AzTrials
AzTrials

Venous Thromboembolism (VTE)Phase 3APEXNCT01583218

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

A Phase 3 study testing Betrixaban and Enoxaparin in people with Venous Thromboembolism (VTE), run by Portola Pharmaceuticals at 462 sites in 34 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Venous Thromboembolism (VTE)
What is being tested?
Betrixaban and Enoxaparin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7,513 participants
Where
462 sitesin 34 countries
Study dates
Mar 2012to Jan 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

462 sites in 34 countries.

462 sites in 34 countries

United States75 sites

  • Study site

    Annapolis, Maryland, 21401

  • Study site

    Atlantic City, New Jersey, 08401

  • Study site

    Austin, Texas, 78705

  • Study site

    Austin, Texas, 78752

  • Study site

    Bakersfield, California, 93308

  • Study site

    Baltimore, Maryland, 21287

  • Study site

    Bay Pines, Florida, 33744

  • Study site

    Bellaire, Texas, 77401

  • Study site

    Birmingham, Alabama, 35294

  • Study site

    Buffalo, New York, 14209

  • Study site

    Butte, Montana, 59701

  • Study site

    Camp Hill, Pennsylvania, 17011

  • Study site

    Carmel, Indiana, 46032

  • Study site

    Charleston, South Carolina, 29425

  • Study site

    Charlottesville, Virginia, 22908

  • Study site

    Chicago, Illinois, 60611

  • Study site

    Cincinnati, Ohio, 45267

  • Study site

    Clearwater, Florida, 33756

  • Study site

    Cleveland, Ohio, 44106-5072

  • Study site

    Colchester, Vermont, 05401

  • Study site

    Columbus, Georgia, 31904

  • Study site

    Columbus, Ohio, 43210

  • Study site

    Corsicana, Texas, 75110

  • Study site

    Dallas, Texas, 75216

  • Study site

    Davenport, Iowa, 52803

  • Study site

    Decatur, Georgia, 30030

  • Study site

    Detroit, Michigan, 48202

  • Study site

    Duluth, Minnesota, 55805

  • Study site

    Durham, North Carolina, 27710

  • Study site

    Englewood, Colorado, 80113

  • Study site

    Everett, Washington, 98201

  • Study site

    Fort Worth, Texas, 76104

  • Study site

    Fresno, California, 93701

  • Study site

    Grand Blanc, Michigan, 48439

  • Study site

    Hazard, Kentucky, 41701

  • Study site

    Houston, Texas, 77024

  • Study site

    Houston, Texas, 77030

  • Study site

    Huntington, West Virginia, 25701

  • Study site

    Jacksonville, Florida, 32216

  • Study site

    Kansas City, Missouri, 64111

  • Study site

    La Mesa, California, 91942

  • Study site

    Las Vegas, Nevada, 89109

  • Study site

    Long Beach, California, 90822

  • Study site

    Los Angeles, California, 90073

  • Study site

    Manhasset, New York, 11030

  • Study site

    McAllen, Texas, 78501

  • Study site

    Miami, Florida, 33143

  • Study site

    Mission, Texas, 78572

  • Study site

    Modesto, California, 95350

  • Study site

    Oak Park, Illinois, 60302

  • Study site

    Omaha, Nebraska, 68131

  • Study site

    Orangeburg, South Carolina, 29118

  • Study site

    Pensacola, Florida, 32504

  • Study site

    Philadelphia, Pennsylvania, 19107

  • Study site

    Picayune, Mississippi, 39466

  • Study site

    Pomona, New Jersey, 08240

  • Study site

    Reno, Nevada, 89502

  • Study site

    Richmond, Virginia, 23249

  • Study site

    Royal Oak, Michigan, 48073

  • Study site

    San Antonio, Texas, 78205

  • Study site

    San Antonio, Texas, 78258

  • Study site

    San Diego, California, 92120

  • Study site

    Sarasota, Florida, 34232

  • Study site

    Somerville, New Jersey, 08876

  • Study site

    St Louis, Missouri, 63110

  • Study site

    Stanford, California, 94305

  • Study site

    Staten Island, New York, 10305

  • Study site

    Summit, New Jersey, 07901

  • Study site

    Topeka, Kansas, 66604

  • Study site

    Torrance, California, 90509

  • Study site

    Troy, Michigan, 48085

  • Study site

    Valhalla, New York, 10595

  • Study site

    Vero Beach, Florida, 32960

  • Study site

    Victoria, Texas, 77901

  • Study site

    Windsor Heights, Iowa, 50324

Other trials in United States

Russia42 sites

  • Study site

    Arkhangelsk, 163045

  • Study site

    Barnaul, 656024

  • Study site

    Barnaul, 656045

  • Study site

    Belgorod, 308007

  • Study site

    Chelyabinsk, 454048

  • Study site

    Chelyabinsk, 454091

  • Study site

    Irkutsk, 664049

  • Study site

    Kaluga, 428007

  • Study site

    Kazan', 420012

  • Study site

    Kazan', 420043

  • Study site

    Kemerovo, 650002

  • Study site

    Kirov, 610014

  • Study site

    Krasnodar, 350086

  • Study site

    Lubertsy, 140006

  • Study site

    Moscow, 111539

  • Study site

    Moscow, 117292

  • Study site

    Moscow, 119881

  • Study site

    Moscow, 119992

  • Study site

    Moscow, 121552

  • Study site

    Moscow, 127473

  • Study site

    Murmansk, 183047

  • Study site

    Novosibirsk, 630007

  • Study site

    Novosibirsk, 630051

  • Study site

    Novosibirsk, 630054

  • Study site

    Rostov-on-Don, 344022

  • Study site

    Saint Petersburg, 191025

  • Study site

    Saint Petersburg, 192242

  • Study site

    Saint Petersburg, 195067

  • Study site

    Saint Petersburg, 196247

  • Study site

    Saint Petersburg, 197022

  • Study site

    Saint Petersburg, 198205

  • Study site

    Saint Petersburg, 199106

  • Study site

    Samara, 443070

  • Study site

    Saratov, 410028

  • Study site

    Saratov, 410053

  • Study site

    Saratov, 410054

  • Study site

    Smolensk, 214018

  • Study site

    Tomsk, 643012

  • Study site

    Yaroslavl, 150003

  • Study site

    Yaroslavl, 150030

  • Study site

    Yekaterinburg, 620039

  • Study site

    Yekaterinburg, 620219

Other trials in Russia

France29 sites

  • Study site

    Angers, 49100

  • Study site

    Arras, 62022

  • Study site

    Avignon, 84918

  • Study site

    Bois-Guillaume, 76230

  • Study site

    Bordeaux, 33075

  • Study site

    Brest, 29200

  • Study site

    Brest, 29609

  • Study site

    Cambrai, 59400

  • Study site

    Castelnau-le-Lez, 34170

  • Study site

    Clermont-Ferrand, 63003

  • Study site

    Colombes, 92700

  • Study site

    Dijon, 21079

  • Study site

    La Tronche, 38043

  • Study site

    Le Mans, 72037

  • Study site

    Lille, 59020

  • Study site

    Limoges, 87 042

  • Study site

    Montpellier, 34295

  • Study site

    Nantes, 44093

  • Study site

    Nîmes, 30029 cedex 9

  • Study site

    Paris, 75004

  • Study site

    Paris, 75010

  • Study site

    Paris, 75908

  • Study site

    Pierre-Bénite, 69495

  • Study site

    Quimper, 29107

  • Study site

    Rennes, 35203

  • Study site

    Saint-Priest En Jarrez, 42055

  • Study site

    Tourcoing, 59200

  • Study site

    Valenciennes, 59300

  • Study site

    Vernon, 27207

Other trials in France

Ukraine28 sites

  • Study site

    Donetsk, 83045

  • Study site

    Donetsk, 83114

  • Study site

    Ivano-Frankivsk, 76008

  • Study site

    Ivano-Frankivsk

  • Study site

    Kharkiv, 61018

  • Study site

    Kharkiv, 61039

  • Study site

    Kharkiv, 61058

  • Study site

    Kharkiv, 61176

  • Study site

    Kherson, 73039

  • Study site

    Kirovograd, 25006

  • Study site

    Kyiv, 01023

  • Study site

    Kyiv, 02091

  • Study site

    Kyiv, 02660

  • Study site

    Kyiv, 03680

  • Study site

    Kyiv, 04060

  • Study site

    Luhansk, 91011

  • Study site

    Lutsk, 43024

  • Study site

    Lviv, 79010

  • Study site

    Odesa, 65009

  • Study site

    Odesa, 65014

  • Study site

    Odesa, 65025

  • Study site

    Rivne, 33001

  • Study site

    Simferopol, 95026

  • Study site

    Uzhhorod, 88000

  • Study site

    Vinnytsia, 21005

  • Study site

    Yevpatoriya, 97400

  • Study site

    Zaporizhzhya, 69000

  • Study site

    Zaporizhzhya, 69065

Other trials in Ukraine

Germany24 sites

  • Study site

    Altenburg, 04600

  • Study site

    Bad Friedrichshall, 74173

  • Study site

    Berlin, 10787

  • Study site

    Bonn, 53115

  • Study site

    Dresden, 01067

  • Study site

    Dresden, 01307

  • Study site

    Essen, 45147

  • Study site

    Hamburg, 22559

  • Study site

    Heidelberg, 69120

  • Study site

    Karlbad, 76307

  • Study site

    Ludwigshafen, 67063

  • Study site

    Magdeburg, 39120

  • Study site

    Mainz, 55131

  • Study site

    Minden, 32429

  • Study site

    Möchengladbach, 41063

  • Study site

    Neuss, 41464

  • Study site

    Oberhausen, 46045

  • Study site

    Paderborn, 33098

  • Study site

    Rüsselsheim am Main, 65428

  • Study site

    Troisdorf

  • Study site

    Weiden, 92637

  • Study site

    Wesel, 46483

  • Study site

    Wiesbaden, 65199

  • Study site

    Witten, 58455

Other trials in Germany

Czechia22 sites

  • Study site

    Čáslav, 286 01

  • Study site

    Chrudim, 537 27

  • Study site

    Hradec Králové, 500 05

  • Study site

    Kladno, 272 01

  • Study site

    Kroměříž, 76701

  • Study site

    Kyjov, 697 33

  • Study site

    Liberec, 460 63

  • Study site

    Litomyšl, 570 14

  • Study site

    Olomouc, 771 11

  • Study site

    Ostrava, 703 84

  • Study site

    Plzen - Bory, 305 99

  • Study site

    Prague, 100 34

  • Study site

    Prague, 110 00

  • Study site

    Prague, 118 00

  • Study site

    Prague, 128 08

  • Study site

    Prague, 150 06

  • Study site

    Slaný, 274 01

  • Study site

    Strakonice, 386 29

  • Study site

    Teplice, 415 29

  • Study site

    Ústí nad Labem, 401 13

  • Study site

    Zlín, 762 75

  • Study site

    Znojmo, 669 02

Other trials in Czechia

Hungary22 sites

  • Study site

    Baja, 6500

  • Study site

    Balassagyarmat, 2660

  • Study site

    Balatonfüred, 8231

  • Study site

    Berettyóújfalu, 4100

  • Study site

    Budapest, 1097

  • Study site

    Budapest, 1122

  • Study site

    Budapest, 1125

  • Study site

    Budapest, 1134

  • Study site

    Budapest, 1145

  • Study site

    Cegléd, 2700

  • Study site

    Debrecen, 4032

  • Study site

    Debrecen, H-4012

  • Study site

    Eger, 3300

  • Study site

    Gyula, 5700

  • Study site

    Hódmezövásárhely, 6800

  • Study site

    Kistarcsa, 2143

  • Study site

    Mohács, 7700

  • Study site

    Nagykanizsa, 8800

  • Study site

    Szekszárd, 7100

  • Study site

    Szolnok, 5000

  • Study site

    Veszprém, 8200

  • Study site

    Zalaegerszeg, 8900

Other trials in Hungary

Spain20 sites

  • Study site

    Barcelona, Catalonia, 08003

  • Study site

    Barcelona, Catalonia, 08036

  • Study site

    Barcelona, 08023

  • Study site

    Barcelona, 08041

  • Study site

    Cartagena, 30202

  • Study site

    Girona, 17007

  • Study site

    L'Hospitalet de Llobregat, Catalonia, 08907

  • Study site

    Madrid, Communidad de, 28007

  • Study site

    Madrid, Madrid, Communidad de, 28034

  • Study site

    Majadahonda, Madrid, Communidad de, 28222

  • Study site

    Olot, 17800

  • Study site

    Orihuela, Valencia, 03314

  • Study site

    Pontevedra, 36001

  • Study site

    Sabadell, Catalonia, 08208

  • Study site

    Salamanca, 37007

  • Study site

    San Sebastián de los Reyes, Madrid, Communidad de, 28702

  • Study site

    Sant Boi de Llobregat, Catalonia, '08830

  • Study site

    Tarragona, Catalonia, 43007

  • Study site

    Terrassa, 08221

  • Study site

    Vigo, Galicia, 36204

Other trials in Spain

Brazil17 sites

  • Study site

    Belo Horizonte - MG, 30150-221

  • Study site

    Botucatu, 18618-970

  • Study site

    Brasília, 70710

  • Study site

    Brasilia/DF, 70710-905

  • Study site

    Campinas, 13083-970

  • Study site

    Campinas, Sao Paulo, 13059-740

  • Study site

    Curitiba - PR, 80030-001

  • Study site

    Porto Alegre, 90620-001

  • Study site

    Porto Alegre, 90880-480

  • Study site

    Porto Alegre/RS, 90620-001

  • Study site

    Salvador, 41810-011

  • Study site

    Salvador/BA, 40140-110

  • Study site

    Salvador/BA, 41810-011

  • Study site

    São José Do Rio Preto- SP, 15090-000

  • Study site

    São Paulo, 01308-050

  • Study site

    São Paulo, 01323-903

  • Study site

    São Paulo, 04012-909

Other trials in Brazil

Italy15 sites

  • Study site

    Bollate, 20021

  • Study site

    Castelfranco Veneto, Treviso, 31033

  • Study site

    Frenze, 50134

  • Study site

    Genova, 16128

  • Study site

    Milan, 20085

  • Study site

    Milan, 20132

  • Study site

    Naples, 80131

  • Study site

    Parma, 43100

  • Study site

    Pavia, 27100

  • Study site

    Piacenza, 29121

  • Study site

    Reggio Emilia, 42100

  • Study site

    Roma, 00168

  • Study site

    Varese, 21100

  • Study site

    Venezia, 30122

  • Study site

    Vittorio Veneto TV, 31029

Other trials in Italy

Romania13 sites

  • Study site

    Baia, 430031

  • Study site

    Bucharest, 020475

  • Study site

    Bucharest, 021659

  • Study site

    Bucharest, 022328

  • Study site

    Bucharest, 041915

  • Study site

    Cluj-Napoca, 400006

  • Study site

    Cluj-Napoca, 40001

  • Study site

    Craiova, 200642

  • Study site

    Iași, 700620

  • Study site

    Oradea, 410169

  • Study site

    Piteşti, 110884

  • Study site

    Târgu Mureş, 540136

  • Study site

    Timișoara, 300736

Other trials in Romania

Bulgaria12 sites

  • Study site

    Gabrovo, 5300

  • Study site

    Pleven, 5800

  • Study site

    Plovdiv, 4002

  • Study site

    Sandanski, 2800

  • Study site

    Sliven, 8800

  • Study site

    Sofia, 1202

  • Study site

    Sofia, 1233

  • Study site

    Sofia, 1407

  • Study site

    Sofia, 1606

  • Study site

    Sofia, 1784

  • Study site

    Sofia

  • Study site

    Yambol, 8600

Other trials in Bulgaria

Poland12 sites

  • Study site

    Bialystok, 15-276

  • Study site

    Bydgoszcz, 85-168

  • Study site

    Bydgoszcz, 85-681

  • Study site

    Czeladź, 41-250

  • Study site

    Gdansk, 80-803

  • Study site

    Krakow, 31-121

  • Study site

    Krakow, 31-913

  • Study site

    Skierniewice, 96-100

  • Study site

    Tarnobrzeg, 39-400

  • Study site

    Warsaw, 01-138

  • Study site

    Warsaw, 02-097

  • Study site

    Włocławek, 87-800

Other trials in Poland

Lithuania11 sites

  • Study site

    Alytus, LT-62114

  • Study site

    Kaunas, LT-44320

  • Study site

    Kaunas, LT-45130

  • Study site

    Kaunas, LT-47144

  • Study site

    Klaipėda, LT-92231

  • Study site

    Klaipėda, LT-92288

  • Study site

    Šiauliai, LT-76231

  • Study site

    Utena, 28151

  • Study site

    Vilnius, LT-04130

  • Study site

    Vilnius, LT-08411

  • Study site

    Vilnius, LT-10207

Other trials in Lithuania

Canada10 sites

  • Study site

    Edmonton, Alberta, T6K4B3

  • Study site

    Halifax, Nova Scotia, B3H 3A7

  • Study site

    Hamilton, Ontario, L8L 2X2

  • Study site

    Hamilton, Ontario, L8N 4A6

  • Study site

    Kitchener, Ontario, N2M1B2

  • Study site

    Montreal, Quebec, H1T2M4

  • Study site

    Ontario, N8X 5A6

  • Study site

    Ottawa, Ontario, K1H 8L6

  • Study site

    Québec, G1V 4G5

  • Study site

    Thunder Bay, Ontario, P7B 6R4

Other trials in Canada

Denmark10 sites

  • Study site

    Aarhus N, DK-8200

  • Study site

    Frederiksberg, DK-2000

  • Study site

    Glostrup Municipality, DK-2600

  • Study site

    Haderslev, DK-6100

  • Study site

    Hellerup, DK-2900

  • Study site

    Hillerød, DK-3400

  • Study site

    Hvidovre, DK-2650

  • Study site

    København NV, DK-2400

  • Study site

    Silkeborg, DK-8600

  • Study site

    Slagelse, DK-4200

Other trials in Denmark

Israel10 sites

  • Study site

    Afula, 18101

  • Study site

    Ashkelon, 78278

  • Study site

    Haifa, 31048

  • Study site

    Haifa, 31096

  • Study site

    Jerusalem, 91120

  • Study site

    Kfar Saba, 44281

  • Study site

    Petah Tikva, 49100

  • Study site

    Safed, 13100

  • Study site

    Tel Aviv, 64239

  • Study site

    Tsrifin, 70300

Other trials in Israel

Argentina8 sites

  • Study site

    Buenos Aires, 1280

  • Study site

    Buenos Aires, C1181ACH

  • Study site

    Córdoba, 5000

  • Study site

    Coronel Suarez, Buenos Aires, B7540DOL

  • Study site

    Corrientes, W3400AMZ

  • Study site

    El Talar, 1618

  • Study site

    Rosario, Santa Fe, S2000DSV

  • Study site

    San Miguel de Tucumán, T4000JCU

Other trials in Argentina

Austria8 sites

  • Study site

    Feldkirch, 6800

  • Study site

    Gratwein, 8112

  • Study site

    Graz, 8036

  • Study site

    Hartberg, 8230

  • Study site

    Linz, 4020

  • Study site

    Vienna, 1100

  • Study site

    Vienna, 1160

  • Study site

    Zams, 6511

Other trials in Austria

Australia7 sites

  • Study site

    Bedford Park, South Australia, 5042

  • Study site

    Milton, Qld 4064

  • Study site

    Nedlands, Western Australia, 6009

  • Study site

    Parkville, Vic 3050

  • Study site

    Randwick

  • Study site

    Redcliffe, Queensland, 4020

  • Study site

    Richmond, Vic 3121

Other trials in Australia

Croatia7 sites

  • Study site

    Krapinske Toplice, 49217

  • Study site

    Pula, 52100

  • Study site

    Rijeka, 51000

  • Study site

    Varaždin, 42000

  • Study site

    Zadar, 23000

  • Study site

    Zagreb, 10000

  • Study site

    Zagreb, 1000

Other trials in Croatia

Finland7 sites

  • Study site

    Helsinki, FI-00290

  • Study site

    Jyväskylä, FI-40620

  • Study site

    Kouvola, FI-45750

  • Study site

    Mikkeli, FI-50100

  • Study site

    Pori, FI-28500

  • Study site

    Tampere

  • Study site

    Turku, FI-20520

Other trials in Finland

United Kingdom7 sites

  • Study site

    London, EC1M 6BQ

  • Study site

    London, SE5 9RS

  • Study site

    London, WC1E 6HX

  • Study site

    Manchester, M23 9LT

  • Study site

    Newcastle upon Tyne, NE7 7DN

  • Study site

    Romford, RM7 0AG

  • Study site

    Southall, UB1 3HW

Other trials in United Kingdom

Chile6 sites

  • Study site

    La Serena, 170000

  • Study site

    Osorno

  • Study site

    Santiago, 7650568

  • Study site

    Santiago

  • Study site

    Temuco, 4781173

  • Study site

    Viña del Mar, 2570017

Other trials in Chile

Peru6 sites

  • Study site

    Arequipa, 05154

  • Study site

    Callao, CALLAO 2

  • Study site

    Lima, 01

  • Study site

    Lima, 18

  • Study site

    Lima, Lima 11

  • Study site

    Lima, LIMA 13

Other trials in Peru

Serbia6 sites

  • Study site

    Belgrade, 11000

  • Study site

    Kamenitz, 21204

  • Study site

    Kragujevac, 34000

  • Study site

    Niš, 18000

  • Study site

    Niška Banja, 18205

  • Study site

    Pančevo, 26000

Other trials in Serbia

Belgium5 sites

  • Study site

    Brussels, 1070

  • Study site

    Huy, 4500

  • Study site

    Leper, 8900

  • Study site

    Leuven, 3000

  • Study site

    Yvoir, 5530

Other trials in Belgium

Latvia5 sites

  • Study site

    Daugavpils, LV-5417

  • Study site

    Liepāja, LV-3414

  • Study site

    Riga, LV-1002

  • Study site

    Riga, LV-1038

  • Study site

    Valmiera, LV-4201

Other trials in Latvia

South Africa5 sites

  • Study site

    Cape Town, Western Cape, 7530

  • Study site

    Johannesburg, Gauteng, 2021

  • Study site

    Johannesburg, Gauteng, 2193

  • Study site

    Pretoria, Gauteng 0084

  • Study site

    Worcester, 6850

Other trials in South Africa

Estonia3 sites

  • Study site

    Tallinn, EE-10138

  • Study site

    Tallinn, EE-13419

  • Study site

    Tartu, EE-51014

Other trials in Estonia

Georgia3 sites

  • Study site

    Tbilisi, 0144

  • Study site

    Tbilisi, 0159

  • Study site

    Tbilisi, 0183

Other trials in Georgia

Singapore3 sites

  • Study site

    Singapore, 119074

  • Study site

    Singapore, 169608

  • Study site

    Singapore, 169609

Other trials in Singapore

Slovakia3 sites

  • Study site

    Bratislava, 83305

  • Study site

    Nitra, 949 01

  • Study site

    Nitra, 94901

Other trials in Slovakia

Montserrat1 site

  • Study site

    Picayune, MS, 39466

About this study

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

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.

Being tested
Betrixaban, Enoxaparin
Keywords
Phase III
Medical subject headings
Venous Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BetrixabanDrug

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

    Enoxaparin Placebo: Once daily, 6-14 days

  • EnoxaparinDrug

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

    Betrixaban Placebo: once daily, 35 days

Study groups in NCT01583218
Study groupRoleWhat they receive
BetrixabanExperimentalDaily oral (PO) betrixaban capsules for 35 to 42 days and subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days
Receives: Drug: Betrixaban
EnoxaparinActive comparatorDaily subcutaneous (SQ) injections of enoxaparin for 10 ± 4 days and oral (PO) betrixaban placebo capsules for 35 to 42 days
Receives: Drug: Enoxaparin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    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).

    Measured: mITT Cohort 1: Between randomization and Day 47 (max)

  2. 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

    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).

    Measured: mITT Cohort 2: Between randomization and Day 47 (max)

  3. mITT: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, VTE-related Death, or Asymptomatic Proximal DVT, Through Visit 3

    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).

    Measured: mITT: Between randomization and Day 47 (max)

  4. Percentage of Participants Experiencing Major Bleeding Through Seven Days After Discontinuation of All Study Medication

    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.

    Measured: Between randomization and Day 49 (max)

Secondary outcomes (3)

  1. mITT Cohort 1: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, or VTE-related Death, Through Visit 3

    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).

    Measured: mITT Cohort 1: Between randomization and Day 42 (max)

  2. mITT Cohort 2: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, or VTE-related Death, Through Visit 3

    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).

    Measured: mITT Cohort 2: Between randomization and Day 42 (max)

  3. mITT: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, or VTE-related Death, Through Visit 3

    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).

    Measured: mITT: Between randomization and Day 42 (max)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionDec 2015
  4. Study completionJan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
7,513 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01583218
Sponsor's protocol ID
11-019
Acronym
APEX
Status last verified
Aug 2023
First submitted
16 Apr 2012
Last updated
7 Aug 2023
Data monitoring committee
Yes

Publications

  • Chi G, Violi F, Pignatelli P, Vestri A, Spagnoli A, Loffredo L, Hernandez AF, Hull RD, Cohen AT, Harrington RA, Goldhaber SZ, Gibson CM. External validation of the ADA score for predicting thrombosis among acutely ill hospitalized medical patients from the APEX Trial. J Thromb Thrombolysis. 2023 Feb;55(2):211-221. doi: 10.1007/s11239-022-02757-8. Epub 2022 Dec 24.

    PubMed 36566304

  • Jamil A, Jamil U, Singh K, Khan F, Chi G. Extended Thromboprophylaxis With Betrixaban or Rivaroxaban for Acutely Ill Hospitalized Medical Patients: Meta-Analysis of Prespecified Subgroups. Crit Pathw Cardiol. 2021 Mar 1;20(1):16-24. doi: 10.1097/HPC.0000000000000232.

    PubMed 32657973

  • Yee MK, Gibson CM, Nafee T, Kerneis M, Daaboul Y, Korjian S, Chi G, AlKhalfan F, Hernandez AF, Hull RD, Cohen AT, Goldhaber SZ. Characterization of Major and Clinically Relevant Non-Major Bleeds in the APEX Trial. TH Open. 2019 Apr 17;3(2):e103-e108. doi: 10.1055/s-0039-1685496. eCollection 2019 Apr.

    PubMed 31249989

  • Guy H, Laskier V, Fisher M, Bucior I, Deitelzweig S, Cohen AT. Budget impact analysis of betrixaban for venous thromboembolism prophylaxis in nonsurgical patients with acute medical illness in the United Kingdom. Expert Rev Pharmacoecon Outcomes Res. 2020 Jun;20(3):259-267. doi: 10.1080/14737167.2019.1629905. Epub 2019 Jun 19.

    PubMed 31215264

  • Chi G, Gibson CM, Kalayci A, Cohen AT, Hernandez AF, Hull RD, Kahe F, Jafarizade M, Sharfaei S, Liu Y, Harrington RA, Goldhaber SZ. Extended-duration betrixaban versus shorter-duration enoxaparin for venous thromboembolism prophylaxis in critically ill medical patients: an APEX trial substudy. Intensive Care Med. 2019 Apr;45(4):477-487. doi: 10.1007/s00134-019-05565-6. Epub 2019 Feb 18.

    PubMed 30778649

  • Kalayci A, Gibson CM, Chi G, Yee MK, Korjian S, Datta S, Nafee T, Gurin M, Haroian N, Qamar I, Hull RD, Hernandez AF, Cohen AT, Harrington RA, Goldhaber SZ. Asymptomatic Deep Vein Thrombosis is Associated with an Increased Risk of Death: Insights from the APEX Trial. Thromb Haemost. 2018 Dec;118(12):2046-2052. doi: 10.1055/s-0038-1675606. Epub 2018 Nov 12.

    PubMed 30419597

  • Chi G, Gibson CM, Liu Y, Hernandez AF, Hull RD, Cohen AT, Harrington RA, Goldhaber SZ. Inverse relationship of serum albumin to the risk of venous thromboembolism among acutely ill hospitalized patients: Analysis from the APEX trial. Am J Hematol. 2019 Jan;94(1):21-28. doi: 10.1002/ajh.25296. Epub 2018 Oct 17.

    PubMed 30252149

  • Chi G, Goldhaber SZ, Hull RD, Hernandez AF, Kerneis M, Al Khalfan F, Cohen AT, Harrington RA, Gibson CM. Thrombus Burden of Deep Vein Thrombosis and Its Association with Thromboprophylaxis and D-Dimer Measurement: Insights from the APEX Trial. Thromb Haemost. 2017 Dec;117(12):2389-2395. doi: 10.1160/TH17-08-0538. Epub 2017 Dec 6.

    PubMed 29212126

  • Yee MK, Nafee T, Daaboul Y, Korjian S, AlKhalfan F, Kerneis M, Wiest C, Goldhaber SZ, Hernandez AF, Hull RD, Cohen AT, Harrington RA, Gibson CM. Increased benefit of betrixaban among patients with a history of venous thromboembolism: a post-hoc analysis of the APEX trial. J Thromb Thrombolysis. 2018 Jan;45(1):1-8. doi: 10.1007/s11239-017-1583-0.

    PubMed 29188425

  • Chi G, Januzzi JL, Korjian S, Daaboul Y, Goldhaber SZ, Hernandez AF, Hull RD, Gold A, Cohen AT, Harrington RA, Gibson CM. N-terminal pro-B-type natriuretic peptide and the risk of stroke among patients hospitalized with acute heart failure: an APEX trial substudy. J Thromb Thrombolysis. 2017 Nov;44(4):457-465. doi: 10.1007/s11239-017-1552-7.

    PubMed 28905172

  • Arbetter DF, Jain P, Yee MK, Michalak N, Hernandez AF, Hull RD, Goldhaber SZ, Harrington RA, Gold A, Cohen AT, Gibson CM. Competing risk analysis in a large cardiovascular clinical trial: An APEX substudy. Pharm Stat. 2017 Nov;16(6):445-450. doi: 10.1002/pst.1823. Epub 2017 Aug 24.

    PubMed 28840662

  • Chi G, Goldhaber SZ, Kittelson JM, Turpie AGG, Hernandez AF, Hull RD, Gold A, Curnutte JT, Cohen AT, Harrington RA, Gibson CM. Effect of extended-duration thromboprophylaxis on venous thromboembolism and major bleeding among acutely ill hospitalized medical patients: a bivariate analysis. J Thromb Haemost. 2017 Oct;15(10):1913-1922. doi: 10.1111/jth.13783. Epub 2017 Sep 4.

    PubMed 28762617

  • Gibson CM, Korjian S, Chi G, Daaboul Y, Jain P, Arbetter D, Goldhaber SZ, Hull R, Hernandez AF, Lopes RD, Gold A, Cohen AT, Harrington RA; APEX Investigators. Comparison of Fatal or Irreversible Events With Extended-Duration Betrixaban Versus Standard Dose Enoxaparin in Acutely Ill Medical Patients: An APEX Trial Substudy. J Am Heart Assoc. 2017 Jul 11;6(7):e006015. doi: 10.1161/JAHA.117.006015.

    PubMed 28698258

  • Gibson CM, Goldhaber SZ, Cohen AT, Nafee T, Hernandez AF, Hull R, Korjian S, Daaboul Y, Chi G, Yee M, Harrington RA. When academic research organizations and clinical research organizations disagree: Processes to minimize discrepancies prior to unblinding of randomized trials. Am Heart J. 2017 Jul;189:1-8. doi: 10.1016/j.ahj.2017.03.018. Epub 2017 Mar 31. No abstract available.

    PubMed 28625365

  • Marszalek J, Mehrsefat S, Chi G. The risk of stroke among acutely ill hospitalized medical patients: lessons from recent trials on extended-duration thromboprophylaxis. Expert Rev Hematol. 2017 Aug;10(8):679-684. doi: 10.1080/17474086.2017.1343662. Epub 2017 Jun 21.

    PubMed 28617144

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Betrixaban and Enoxaparin in people with Venous Thromboembolism (VTE), run by Portola Pharmaceuticals at 462 sites in 34 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 462 sites in United States, Russia, France, Ukraine, Germany and 29 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01583218, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2023.

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