Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study (The APEX Study) (APEX)

August 3, 2023 updated by: Portola Pharmaceuticals

(Apex) Multicenter, Randomized, Active-Controlled Efficacy And Safety Study Comparing Extended Duration Betrixaban With Standard Of Care Enoxaparin For The Prevention Of Venous Thromboembolism In Acute Medically Ill Patients

The purpose of this study is to evaluate whether extended prophylaxis with oral betrixaban can prevent blood clots in the leg and lung that sometime occur in patients hospitalized for an acute medical illness and to compare these results with standard of care enoxaparin. The safety of betrixaban will also be studied.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7513

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1280
      • Ciudad Autónoma de Buenos Aires, Argentina, C1181ACH
      • Cordoba, Argentina, 5000
      • Coronel Suarez, Buenos Aires, Argentina, B7540DOL
      • Corrientes, Argentina, W3400AMZ
      • Córdoba, Argentina, 5000
      • El Talar, Argentina, 1618
      • Rosario, Santa Fe, Argentina, S2000DSV
      • San Miguel de Tucumán, Argentina, T4000JCU
  • Australia
      • Milton, Australia, Qld 4064
      • Parkville, Australia, Vic 3050
      • Randwick, Australia
      • Richmond, Australia, Vic 3121
    • Queensland
      • Redcliffe, Queensland, Australia, 4020
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
  • Austria
      • Feldkirch, Austria, 6800
      • Gratwein, Austria, 8112
      • Graz, Austria, 8036
      • Hartberg, Austria, 8230
      • Linz, Austria, 4020
      • Wien, Austria, 1100
      • Wien, Austria, 1160
      • Zams, Austria, 6511
  • Belgium
      • Bruxelles, Belgium, 1070
      • Huy, Belgium, 4500
      • Leper, Belgium, 8900
      • Leuven, Belgium, 3000
      • Yvoir, Belgium, 5530
  • Brazil
      • Belo Horizonte - MG, Brazil, 30150-221
      • Botucatu, Brazil, 18618-970
      • Brasilia, Brazil, 70710
      • Brasilia/DF, Brazil, 70710-905
      • Campinas, Brazil, 13083-970
      • Campinas, Sao Paulo, Brazil, 13059-740
      • Curitiba - PR, Brazil, 80030-001
      • Porto Alegre, Brazil, 90620-001
      • Porto Alegre, Brazil, 90880-480
      • Porto Alegre/RS, Brazil, 90620-001
      • Salvador, Brazil, 41810-011
      • Salvador/BA, Brazil, 40140-110
      • Salvador/BA, Brazil, 41810-011
      • Sao Paulo, Brazil, 04012-909
      • SãO Paulo, Brazil, 01323-903
      • São José Do Rio Preto- SP, Brazil, 15090-000
      • São Paulo, Brazil, 01308-050
  • Bulgaria
      • Gabrovo, Bulgaria, 5300
      • Pleven, Bulgaria, 5800
      • Plovdiv, Bulgaria, 4002
      • Sandanski, Bulgaria, 2800
      • Sliven, Bulgaria, 8800
      • Sofia, Bulgaria
      • Sofia, Bulgaria, 1784
      • Sofia, Bulgaria, 1233
      • Sofia, Bulgaria, 1606
      • Sofia, Bulgaria, 1202
      • Sofia, Bulgaria, 1407
      • Yambol, Bulgaria, 8600
  • Canada
      • Ontario, Canada, N8X 5A6
      • Quebec, Canada, G1V 4G5
    • Alberta
      • Edmonton, Alberta, Canada, T6K4B3
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton, Ontario, Canada, L8N 4A6
      • Kitchener, Ontario, Canada, N2M1B2
      • Ottawa, Ontario, Canada, K1H 8L6
      • Thunder Bay, Ontario, Canada, P7B 6R4
    • Quebec
      • Montreal, Quebec, Canada, H1T2M4
  • Chile
      • La Serena, Chile, 170000
      • Osorno, Chile
      • Santiago, Chile
      • Santiago, Chile, 7650568
      • Temuco, Chile, 4781173
      • Viña del Mar, Chile, 2570017
  • Croatia
      • Krapinske Toplice, Croatia, 49217
      • Pula, Croatia, 52100
      • Rijeka, Croatia, 51000
      • Varazdin, Croatia, 42000
      • Zadar, Croatia, 23000
      • Zagreb, Croatia, 10000
      • Zagreb, Croatia, 1000
  • Czechia
      • Caslav, Czechia, 286 01
      • Chrudim, Czechia, 537 27
      • Hradec Kralove, Czechia, 500 05
      • Kladno, Czechia, 272 01
      • Kromeriz, Czechia, 76701
      • Kyjov, Czechia, 697 33
      • Liberec, Czechia, 460 63
      • Litomysl, Czechia, 570 14
      • Olomouc, Czechia, 771 11
      • Ostrava, Czechia, 703 84
      • Plzen - Bory, Czechia, 305 99
      • Praha, Czechia, 128 08
      • Praha 1, Czechia, 110 00
      • Praha 1, Czechia, 118 00
      • Praha 10, Czechia, 100 34
      • Praha 5, Czechia, 150 06
      • Slany, Czechia, 274 01
      • Strakonice, Czechia, 386 29
      • Teplice, Czechia, 415 29
      • Usti nad Labem, Czechia, 401 13
      • Zlin, Czechia, 762 75
      • Znojmo, Czechia, 669 02
  • Denmark
      • Aarhus N, Denmark, DK-8200
      • Frederiksberg, Denmark, DK-2000
      • Glostrup, Denmark, DK-2600
      • Haderslev, Denmark, DK-6100
      • Hellerup, Denmark, DK-2900
      • Hillerod, Denmark, DK-3400
      • Hvidovre, Denmark, DK-2650
      • Kobenhavn NV, Denmark, DK-2400
      • Silkeborg, Denmark, DK-8600
      • Slagelse, Denmark, DK-4200
  • Estonia
      • Tallinn, Estonia, EE-13419
      • Tallinn, Estonia, EE-10138
      • Tartu, Estonia, EE-51014
  • Finland
      • Helsinki, Finland, FI-00290
      • Jyväskylä, Finland, FI-40620
      • Kouvola, Finland, FI-45750
      • Mikkeli, Finland, FI-50100
      • Pori, Finland, FI-28500
      • Tampere, Finland
      • Turku, Finland, FI-20520
  • France
      • Angers, France, 49100
      • Arras, France, 62022
      • Avignon, France, 84918
      • Bois-Guillaume, France, 76230
      • Bordeaux, France, 33075
      • Brest, France, 29609
      • Brest, France, 29200
      • Cambrai, France, 59400
      • Castelnau-le-Lez, France, 34170
      • Clermont-Ferrand, France, 63003
      • Colombes, France, 92700
      • Dijon, France, 21079
      • La Tronche, France, 38043
      • Le Mans, France, 72037
      • Lille, France, 59020
      • Limoges, France, 87 042
      • Montpellier, France, 34295
      • Nantes, France, 44093
      • Nimes, France, 30029 cedex 9
      • Paris, France, 75908
      • Paris, France, 75010
      • Paris, France, 75004
      • Pierre Benite, France, 69495
      • Quimper, France, 29107
      • Rennes, France, 35203
      • Saint-Priest En Jarrez, France, 42055
      • Tourcoing, France, 59200
      • Valenciennes, France, 59300
      • Vernon, France, 27207
  • Georgia
      • Tbilisi, Georgia, 0144
      • Tbilisi, Georgia, 0159
      • Tbilisi, Georgia, 0183
  • Germany
      • Altenburg, Germany, 04600
      • Bad Friedrichshall, Germany, 74173
      • Berlin, Germany, 10787
      • Bonn, Germany, 53115
      • Dresden, Germany, 01307
      • Dresden, Germany, 01067
      • Essen, Germany, 45147
      • Hamburg, Germany, 22559
      • Heidelberg, Germany, 69120
      • Karlbad, Germany, 76307
      • Ludwigshafen, Germany, 67063
      • Magdeburg, Germany, 39120
      • Mainz, Germany, 55131
      • Minden, Germany, 32429
      • Möchengladbach, Germany, 41063
      • Neuss, Germany, 41464
      • Oberhausen, Germany, 46045
      • Paderborn, Germany, 33098
      • Rüsselsheim, Germany, 65428
      • Troisdorf, Germany
      • Weiden, Germany, 92637
      • Wesel, Germany, 46483
      • Wiesbaden, Germany, 65199
      • Witten, Germany, 58455
  • Hungary
      • Baja, Hungary, 6500
      • Balassagyarmat, Hungary, 2660
      • Balatonfüred, Hungary, 8231
      • Berettyóújfalu, Hungary, 4100
      • Budapest, Hungary, 1125
      • Budapest, Hungary, 1122
      • Budapest, Hungary, 1145
      • Budapest, Hungary, 1097
      • Budapest,, Hungary, 1134
      • Cegléd, Hungary, 2700
      • Debrecen, Hungary, 4032
      • Debrecen, Hungary, H-4012
      • Eger, Hungary, 3300
      • Gyula, Hungary, 5700
      • Hódmezövásárhely, Hungary, 6800
      • Kistarcsa, Hungary, 2143
      • Mohács, Hungary, 7700
      • Nagykanizsa, Hungary, 8800
      • Szekszárd, Hungary, 7100
      • Szolnok, Hungary, 5000
      • Veszprém, Hungary, 8200
      • Zalaegerszeg, Hungary, 8900
  • Israel
      • Afula, Israel, 18101
      • Ashkelon, Israel, 78278
      • Haifa, Israel, 31048
      • Haifa, Israel, 31096
      • Jerusalem, Israel, 91120
      • Kfar Saba, Israel, 44281
      • Petach Tikva, Israel, 49100
      • Safed, Israel, 13100
      • Tel Aviv, Israel, 64239
      • Zerifin, Israel, 70300
  • Italy
      • Bollate, Italy, 20021
      • Frenze, Italy, 50134
      • Genova, Italy, 16128
      • Milano, Italy, 20132
      • Milano, Italy, 20085
      • Napoli, Italy, 80131
      • Parma, Italy, 43100
      • Pavia, Italy, 27100
      • Piacenza, Italy, 29121
      • Reggio Emilia, Italy, 42100
      • Roma, Italy, 00168
      • Varese, Italy, 21100
      • Venezia, Italy, 30122
      • Vittorio Veneto TV, Italy, 31029
    • Treviso
      • Castelfranco Veneto, Treviso, Italy, 31033
  • Latvia
      • Daugavpils, Latvia, LV-5417
      • Liepaja, Latvia, LV-3414
      • Riga, Latvia, LV-1002
      • Riga, Latvia, LV-1038
      • Valmiera, Latvia, LV-4201
  • Lithuania
      • Alytus, Lithuania, LT-62114
      • Kaunas, Lithuania, LT-47144
      • Kaunas, Lithuania, LT-44320
      • Kaunas, Lithuania, LT-45130
      • Klaipeda, Lithuania, LT-92231
      • Klaipeda, Lithuania, LT-92288
      • Siauliai, Lithuania, LT-76231
      • Utena, Lithuania, 28151
      • Vilnius, Lithuania, LT-04130
      • Vilnius, Lithuania, LT-10207
      • Vilnius, Lithuania, LT-08411
  • Montserrat
    • MS
      • Picayune, MS, Montserrat, 39466
  • Peru
      • Arequipa, Peru, 05154
      • Callao, Peru, CALLAO 2
      • Lima, Peru, 01
      • Lima, Peru, 18
      • Lima, Peru, Lima 11
      • Lima, Peru, LIMA 13
  • Poland
      • Bialystok, Poland, 15-276
      • Bydgoszcz, Poland, 85-681
      • Bydgoszcz, Poland, 85-168
      • Czeladz, Poland, 41-250
      • Gdansk, Poland, 80-803
      • Krakow, Poland, 31-121
      • Krakow, Poland, 31-913
      • Skierniewice, Poland, 96-100
      • Tarnobrzeg, Poland, 39-400
      • Warszawa, Poland, 01-138
      • Warszawa, Poland, 02-097
      • Wloclawek, Poland, 87-800
  • Romania
      • Baia, Romania, 430031
      • Bucharest, Romania, 022328
      • Bucharest, Romania, 021659
      • Bucharest, Romania, 020475
      • Bucharest, Romania, 041915
      • Cluj Napoca, Romania, 400006
      • Cluj-Napoca, Romania, 40001
      • Craiova, Romania, 200642
      • Iasi, Romania, 700620
      • Oradea, Romania, 410169
      • Pitesti, Romania, 110884
      • Targu Mures, Romania, 540136
      • Timisoara, Romania, 300736
  • Russian Federation
      • Arkhangelsk, Russian Federation, 163045
      • Barnaul, Russian Federation, 656045
      • Barnaul, Russian Federation, 656024
      • Belgorod, Russian Federation, 308007
      • Chelyabinsk, Russian Federation, 454048
      • Chelyabinsk, Russian Federation, 454091
      • Ekaterinburg, Russian Federation, 620039
      • Ekaterinburg, Russian Federation, 620219
      • Irkutsk, Russian Federation, 664049
      • Kaluga, Russian Federation, 428007
      • Kazan, Russian Federation, 420012
      • Kazan, Russian Federation, 420043
      • Kemerovo, Russian Federation, 650002
      • Kirov, Russian Federation, 610014
      • Krasnodar, Russian Federation, 350086
      • Lubertsy, Russian Federation, 140006
      • Moscow, Russian Federation, 119992
      • Moscow, Russian Federation, 111539
      • Moscow, Russian Federation, 121552
      • Moscow, Russian Federation, 119881
      • Moscow, Russian Federation, 117292
      • Moscow, Russian Federation, 127473
      • Murmansk, Russian Federation, 183047
      • Novosibirsk, Russian Federation, 630051
      • Novosibirsk, Russian Federation, 630054
      • Novosibirsk, Russian Federation, 630007
      • Rostov-on-Don, Russian Federation, 344022
      • Samara, Russian Federation, 443070
      • Saratov, Russian Federation, 410028
      • Saratov, Russian Federation, 410054
      • Saratov, Russian Federation, 410053
      • Smolensk, Russian Federation, 214018
      • St. Petersburg, Russian Federation, 197022
      • St. Petersburg, Russian Federation, 192242
      • St. Petersburg, Russian Federation, 196247
      • St. Petersburg, Russian Federation, 199106
      • St. Petersburg, Russian Federation, 195067
      • St. Petersburg, Russian Federation, 198205
      • St.Petersburg, Russian Federation, 191025
      • Tomsk, Russian Federation, 643012
      • Yaroslavl, Russian Federation, 150030
      • Yaroslavl, Russian Federation, 150003
  • Serbia
      • Belgrade, Serbia, 11000
      • Kragujevac, Serbia, 34000
      • Nis, Serbia, 18000
      • Niska Banja, Serbia, 18205
      • Pancevo, Serbia, 26000
      • Sremska Kamenica, Serbia, 21204
  • Singapore
      • Singapore, Singapore, 169608
      • Singapore, Singapore, 119074
      • Singapore, Singapore, 169609
  • Slovakia
      • Bratislava, Slovakia, 83305
      • Nitra, Slovakia, 94901
      • Nitra, Slovakia, 949 01
  • South Africa
      • Pretoria, South Africa, Gauteng 0084
      • Worcester, South Africa, 6850
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2193
      • Johannesburg, Gauteng, South Africa, 2021
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7530
  • Spain
      • Barcelona, Spain, 08041
      • Barcelona, Spain, 08023
      • Cartagena, Spain, 30202
      • Girona, Spain, 17007
      • Olot, Spain, 17800
      • Pontevedra, Spain, 36001
      • Salamanca, Spain, 37007
      • Terrassa, Spain, 08221
    • Cataluña
      • Barcelona, Cataluña, Spain, 08003
      • Barcelona, Cataluña, Spain, 08036
      • L'Hospitalet de Llobregat, Cataluña, Spain, 08907
      • Sabadell, Cataluña, Spain, 08208
      • Sant Boi de Llobregat, Cataluña, Spain, '08830
      • Tarragona, Cataluña, Spain, 43007
    • Communidad De
      • Madrid, Communidad De, Spain, 28007
    • Comunidad Valenciana
      • Orihuela, Comunidad Valenciana, Spain, 03314
    • Galicia
      • Vigo, Galicia, Spain, 36204
    • Madrid, Communidad De
      • Madrid, Madrid, Communidad De, Spain, 28034
      • Majadahonda, Madrid, Communidad De, Spain, 28222
      • San Sebastián de los Reyes, Madrid, Communidad De, Spain, 28702
  • Ukraine
      • Donetsk, Ukraine, 83114
      • Donetsk, Ukraine, 83045
      • Ivano-Frankivsk, Ukraine
      • Ivano-Frankivsk, Ukraine, 76008
      • Kharkiv, Ukraine, 61039
      • Kharkiv, Ukraine, 61176
      • Kharkiv, Ukraine, 61018
      • Kharkiv,, Ukraine, 61058
      • Kherson, Ukraine, 73039
      • Kirovograd, Ukraine, 25006
      • Kyiv, Ukraine, 02660
      • Kyiv, Ukraine, 02091
      • Kyiv, Ukraine, 01023
      • Kyiv, Ukraine, 03680
      • Kyiv, Ukraine, 04060
      • Lugansk, Ukraine, 91011
      • Lutsk, Ukraine, 43024
      • Lviv, Ukraine, 79010
      • Odesa, Ukraine, 65025
      • Odesa, Ukraine, 65014
      • Odesa, Ukraine, 65009
      • Rivne, Ukraine, 33001
      • Simferopol, Ukraine, 95026
      • Uzhgorod, Ukraine, 88000
      • Vinnytsya, Ukraine, 21005
      • Yevpatoriya, Ukraine, 97400
      • Zaporizhzhya, Ukraine, 69000
      • Zaporizhzhya, Ukraine, 69065
  • United Kingdom
      • London, United Kingdom, SE5 9RS
      • London, United Kingdom, EC1M 6BQ
      • London, United Kingdom, WC1E 6HX
      • Manchester, United Kingdom, M23 9LT
      • Newcastle Upon Tyne, United Kingdom, NE7 7DN
      • Romford, United Kingdom, RM7 0AG
      • Southall, United Kingdom, UB1 3HW
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
    • California
      • Bakersfield, California, United States, 93308
      • Fresno, California, United States, 93701
      • La Mesa, California, United States, 91942
      • Long Beach, California, United States, 90822
      • Los Angeles, California, United States, 90073
      • Modesto, California, United States, 95350
      • San Diego, California, United States, 92120
      • Stanford, California, United States, 94305
      • Torrance, California, United States, 90509
    • Colorado
      • Englewood, Colorado, United States, 80113
    • Florida
      • Bay Pines, Florida, United States, 33744
      • Clearwater, Florida, United States, 33756
      • Jacksonville, Florida, United States, 32216
      • Miami, Florida, United States, 33143
      • Pensacola, Florida, United States, 32504
      • Sarasota, Florida, United States, 34232
      • Vero Beach, Florida, United States, 32960
    • Georgia
      • Columbus, Georgia, United States, 31904
      • Decatur, Georgia, United States, 30030
    • Illinois
      • Chicago, Illinois, United States, 60611
      • Oak Park, Illinois, United States, 60302
    • Indiana
      • Carmel, Indiana, United States, 46032
    • Iowa
      • Davenport, Iowa, United States, 52803
      • Windsor Heights, Iowa, United States, 50324
    • Kansas
      • Topeka, Kansas, United States, 66604
    • Kentucky
      • Hazard, Kentucky, United States, 41701
    • Maryland
      • Annapolis, Maryland, United States, 21401
      • Baltimore, Maryland, United States, 21287
    • Michigan
      • Detroit, Michigan, United States, 48202
      • Grand Blanc, Michigan, United States, 48439
      • Royal Oak, Michigan, United States, 48073
      • Troy, Michigan, United States, 48085
    • Minnesota
      • Duluth, Minnesota, United States, 55805
    • Mississippi
      • Picayune, Mississippi, United States, 39466
    • Missouri
      • Kansas City, Missouri, United States, 64111
      • Saint Louis, Missouri, United States, 63110
    • Montana
      • Butte, Montana, United States, 59701
    • Nebraska
      • Omaha, Nebraska, United States, 68131
    • Nevada
      • Las Vegas, Nevada, United States, 89109
      • Reno, Nevada, United States, 89502
    • New Jersey
      • Atlantic City, New Jersey, United States, 08401
      • Pomona, New Jersey, United States, 08240
      • Somerville, New Jersey, United States, 08876
      • Summit, New Jersey, United States, 07901
    • New York
      • Buffalo, New York, United States, 14209
      • Manhasset, New York, United States, 11030
      • Staten Island, New York, United States, 10305
      • Valhalla, New York, United States, 10595
    • North Carolina
      • Durham, North Carolina, United States, 27710
    • Ohio
      • Cincinnati, Ohio, United States, 45267
      • Cleveland, Ohio, United States, 44106-5072
      • Columbus, Ohio, United States, 43210
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
      • Philadelphia, Pennsylvania, United States, 19107
    • South Carolina
      • Charleston, South Carolina, United States, 29425
      • Orangeburg, South Carolina, United States, 29118
    • Texas
      • Austin, Texas, United States, 78705
      • Austin, Texas, United States, 78752
      • Bellaire, Texas, United States, 77401
      • Corsicana, Texas, United States, 75110
      • Dallas, Texas, United States, 75216
      • Fort Worth, Texas, United States, 76104
      • Houston, Texas, United States, 77030
      • Houston, Texas, United States, 77024
      • McAllen, Texas, United States, 78501
      • Mission, Texas, United States, 78572
      • San Antonio, Texas, United States, 78258
      • San Antonio, Texas, United States, 78205
      • Victoria, Texas, United States, 77901
    • Vermont
      • Colchester, Vermont, United States, 05401
    • Virginia
      • Charlottesville, Virginia, United States, 22908
      • Richmond, Virginia, United States, 23249
    • Washington
      • Everett, Washington, United States, 98201
    • West Virginia
      • Huntington, West Virginia, United States, 25701

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • men and non-pregnant, non-breastfeeding women
  • anticipated to be severely immobilized for at least 24 hours after randomization

  • hospitalized with one of the following

    • congestive heart failure
    • acute respiratory failure,
    • acute infection without septic shock,
    • acute rheumatic disorders
    • acute ischemic stroke with lower extremity hemiparesis or hemi paralysis

Exclusion Criteria:

  • a condition requiring prolonged anticoagulation or anti-platelets
  • active bleeding or at high risk of bleeding
  • contraindication to anticoagulant therapy
  • general conditions in which subjects are not suitable to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Betrixaban
Daily oral (PO) betrixaban capsules for 35 to 42 days and subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days
Drug: Betrixaban

Betrixaban 80 mg PO once daily (QD) for 35 day + 7 days.

Enoxaparin Placebo: Once daily, 6-14 days
Active Comparator: Enoxaparin
Daily subcutaneous (SQ) injections of enoxaparin for 10 ± 4 days and oral (PO) betrixaban placebo capsules for 35 to 42 days
Drug: Enoxaparin

Enoxaparin 40 mg subcutaneous (SC) QD for 10 ± 4 days.

Betrixaban Placebo: once daily, 35 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Intent-to-Treat (mITT) Cohort 1: Percentage of Participants Experiencing the Composite Event of Symptomatic Deep Vein Thrombosis (DVT), Non-fatal Pulmonary Emboli (PE), VTE-related Death, or Asymptomatic Proximal DVT, Through Visit 3
Time Frame: mITT Cohort 1: Between randomization and Day 47 (max)
mITT Cohort 1: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, venous thromboembolism (VTE) related death adjudicated by a blinded independent Clinical Events Committee (CEC) between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3, or a blinded ultrasound core laboratory measuring of asymptomatic proximal DVT between randomization and Day 47. Visit 3 is between day 35-42 after randomization (day 1).
mITT Cohort 1: Between randomization and Day 47 (max)
mITT Cohort 2: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, VTE-related Death, or Asymptomatic Proximal DVT, Through Visit 3
Time Frame: mITT Cohort 2: Between randomization and Day 47 (max)
mITT Cohort 2: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3, or a blinded ultrasound core laboratory measuring of asymptomatic proximal DVT between randomization and Day 47. Visit 3 is between day 35-42 after randomization (day 1).
mITT Cohort 2: Between randomization and Day 47 (max)
mITT: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, VTE-related Death, or Asymptomatic Proximal DVT, Through Visit 3
Time Frame: mITT: Between randomization and Day 47 (max)
mITT: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3, or a blinded ultrasound core laboratory measuring of asymptomatic proximal DVT between randomization and Day 47. Visit 3 is between day 35-42 after randomization (day 1).
mITT: Between randomization and Day 47 (max)
Percentage of Participants Experiencing Major Bleeding Through Seven Days After Discontinuation of All Study Medication
Time Frame: Between randomization and Day 49 (max)
Percentage of participants experiencing at least one major bleeding adjudicated by a blinded independent CEC between randomization (day 1) and up to seven days after discontinuation of all study medication.
Between randomization and Day 49 (max)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mITT Cohort 1: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, or VTE-related Death, Through Visit 3
Time Frame: mITT Cohort 1: Between randomization and Day 42 (max)
mITT Cohort 1: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, or VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3. Visit 3 is between day 35-42 after randomization (day 1).
mITT Cohort 1: Between randomization and Day 42 (max)
mITT Cohort 2: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, or VTE-related Death, Through Visit 3
Time Frame: mITT Cohort 2: Between randomization and Day 42 (max)
mITT Cohort 2: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, or VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3. Visit 3 is between day 35-42 after randomization (day 1).
mITT Cohort 2: Between randomization and Day 42 (max)
mITT: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, or VTE-related Death, Through Visit 3
Time Frame: mITT: Between randomization and Day 42 (max)
mITT: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, or VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3. Visit 3 is between day 35-42 after randomization (day 1).
mITT: Between randomization and Day 42 (max)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Portola Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

April 16, 2012

First Submitted That Met QC Criteria

April 19, 2012

First Posted (Estimated)

April 23, 2012

Study Record Updates

Last Update Posted (Actual)

August 7, 2023

Last Update Submitted That Met QC Criteria

August 3, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-019

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Venous Thromboembolism (VTE)

Clinical Trials on Betrixaban

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe