Trial record 1 of 1 for:    VTE 11-019
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Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study (The APEX Study)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Portola Pharmaceuticals Identifier:
First received: April 16, 2012
Last updated: November 3, 2015
Last verified: October 2015
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.

Condition Intervention Phase
Venous Thromboembolism (VTE)
Drug: Betrixaban
Drug: Enoxaparin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: (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

Resource links provided by NLM:

Further study details as provided by Portola Pharmaceuticals:

Primary Outcome Measures:
  • Composite of VTE (DVT and/or PE) and VTE Death [ Time Frame: Occurrence of any of the events through the Day 35 visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients with symptomatic VTE [ Time Frame: The occurrence through the Day 35 visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 7500
Study Start Date: March 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Betrixaban Drug: Betrixaban

Betrixaban 80 mg PO QD for 35 day + 7 days.

Enoxaparin Placebo: Once daily, 6-14 days

Active Comparator: Enoxaparin Drug: Enoxaparin

Enoxaparin 40 mg SC QD for 10 ± 4 days.

Betrixaban Placebo: once daily, 35 days


Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01583218

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United States, Alabama
Birmingham, Alabama, United States, 35294
United States, 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
United States, Colorado
Englewood, Colorado, United States, 80113
United States, 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
United States, Georgia
Columbus, Georgia, United States, 31904
Decatur, Georgia, United States, 30030
United States, Illinois
Chicago, Illinois, United States, 60611
Oak Park, Illinois, United States, 60302
United States, Indiana
Carmel, Indiana, United States, 46032
United States, Iowa
Davenport, Iowa, United States, 52803
Windsor Heights, Iowa, United States, 50324
United States, Kansas
Topeka, Kansas, United States, 66604
United States, Kentucky
Hazard, Kentucky, United States, 41701
United States, Maryland
Annapolis, Maryland, United States, 21401
Baltimore, Maryland, United States, 21287
United States, Michigan
Detroit, Michigan, United States, 48202
Grand Blanc, Michigan, United States, 48439
Royal Oak, Michigan, United States, 48073
Troy, Michigan, United States, 48085
United States, Minnesota
Duluth, Minnesota, United States, 55805
United States, Mississippi
Picayune, Mississippi, United States, 39466
United States, Missouri
Kansas, Missouri, United States, 64111
Saint Louis, Missouri, United States, 63110
United States, Montana
Butte, Montana, United States, 59701
United States, Nebraska
Omaha, Nebraska, United States, 68131
United States, Nevada
Las Vegas, Nevada, United States, 89109
Reno, Nevada, United States, 89502
United States, 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
United States, 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
United States, North Carolina
Durham, North Carolina, United States, 27710
United States, Ohio
Cincinnati, Ohio, United States, 45267
Cleveland, Ohio, United States, 44106-5072
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Camp Hill, Pennsylvania, United States, 17011
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Charleston, South Carolina, United States, 29425
Orangeburg, South Carolina, United States, 29118
United States, Texas
Austin, Texas, United States, 78752
Austin, Texas, United States, 78705
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, 77024
Houston, Texas, United States, 77030
McAllen, Texas, United States, 78501
Mission, Texas, United States, 78572
San Antonio, Texas, United States, 78205
San Antonio, Texas, United States, 78258
Victoria, Texas, United States, 77901
United States, Vermont
Colchester, Vermont, United States, 05401
United States, Virginia
Charlottesville, Virginia, United States, 22908
Richmond, Virginia, United States, 23249
United States, Washington
Everett, Washington, United States, 98201
United States, West Virginia
Huntington, West Virginia, United States, 25701
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, Queensland
Redcliffe, Queensland, Australia, 4020
Australia, South Australia
Bedford Park, South Australia, Australia, 5042
Australia, Western Australia
Nedlands, Western Australia, Australia, 6009
Milton, Australia, Qld 4064
Parkville, Australia, Vic 3050
Randwick, Australia
Richmond, Australia, Vic 3121
Feldkirch, Austria, 6800
Gratwein, Austria, 8112
Graz, Austria, 8036
Hartberg, Austria, 8230
Linz, Austria, 4020
Wien, Austria, 1100
Wien, Austria, 1160
Zams, Austria, 6511
Bruxelles, Belgium, 1070
Huy, Belgium, 4500
Leper, Belgium, 8900
Leuven, Belgium, 3000
Yvoir, Belgium, 5530
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, 41810-011
Salvador/BA, Brazil, 40140-110
Sao Paulo, Brazil, 04012-909
São José do Rio Preto- SP, Brazil, 15090-000
SãO Paulo, Brazil, 01323-903
São Paulo, Brazil, 01308-050
Gabrovo, Bulgaria, 5300
Pleven, Bulgaria, 5800
Plovdiv, Bulgaria, 4002
Sandanski, Bulgaria, 2800
Sliven, Bulgaria, 8800
Sofia, Bulgaria, 1606
Sofia, Bulgaria, 1202
Sofia, Bulgaria, 1233
Sofia, Bulgaria, 1407
Sofia, Bulgaria, 1784
Sofia, Bulgaria
Yambol, Bulgaria, 8600
Canada, Alberta
Edmonton, Alberta, Canada, T6K4B3
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
Hamilton, Ontario, Canada, L8N 4A6
Hamilton, Ontario, Canada, L8L 2X2
Kitchener, Ontario, Canada, N2M1B2
Ottawa, Ontario, Canada, K1H 8L6
Thunder Bay, Ontario, Canada, P7B 6R4
Canada, Quebec
Montreal, Quebec, Canada, H1T2M4
Ontario, Canada, N8X 5A6
Quebec, Canada, G1V 4G5
La Serena, Chile, 170000
Osorno, Chile
Santiago, Chile
Santiago, Chile, 7650568
Temuco, Chile, 4781173
Viña del Mar, Chile, 2570017
Krapinske Toplice, Croatia, 49217
Pula, Croatia, 52100
Rijeka, Croatia, 51000
Varazdin, Croatia, 42000
Zadar, Croatia, 23000
Zagreb, Croatia, 1000
Zagreb, Croatia, 10000
Czech Republic
Caslav, Czech Republic, 286 01
Chrudim, Czech Republic, 537 27
Hradec Kralove, Czech Republic, 500 05
Kladno, Czech Republic, 272 01
Kromeriz, Czech Republic, 76701
Kyjov, Czech Republic, 697 33
Liberec, Czech Republic, 460 63
Litomysl, Czech Republic, 570 14
Olomouc, Czech Republic, 771 11
Ostrava, Czech Republic, 703 84
Plzen - Bory, Czech Republic, 305 99
Praha, Czech Republic, 128 08
Praha 1, Czech Republic, 110 00
Praha 1, Czech Republic, 118 00
Praha 10, Czech Republic, 100 34
Praha 5, Czech Republic, 150 06
Slany, Czech Republic, 274 01
Strakonice, Czech Republic, 386 29
Teplice, Czech Republic, 415 29
Usti nad Labem, Czech Republic, 401 13
Zlin, Czech Republic, 762 75
Znojmo, Czech Republic, 669 02
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
Tallinn, Estonia, EE-10138
Tallinn, Estonia, EE-13419
Tartu, Estonia, EE-51014
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
Angers, France, 49100
Arras, France, 62022
Avignon, France, 84918
Bois-Guillaume, France, 76230
Bordeaux, France, 33075
Brest, France, 29200
Brest, France, 29609
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, 75004
Paris, France, 75010
Paris, France, 75908
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
Tbilisi, Georgia, 0183
Tbilisi, Georgia, 0159
Tbilisi, Georgia, 0144
Altenburg, Germany, 04600
Bad Friedrichshall, Germany, 74173
Berlin, Germany, 10787
Bonn, Germany, 53115
Dresden, Germany, 01067
Dresden, Germany, 01307
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
Baja, Hungary, 6500
Balassagyarmat, Hungary, 2660
Balatonfüred, Hungary, 8231
Berettyóújfalu, Hungary, 4100
Budapest, Hungary, 1145
Budapest, Hungary, 1097
Budapest, Hungary, 1122
Budapest, Hungary, 1125
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
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
Castelfranco Veneto, Treviso, Italy, 31033
Bollate, Italy, 20021
Frenze, Italy, 50134
Genova, Italy, 16128
Milano, Italy, 20085
Milano, Italy, 20132
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
Daugavpils, Latvia, LV-5417
Liepaja, Latvia, LV-3414
Riga, Latvia, LV-1002
Riga, Latvia, LV-1038
Valmiera, Latvia, LV-4201
Alytus, Lithuania, LT-62114
Kaunas, Lithuania, LT-44320
Kaunas, Lithuania, LT-45130
Kaunas, Lithuania, LT-47144
Klaipeda, Lithuania, LT-92288
Klaipeda, Lithuania, LT-92231
Siauliai, Lithuania, LT-76231
Utena, Lithuania, 28151
Vilnius, Lithuania, LT-04130
Vilnius, Lithuania, LT-08411
Vilnius, Lithuania, LT-10207
Picayune, MS, Montserrat, 39466
Arequipa, Peru, 05154
Callao, Peru, CALLAO 2
Lima, Peru, 01
Lima, Peru, 18
Lima, Peru, Lima 11
Lima, Peru, LIMA 13
Bialystok, Poland, 15-276
Bydgoszcz, Poland, 85-168
Bydgoszcz, Poland, 85-681
Czeladz, Poland, 41-250
Gdansk, Poland, 80-803
Krakow, Poland, 31-913
Krakow, Poland, 31-121
Skierniewice, Poland, 96-100
Tarnobrzeg, Poland, 39-400
Warszawa, Poland, 01-138
Warszawa, Poland, 02-097
Wloclawek, Poland, 87-800
Baia, Romania, 430031
Bucharest, Romania, 020475
Bucharest, Romania, 021659
Bucharest, Romania, 041915
Bucharest, Romania, 022328
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, 656024
Barnaul, Russian Federation, 656045
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, 117292
Moscow, Russian Federation, 119881
Moscow, Russian Federation, 111539
Moscow, Russian Federation, 121552
Moscow, Russian Federation, 127473
Murmansk, Russian Federation, 183047
Novosibirsk, Russian Federation, 630007
Novosibirsk, Russian Federation, 630051
Novosibirsk, Russian Federation, 630054
Rostov-on-Don, Russian Federation, 344022
Samara, Russian Federation, 443070
Saratov, Russian Federation, 410028
Saratov, Russian Federation, 410053
Saratov, Russian Federation, 410054
Smolensk, Russian Federation, 214018
St. Petersburg, Russian Federation, 192242
St. Petersburg, Russian Federation, 195067
St. Petersburg, Russian Federation, 196247
St. Petersburg, Russian Federation, 197022
St. Petersburg, Russian Federation, 198205
St. Petersburg, Russian Federation, 199106
St.Petersburg, Russian Federation, 191025
Tomsk, Russian Federation, 643012
Yaroslavl, Russian Federation, 150003
Yaroslavl, Russian Federation, 150030
Belgrade, Serbia, 11000
Kragujevac, Serbia, 34000
Nis, Serbia, 18000
Niska Banja, Serbia, 18205
Pancevo, Serbia, 26000
Sremska Kamenica, Serbia, 21204
Singapore, Singapore, 169609
Singapore, Singapore, 169608
Singapore, Singapore, 119074
Bratislava, Slovakia, 83305
Nitra, Slovakia, 949 01
Nitra, Slovakia, 94901
South Africa
Johannesburg, Gauteng, South Africa, 2021
Johannesburg, Gauteng, South Africa, 2193
Cape Town, Western Cape, South Africa, 7530
Pretoria, South Africa, Gauteng 0084
Worcester, South Africa, 6850
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
Madrid, Communidad de, Spain, 28007
Orihuela, Comunidad Valenciana, Spain, 03314
Vigo, Galicia, Spain, 36204
Madrid, Madrid, Communidad de, Spain, 28034
Majadahonda, Madrid, Communidad de, Spain, 28222
San Sebastián de los Reyes, Madrid, Communidad de, Spain, 28702
Barcelona, Spain, 08023
Barcelona, Spain, 08041
Cartagena, Spain, 30202
Girona, Spain, 17007
Olot, Spain, 17800
Pontevedra, Spain, 36001
Salamanca, Spain, 37007
Terrassa, Spain, 08221
Donetsk, Ukraine, 83045
Donetsk, Ukraine, 83114
Ivano-Frankivsk, Ukraine
Ivano-Frankivsk, Ukraine, 76008
Kharkiv, Ukraine, 61018
Kharkiv, Ukraine, 61039
Kharkiv, Ukraine, 61176
Kharkiv,, Ukraine, 61058
Kherson, Ukraine, 73039
Kirovograd, Ukraine, 25006
Kyiv, Ukraine, 03680
Kyiv, Ukraine, 02091
Kyiv, Ukraine, 02660
Kyiv, Ukraine, 04060
Kyiv, Ukraine, 01023
Lugansk, Ukraine, 91011
Lutsk, Ukraine, 43024
Lviv, Ukraine, 79010
Odesa, Ukraine, 65025
Odesa, Ukraine, 65009
Odesa, Ukraine, 65014
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, WC1E 6HX
London, United Kingdom, SE5 9RS
London, United Kingdom, EC1M 6BQ
Manchester, United Kingdom, M23 9LT
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Romford, United Kingdom, RM7 0AG
Southall, United Kingdom, UB1 3HW
Sponsors and Collaborators
Portola Pharmaceuticals
  More Information

No publications provided by Portola Pharmaceuticals

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Portola Pharmaceuticals Identifier: NCT01583218     History of Changes
Other Study ID Numbers: 11-019
Study First Received: April 16, 2012
Last Updated: November 3, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Portola Pharmaceuticals:
Phase III

Additional relevant MeSH terms:
Venous Thromboembolism
Venous Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Vascular Diseases processed this record on November 30, 2015