Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism
Summary
The purpose of this study is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients with deep vein thrombosis (DVT) or pulmonary embolism (PE)
Timeline
- Start
- 2008-07
- Primary completion
- 2013-03
- Completion
- 2013-03
Outcome
Met primary endpoint
registry analysis (non-inferiority or equivalence test); Apixaban vs Enoxaparin + Warfarin; p <0.0001; Risk Ratio (RR) 0.8390 (95% CI 0.5965 to 1.1802) NCT00643201 ↗
paper Apixaban was noninferior to conventional therapy (P<0.001) for predefined upper limits of the 95% confidence intervals for both relative risk (<1.80) PMID 23808982 ↗
release “overall results of the AMPLIFY trial at 6 months, which demonstrated non-inferiority of Eliquis versus conventional therapy in the primary efficacy endpoint of recurrent VTE” bms.com ↗
release “AMPLIFY trial at 6 months, which demonstrated non-inferiority of Eliquis versus conventional therapy in the primary efficacy endpoint” pfizer.com ↗
release “Eliquis demonstrated noninferiority in the primary efficacy endpoint of recurrent symptomatic venous thromboembolism (VTE) or VTE-related death versus enoxaparin/warfarin in the AMPLIFY trial” bms.com ↗
Publications
- Jamieson MJ, Byon W, Dettloff RW, Crawford M, Gargalovic PS, Merali SJ, Onorato J, Quintero AJ, Russ C. Apixaban Use in Obese Patients: A Review of the Pharmacokinetic, Interventional, and Observational Study Data. Am J Cardiovasc Drugs. 2022 Nov;22(6):615-631. doi: 10.1007/s40256-022-00524-x. Epub 2022 May 16.
- Cohen AT, Pan S, Byon W, Ilyas BS, Taylor T, Lee TC. Efficacy, Safety, and Exposure of Apixaban in Patients with High Body Weight or Obesity and Venous Thromboembolism: Insights from AMPLIFY. Adv Ther. 2021 Jun;38(6):3003-3018. doi: 10.1007/s12325-021-01716-8. Epub 2021 Apr 22.
- Cohen AT, Agnelli G, Buller HR, Gallus A, Raskob GE, Sanders P, Thompson J, Weitz JI. Characteristics and Outcomes in Patients with Venous Thromboembolism Taking Concomitant Anti-Platelet Agents and Anticoagulants in the AMPLIFY Trial. Thromb Haemost. 2019 Mar;119(3):461-466. doi: 10.1055/s-0038-1676983. Epub 2019 Jan 16.
- Liu X, Johnson M, Mardekian J, Phatak H, Thompson J, Cohen AT. Apixaban Reduces Hospitalizations in Patients With Venous Thromboembolism: An Analysis of the Apixaban for the Initial Management of Pulmonary Embolism and Deep-Vein Thrombosis as First-Line Therapy (AMPLIFY) Trial. J Am Heart Assoc. 2015 Dec 1;4(12):e002340. doi: 10.1161/JAHA.115.002340.
- Agnelli G, Buller HR, Cohen A, Curto M, Gallus AS, Johnson M, Masiukiewicz U, Pak R, Thompson J, Raskob GE, Weitz JI; AMPLIFY Investigators. Oral apixaban for the treatment of acute venous thromboembolism. N Engl J Med. 2013 Aug 29;369(9):799-808. doi: 10.1056/NEJMoa1302507. Epub 2013 Jul 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Apixaban | Small molecule | 5 mg | Oral |
| Comparator | Enoxaparin sodium | Other / unclassified | 1 mg/kg | Subcutaneous |
| Comparator | Warfarin | Small molecule | — | Oral |