Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study (The APEX Study)
NCT ID: NCT01583218
Last Updated: 2023-08-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
7513 participants
INTERVENTIONAL
2012-03-31
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Betrixaban
Daily oral (PO) betrixaban capsules for 35 to 42 days and subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days
Betrixaban
Betrixaban 80 mg PO once daily (QD) for 35 day + 7 days.
Enoxaparin Placebo: Once daily, 6-14 days
Enoxaparin
Daily subcutaneous (SQ) injections of enoxaparin for 10 ± 4 days and oral (PO) betrixaban placebo capsules for 35 to 42 days
Enoxaparin
Enoxaparin 40 mg subcutaneous (SC) QD for 10 ± 4 days.
Betrixaban Placebo: once daily, 35 days
Interventions
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Betrixaban
Betrixaban 80 mg PO once daily (QD) for 35 day + 7 days.
Enoxaparin Placebo: Once daily, 6-14 days
Enoxaparin
Enoxaparin 40 mg subcutaneous (SC) QD for 10 ± 4 days.
Betrixaban Placebo: once daily, 35 days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
ALL
No
Sponsors
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Portola Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Birmingham, Alabama, United States
Bakersfield, California, United States
Fresno, California, United States
La Mesa, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Modesto, California, United States
San Diego, California, United States
Stanford, California, United States
Torrance, California, United States
Englewood, Colorado, United States
Bay Pines, Florida, United States
Clearwater, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Pensacola, Florida, United States
Sarasota, Florida, United States
Vero Beach, Florida, United States
Columbus, Georgia, United States
Decatur, Georgia, United States
Chicago, Illinois, United States
Oak Park, Illinois, United States
Carmel, Indiana, United States
Davenport, Iowa, United States
Windsor Heights, Iowa, United States
Topeka, Kansas, United States
Hazard, Kentucky, United States
Annapolis, Maryland, United States
Baltimore, Maryland, United States
Detroit, Michigan, United States
Grand Blanc, Michigan, United States
Royal Oak, Michigan, United States
Troy, Michigan, United States
Duluth, Minnesota, United States
Picayune, Mississippi, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Butte, Montana, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Reno, Nevada, United States
Atlantic City, New Jersey, United States
Pomona, New Jersey, United States
Somerville, New Jersey, United States
Summit, New Jersey, United States
Buffalo, New York, United States
Manhasset, New York, United States
Staten Island, New York, United States
Valhalla, New York, United States
Durham, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Camp Hill, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Orangeburg, South Carolina, United States
Austin, Texas, United States
Austin, Texas, United States
Bellaire, Texas, United States
Corsicana, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
McAllen, Texas, United States
Mission, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Victoria, Texas, United States
Colchester, Vermont, United States
Charlottesville, Virginia, United States
Richmond, Virginia, United States
Everett, Washington, United States
Huntington, West Virginia, United States
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Coronel Suarez, Buenos Aires, , Argentina
Corrientes, , Argentina
Córdoba, , Argentina
El Talar, , Argentina
Rosario, Santa Fe, , Argentina
San Miguel de Tucumán, , Argentina
Redcliffe, Queensland, Australia
Bedford Park, South Australia, Australia
Nedlands, Western Australia, Australia
Milton, , Australia
Parkville, , Australia
Randwick, , Australia
Richmond, , Australia
Feldkirch, , Austria
Gratwein, , Austria
Graz, , Austria
Hartberg, , Austria
Linz, , Austria
Vienna, , Austria
Vienna, , Austria
Zams, , Austria
Brussels, , Belgium
Huy, , Belgium
Leper, , Belgium
Leuven, , Belgium
Yvoir, , Belgium
Belo Horizonte - MG, , Brazil
Botucatu, , Brazil
Brasilia/DF, , Brazil
Brasília, , Brazil
Campinas, , Brazil
Campinas, Sao Paulo, , Brazil
Curitiba - PR, , Brazil
Porto Alegre, , Brazil
Porto Alegre, , Brazil
Porto Alegre/RS, , Brazil
Salvador, , Brazil
Salvador/BA, , Brazil
Salvador/BA, , Brazil
São José Do Rio Preto- SP, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
Gabrovo, , Bulgaria
Pleven, , Bulgaria
Plovdiv, , Bulgaria
Sandanski, , Bulgaria
Sliven, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Yambol, , Bulgaria
Edmonton, Alberta, Canada
Halifax, Nova Scotia, Canada
Hamilton, Ontario, Canada
Hamilton, Ontario, Canada
Kitchener, Ontario, Canada
Ottawa, Ontario, Canada
Thunder Bay, Ontario, Canada
Montreal, Quebec, Canada
Ontario, , Canada
Québec, , Canada
La Serena, , Chile
Osorno, , Chile
Santiago, , Chile
Santiago, , Chile
Temuco, , Chile
Viña del Mar, , Chile
Krapinske Toplice, , Croatia
Pula, , Croatia
Rijeka, , Croatia
Varaždin, , Croatia
Zadar, , Croatia
Zagreb, , Croatia
Zagreb, , Croatia
Chrudim, , Czechia
Čáslav, , Czechia
Hradec Králové, , Czechia
Kladno, , Czechia
Kroměříž, , Czechia
Kyjov, , Czechia
Liberec, , Czechia
Litomyšl, , Czechia
Olomouc, , Czechia
Ostrava, , Czechia
Plzen - Bory, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Slaný, , Czechia
Strakonice, , Czechia
Teplice, , Czechia
Ústí nad Labem, , Czechia
Zlín, , Czechia
Znojmo, , Czechia
Aarhus N, , Denmark
Frederiksberg, , Denmark
Glostrup Municipality, , Denmark
Haderslev, , Denmark
Hellerup, , Denmark
Hillerød, , Denmark
Hvidovre, , Denmark
København NV, , Denmark
Silkeborg, , Denmark
Slagelse, , Denmark
Tallinn, , Estonia
Tallinn, , Estonia
Tartu, , Estonia
Helsinki, , Finland
Jyväskylä, , Finland
Kouvola, , Finland
Mikkeli, , Finland
Pori, , Finland
Tampere, , Finland
Turku, , Finland
Angers, , France
Arras, , France
Avignon, , France
Bois-Guillaume, , France
Bordeaux, , France
Brest, , France
Brest, , France
Cambrai, , France
Castelnau-le-Lez, , France
Clermont-Ferrand, , France
Colombes, , France
Dijon, , France
La Tronche, , France
Le Mans, , France
Lille, , France
Limoges, , France
Montpellier, , France
Nantes, , France
Nîmes, , France
Paris, , France
Paris, , France
Paris, , France
Pierre-Bénite, , France
Quimper, , France
Rennes, , France
Saint-Priest En Jarrez, , France
Tourcoing, , France
Valenciennes, , France
Vernon, , France
Tbilisi, , Georgia
Tbilisi, , Georgia
Tbilisi, , Georgia
Altenburg, , Germany
Bad Friedrichshall, , Germany
Berlin, , Germany
Bonn, , Germany
Dresden, , Germany
Dresden, , Germany
Essen, , Germany
Hamburg, , Germany
Heidelberg, , Germany
Karlbad, , Germany
Ludwigshafen, , Germany
Magdeburg, , Germany
Mainz, , Germany
Minden, , Germany
Möchengladbach, , Germany
Neuss, , Germany
Oberhausen, , Germany
Paderborn, , Germany
Rüsselsheim am Main, , Germany
Troisdorf, , Germany
Weiden, , Germany
Wesel, , Germany
Wiesbaden, , Germany
Witten, , Germany
Baja, , Hungary
Balassagyarmat, , Hungary
Balatonfüred, , Hungary
Berettyóújfalu, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Cegléd, , Hungary
Debrecen, , Hungary
Debrecen, , Hungary
Eger, , Hungary
Gyula, , Hungary
Hódmezövásárhely, , Hungary
Kistarcsa, , Hungary
Mohács, , Hungary
Nagykanizsa, , Hungary
Szekszárd, , Hungary
Szolnok, , Hungary
Veszprém, , Hungary
Zalaegerszeg, , Hungary
Afula, , Israel
Ashkelon, , Israel
Haifa, , Israel
Haifa, , Israel
Jerusalem, , Israel
Kfar Saba, , Israel
Petah Tikva, , Israel
Safed, , Israel
Tel Aviv, , Israel
Ẕerifin, , Israel
Castelfranco Veneto, Treviso, Italy
Bollate, , Italy
Frenze, , Italy
Genova, , Italy
Milan, , Italy
Milan, , Italy
Napoli, , Italy
Parma, , Italy
Pavia, , Italy
Piacenza, , Italy
Reggio Emilia, , Italy
Roma, , Italy
Varese, , Italy
Venezia, , Italy
Vittorio Veneto TV, , Italy
Daugavpils, , Latvia
Liepāja, , Latvia
Riga, , Latvia
Riga, , Latvia
Valmiera, , Latvia
Alytus, , Lithuania
Kaunas, , Lithuania
Kaunas, , Lithuania
Kaunas, , Lithuania
Klaipėda, , Lithuania
Klaipėda, , Lithuania
Šiauliai, , Lithuania
Utena, , Lithuania
Vilnius, , Lithuania
Vilnius, , Lithuania
Vilnius, , Lithuania
Picayune, MS, Montserrat
Arequipa, , Peru
Callao, , Peru
Lima, , Peru
Lima, , Peru
Lima, , Peru
Lima, , Peru
Bialystok, , Poland
Bydgoszcz, , Poland
Bydgoszcz, , Poland
Czeladź, , Poland
Gdansk, , Poland
Krakow, , Poland
Krakow, , Poland
Skierniewice, , Poland
Tarnobrzeg, , Poland
Warsaw, , Poland
Warsaw, , Poland
Włocławek, , Poland
Baia, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Cluj-Napoca, , Romania
Cluj-Napoca, , Romania
Craiova, , Romania
Iași, , Romania
Oradea, , Romania
Piteşti, , Romania
Târgu Mureş, , Romania
Timișoara, , Romania
Arkhangelsk, , Russia
Barnaul, , Russia
Barnaul, , Russia
Belgorod, , Russia
Chelyabinsk, , Russia
Chelyabinsk, , Russia
Irkutsk, , Russia
Kaluga, , Russia
Kazan', , Russia
Kazan', , Russia
Kemerovo, , Russia
Kirov, , Russia
Krasnodar, , Russia
Lubertsy, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Murmansk, , Russia
Novosibirsk, , Russia
Novosibirsk, , Russia
Novosibirsk, , Russia
Rostov-on-Don, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Samara, , Russia
Saratov, , Russia
Saratov, , Russia
Saratov, , Russia
Smolensk, , Russia
Tomsk, , Russia
Yaroslavl, , Russia
Yaroslavl, , Russia
Yekaterinburg, , Russia
Yekaterinburg, , Russia
Belgrade, , Serbia
Kamenitz, , Serbia
Kragujevac, , Serbia
Niš, , Serbia
Niška Banja, , Serbia
Pančevo, , Serbia
Singapore, , Singapore
Singapore, , Singapore
Singapore, , Singapore
Bratislava, , Slovakia
Nitra, , Slovakia
Nitra, , Slovakia
Johannesburg, Gauteng, South Africa
Johannesburg, Gauteng, South Africa
Cape Town, Western Cape, South Africa
Pretoria, , South Africa
Worcester, , South Africa
Barcelona, Catalonia, Spain
Barcelona, Catalonia, Spain
L'Hospitalet de Llobregat, Catalonia, Spain
Sabadell, Catalonia, Spain
Sant Boi de Llobregat, Catalonia, Spain
Tarragona, Catalonia, Spain
Madrid, Communidad de, Spain
Vigo, Galicia, Spain
Madrid, Madrid, Communidad de, Spain
Majadahonda, Madrid, Communidad de, Spain
San Sebastián de los Reyes, Madrid, Communidad de, Spain
Orihuela, Valencia, Spain
Barcelona, , Spain
Barcelona, , Spain
Cartagena, , Spain
Girona, , Spain
Olot, , Spain
Pontevedra, , Spain
Salamanca, , Spain
Terrassa, , Spain
Donetsk, , Ukraine
Donetsk, , Ukraine
Ivano-Frankivsk, , Ukraine
Ivano-Frankivsk, , Ukraine
Kharkiv, , Ukraine
Kharkiv, , Ukraine
Kharkiv, , Ukraine
Kharkiv, , Ukraine
Kherson, , Ukraine
Kirovograd, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Luhansk, , Ukraine
Lutsk, , Ukraine
Lviv, , Ukraine
Odesa, , Ukraine
Odesa, , Ukraine
Odesa, , Ukraine
Rivne, , Ukraine
Simferopol, , Ukraine
Uzhhorod, , Ukraine
Vinnytsia, , Ukraine
Yevpatoria, , Ukraine
Zaporizhzhya, , Ukraine
Zaporizhzhya, , Ukraine
London, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Newcastle upon Tyne, , United Kingdom
Romford, , United Kingdom
Southall, , United Kingdom
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Gibson CM, Chi G, Halaby R, Korjian S, Daaboul Y, Jain P, Arbetter D, Goldhaber SZ, Hull R, Hernandez AF, Gold A, Bandman O, Harrington RA, Cohen AT; APEX Investigators. Extended-Duration Betrixaban Reduces the Risk of Stroke Versus Standard-Dose Enoxaparin Among Hospitalized Medically Ill Patients: An APEX Trial Substudy (Acute Medically Ill Venous Thromboembolism Prevention With Extended Duration Betrixaban). Circulation. 2017 Feb 14;135(7):648-655. doi: 10.1161/CIRCULATIONAHA.116.025427. Epub 2016 Nov 14.
Cohen AT, Harrington RA, Goldhaber SZ, Hull RD, Wiens BL, Gold A, Hernandez AF, Gibson CM; APEX Investigators. Extended Thromboprophylaxis with Betrixaban in Acutely Ill Medical Patients. N Engl J Med. 2016 Aug 11;375(6):534-44. doi: 10.1056/NEJMoa1601747. Epub 2016 May 27.
Cohen AT, Harrington R, Goldhaber SZ, Hull R, Gibson CM, Hernandez AF, Kitt MM, Lorenz TJ. The design and rationale for the Acute Medically Ill Venous Thromboembolism Prevention with Extended Duration Betrixaban (APEX) study. Am Heart J. 2014 Mar;167(3):335-41. doi: 10.1016/j.ahj.2013.11.006. Epub 2013 Dec 10.
Other Identifiers
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11-019
Identifier Type: -
Identifier Source: org_study_id
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