having had the efficacy event (imputation). CI for single event rate was calculated based on the Wald asymptotic confidence limits.	Day 1 up to 12 Months
Number of Participants With an Adjudicated Symptomatic Nonfatal Venous Thromboembolism (VTE) Recurrence or Death (All Cause) During the Intended Treatment Period - Randomized Participants Without Imputation	All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee 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. Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. First event category was the first primary event for each participant and each participant was counted once. CV-related death was presented excluding VTE-related death. In participants with event category, each participant was counted once in each event category but could have been counted in multiple categories. No imputation was done for these endpoints; participants who had an event during the intended treatment period were counted.	Day 1 up to 12 Months
Adjudicated Major Bleeding During the Treatment Period - Treated Population	Major bleeding was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and was defined as acute clinically overt bleeding: associated with a fall in hemoglobin of 2 grams per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 milliliters (mL) or more of whole blood, or in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or another critical organ; or is fatal. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Confidence interval (CI) for event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.	Day 1 up to 12 Months
Adjudicated Composite of Major/Clinically Relevant Non-major Bleeding During the Treatment Period - Treated Participants	Major bleeding and clinically relevant non-major bleeding were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Major bleeding was defined as acute clinically overt bleeding: associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 mL or more of whole blood, or in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or another critical organ or is fatal. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). CI for single event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.	Day 1 up to 12 Months
Adjudicated Clinically Relevant Non-major Bleeding During the Treatment Period - Treated Participants	Non-major clinically relevant bleeding was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and defined as: acute clinically overt bleeding compromising hemodynamics; leading to hospitalization; traumatic subcutaneous hematoma; intramuscular hematoma; epistaxis that lasted for more than 5 minutes, was repetitive or led to an intervention; spontaneous gingival bleeding (or lasting more than 5 minutes); spontaneous hematuria (macroscopic or lasted more than 24 hours after instrumentation of the urogenital tract); macroscopic gastrointestinal hemorrhage (including at least 1 episode of melena or hematemesis (if clinically apparent with positive results on a fecal occult-blood test); rectal blood loss. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). CI for single event rate was calculated based on the Wald asymptotic confidence limits.	Day 1 up to 12 months
Adjudicated Clinically Relevant Minor Bleeding During the Treatment Period - Treated Participants	All bleeding events were reviewed by the central independent adjudication committee blinded to treatment and classified as major bleeding, clinically relevant non-major bleeding, minor bleeding or no bleeding. If event was not major or clinically relevant non-major, it was judged to be minor. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Confidence interval (CI) for single event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.	Day 1 up to 12 months
Adjudicated Total Bleeding During the Treatment Period - Treated Participants	All bleeding events were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Total bleeding was defined as any major, clinically relevant non-major, or minor bleeding. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). CI for single event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.	Day 1 up to 12 months
Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Venous Thromboembolism-related Death During the Intended Treatment Period - Randomized Population Without Imputation	VTE related death defined as PE (based on objective diagnostic testing, autopsy), unexplained death (and VTE cannot be ruled out), sudden death (and VTE cannot be ruled out). DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee 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. New/recurrent VTE and death, were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for these endpoints.	Day 1 up to 12 Months
Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Cardio Vascular (CV) - Related Death During the Intended Treatment Period - Randomized Population Without Imputation	CV-related death was defined as myocardial infarction, stroke, or other specified cardiovascular event. Index events of DVT and/or PE, along with myocardial infarction and stroke were adjudicated/confirmed by a central independent adjudication committee 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 is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for these endpoints; participants who had an event during the intended treatment period were counted.	Day 1 up to 12 Months
Adjudicated Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period - Randomized Population Without Imputation	DVT was adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.	Day 1 up to 12 Months
Adjudicated Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period - Randomized Population Without Imputation	PE was adjudicated/confirmed by a central independent adjudication committee blinded to treatment: PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.	Day 1 up to 12 Months
Adjudicated Venous Thromboembolism (VTE)- Related Death During the Intended Treatment Period - Randomized Population Without Imputation	VTE related death defined as PE (based on objective diagnostic testing, autopsy), unexplained death (and VTE cannot be ruled out), sudden death (and VTE cannot be ruled out). DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee 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. New/recurrent VTE, and death, were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint.	Day 1 up to 12 Months
Adjudicated Cardio Vascular (CV)-Related Death During the Intended Treatment Period - Randomized Population Without Imputation	CV-related death was defined as myocardial infarction, stroke, or other specified cardiovascular event and these were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.	Day 1 up to 12 Months
Adjudicated All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation	DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee 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. New/recurrent VTE, death, venous/arterial thromboembolic events, bleeding, thrombocytopenia, acute myocardial infarction and stroke were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.	Day 1 up to 12 Months

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.
• Liu X, Thompson J, Phatak H, Mardekian J, Porcari A, Johnson M, Cohen AT. Extended anticoagulation with apixaban reduces hospitalisations in patients with venous thromboembolism. An analysis of the AMPLIFY-EXT trial. Thromb Haemost. 2016 Jan;115(1):161-8. doi: 10.1160/TH15-07-0606. Epub 2015 Oct 8.
• Agnelli G, Buller HR, Cohen A, Curto M, Gallus AS, Johnson M, Porcari A, Raskob GE, Weitz JI; AMPLIFY-EXT Investigators. Apixaban for extended treatment of venous thromboembolism. N Engl J Med. 2013 Feb 21;368(8):699-708. doi: 10.1056/NEJMoa1207541. Epub 2012 Dec 8.

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: March 5, 2008
• First Submitted That Met QC Criteria: March 5, 2008
• First Posted (Estimate): March 12, 2008

Study Record Updates

• Last Update Posted (Estimate): November 25, 2013
• Last Update Submitted That Met QC Criteria: October 30, 2013
• Last Verified: October 1, 2013

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; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Apixaban
• Other Study ID Numbers: CV185-057; EUDRACT: 2007-004953-27