Clinical trial · Interventional
Efficacy of Apixaban in Malignancy With Deep Venous Thrombosis
Efficacy and Safety of Apixaban in Patients With Active Malignancy and Acute Deep Venous Thrombosis.
NCT04462003CI-TRIAL-00045837DVTunknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of study was to evaluate the efficacy and safety of Apixaban in patients with acute deep venous thrombosis and active malignancy compared with weight adjusted subcutaneous (LMWH). It was hypothesised that Apixaban could be as effective as rivaroxiban and edoxaban in treatment of patients with acute DVT and active malignancy with a lower risk of bleeding especially in those with GIT cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Deep Vein Thrombosis | — | UNRESOLVED | — |
| Malignancy | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apixaban | Drug | — | UNRESOLVED |
| Enoxaparin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Apixaban
- description
- 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
- interventionNames
- Drug: Apixaban
- type
- ACTIVE_COMPARATOR
- label
- Enoxaparin
- description
- 50 patients with DVT with malignancy were randomized to enoxaparin (1mg/Kg/SC every 12 h)
- interventionNames
- Drug: Enoxaparin
Primary outcomes (3)
- measure
- Recurrent deep venous thrombosis or venous thromboembolism
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria Patients with active malignancy presenting with acute deep venous thrombosis and still treated with chemotherapy Exclusion Criteria: * Patients with pulmonary embolism and hemodynamic instability requiring thrombolytic therapy * 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
References
Publications (14)
- RESULTHeit 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. PMID 10737280
- RESULTAy 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. PMID 30918939
- RESULTHutten 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. PMID 10963635
- RESULTPrandoni 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. PMID 12393647
- RESULTKearon 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. PMID 26867832
- RESULTKonstantinides 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.