Efficacy of Apixaban in Malignancy With Deep Venous Thrombosis
NCT ID: NCT04462003
Last Updated: 2020-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
100 participants
INTERVENTIONAL
2019-07-03
2020-07-03
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
TREATMENT
SINGLE
Study Groups
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Apixaban
50 patients with DVT with malignancy were randomized to apixaban 10 mg twice daily dose for 7 days followed by apixaban 5 mg twice daily
Apixaban
10 mg/12 h for 1 week followed by 5 mg/12 h
Enoxaparin
50 patients with DVT with malignancy were randomized to enoxaparin (1mg/Kg/SC every 12 h)
Enoxaparin
1mg/Kg/sc/12h
Interventions
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Apixaban
10 mg/12 h for 1 week followed by 5 mg/12 h
Enoxaparin
1mg/Kg/sc/12h
Eligibility Criteria
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Exclusion Criteria
* Previous DVT or venous thromboembolism
* Administration of LMWH or unfractionated heparin before randomization
* Brain tumours, cerebral metastes, hepatic tumours or impairment Child-Pugh B or C, -Recent or current active or life threating bleeding (e.g. intr acranial haemorrhage or gastrointestinal bleeding)
* Thrombocytopenia (platelets \<100 x 109L)
* Severe chronic kidney disease (estimated glomerular filtration rate \<30 ml/minute)
* Pregnant women
20 Years
80 Years
ALL
No
Sponsors
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Beni-Suef University
OTHER
Responsible Party
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Mostafa El Mokadem
Dr
Principal Investigators
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Mostafa E Mokadem
Role: PRINCIPAL_INVESTIGATOR
Faculty of Medicine, Beni-Suef University
Locations
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Faculty of Medicine,Beni-Suef University
Banī Suwayf, Beni Suweif Governorate, Egypt
Countries
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Central Contacts
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Facility Contacts
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Role: backup
References
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Heit JA, Silverstein MD, Mohr DN, Petterson TM, O'Fallon WM, Melton LJ 3rd. Risk factors for deep vein thrombosis and pulmonary embolism: a population-based case-control study. Arch Intern Med. 2000 Mar 27;160(6):809-15. doi: 10.1001/archinte.160.6.809.
Ay C, Beyer-Westendorf J, Pabinger I. Treatment of cancer-associated venous thromboembolism in the age of direct oral anticoagulants. Ann Oncol. 2019 Jun 1;30(6):897-907. doi: 10.1093/annonc/mdz111.
Hutten BA, Prins MH, Gent M, Ginsberg J, Tijssen JG, Buller HR. Incidence of recurrent thromboembolic and bleeding complications among patients with venous thromboembolism in relation to both malignancy and achieved international normalized ratio: a retrospective analysis. J Clin Oncol. 2000 Sep;18(17):3078-83. doi: 10.1200/JCO.2000.18.17.3078.
Prandoni P, Lensing AW, Piccioli A, Bernardi E, Simioni P, Girolami B, Marchiori A, Sabbion P, Prins MH, Noventa F, Girolami A. Recurrent venous thromboembolism and bleeding complications during anticoagulant treatment in patients with cancer and venous thrombosis. Blood. 2002 Nov 15;100(10):3484-8. doi: 10.1182/blood-2002-01-0108. Epub 2002 Jul 12.
Kearon C, Akl EA, Ornelas J, Blaivas A, Jimenez D, Bounameaux H, Huisman M, King CS, Morris TA, Sood N, Stevens SM, Vintch JRE, Wells P, Woller SC, Moores L. Antithrombotic Therapy for VTE Disease: CHEST Guideline and Expert Panel Report. Chest. 2016 Feb;149(2):315-352. doi: 10.1016/j.chest.2015.11.026. Epub 2016 Jan 7.
Konstantinides SV, Meyer G, Becattini C, Bueno H, Geersing GJ, Harjola VP, Huisman MV, Humbert M, Jennings CS, Jimenez D, Kucher N, Lang IM, Lankeit M, Lorusso R, Mazzolai L, Meneveau N, Ni Ainle F, Prandoni P, Pruszczyk P, Righini M, Torbicki A, Van Belle E, Zamorano JL; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS). Eur Heart J. 2020 Jan 21;41(4):543-603. doi: 10.1093/eurheartj/ehz405. No abstract available.
Agnelli G, Buller HR, Cohen A, Gallus AS, Lee TC, Pak R, Raskob GE, Weitz JI, Yamabe T. Oral apixaban for the treatment of venous thromboembolism in cancer patients: results from the AMPLIFY trial. J Thromb Haemost. 2015 Dec;13(12):2187-91. doi: 10.1111/jth.13153. Epub 2015 Oct 29.
McBane RD 2nd, Wysokinski WE, Le-Rademacher JG, Zemla T, Ashrani A, Tafur A, Perepu U, Anderson D, Gundabolu K, Kuzma C, Perez Botero J, Leon Ferre RA, Henkin S, Lenz CJ, Houghton DE, Vishnu P, Loprinzi CL. Apixaban and dalteparin in active malignancy-associated venous thromboembolism: The ADAM VTE trial. J Thromb Haemost. 2020 Feb;18(2):411-421. doi: 10.1111/jth.14662. Epub 2019 Nov 28.
Agnelli G, Becattini C, Bauersachs R, Brenner B, Campanini M, Cohen A, Connors JM, Fontanella A, Gussoni G, Huisman MV, Lambert C, Meyer G, Munoz A, Abreu de Sousa J, Torbicki A, Verso M, Vescovo G; Caravaggio Study Investigators. Apixaban versus Dalteparin for the Treatment of Acute Venous Thromboembolism in Patients with Cancer: The Caravaggio Study. Thromb Haemost. 2018 Sep;118(9):1668-1678. doi: 10.1055/s-0038-1668523. Epub 2018 Aug 13.
Cheung KS, Leung WK. Gastrointestinal bleeding in patients on novel oral anticoagulants: Risk, prevention and management. World J Gastroenterol. 2017 Mar 21;23(11):1954-1963. doi: 10.3748/wjg.v23.i11.1954.
Desai J, Kolb JM, Weitz JI, Aisenberg J. Gastrointestinal bleeding with the new oral anticoagulants--defining the issues and the management strategies. Thromb Haemost. 2013 Aug;110(2):205-12. doi: 10.1160/TH13-02-0150. Epub 2013 May 23. No abstract available.
Desai J, Granger CB, Weitz JI, Aisenberg J. Novel oral anticoagulants in gastroenterology practice. Gastrointest Endosc. 2013 Aug;78(2):227-39. doi: 10.1016/j.gie.2013.04.179. Epub 2013 May 29. No abstract available.
Cannon CP, Kohli P. Danger ahead: watch out for indirect comparisons! J Am Coll Cardiol. 2012 Aug 21;60(8):747-8. doi: 10.1016/j.jacc.2012.05.012. No abstract available.
Mokadem ME, Hassan A, Algaby AZ. Efficacy and safety of apixaban in patients with active malignancy and acute deep venous thrombosis. Vascular. 2021 Oct;29(5):745-750. doi: 10.1177/1708538120971148. Epub 2020 Nov 5.
Other Identifiers
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Apixaban in DVT with cancer
Identifier Type: -
Identifier Source: org_study_id
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