Efficacy and Safety Study of Apixaban for Extended Treatment of Deep Vein Thrombosis or Pulmonary Embolism
Summary
The purpose is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients who have completed their intended treatment for deep vein thrombosis (DVT) or pulmonary embolism (PE)
Timeline
- Start
- 2008-05
- Primary completion
- 2012-08
- Completion
- 2012-08
Outcome
Met primary endpoint
registry Apixaban 2.5 mg vs Placebo; p <0.0001; Risk Ratio (RR) 0.3283 (95% CI 0.2225 to 0.4844) NCT00633893 ↗
registry Apixaban 5 mg vs Placebo; p <0.0001; Risk Ratio (RR) 0.3615 (95% CI 0.2475 to 0.5281) NCT00633893 ↗
registry Apixaban 2.5 mg vs Placebo; p <0.0001; Risk Ratio (RR) 0.2422 (95% CI 0.1476 to 0.3975) NCT00633893 ↗
registry Apixaban 5 mg vs Placebo; p <0.0001; Risk Ratio (RR) 0.1861 (95% CI 0.1062 to 0.3261) NCT00633893 ↗
release “In the AMPLIFY-EXT trial, Eliquis demonstrated a superior reduction in VTE/all-cause death with no statistical difference in major bleeding events vs. placebo” 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.
- Liu X, Thompson J, Phatak H, Mardekian J, Porcari A, Johnson M, Cohen AT. Extended anticoagulation with apixaban reduces hospitalisations in patients with venous thromboembolism. An analysis of the AMPLIFY-EXT trial. Thromb Haemost. 2016 Jan;115(1):161-8. doi: 10.1160/TH15-07-0606. Epub 2015 Oct 8.
- Agnelli G, Buller HR, Cohen A, Curto M, Gallus AS, Johnson M, Porcari A, Raskob GE, Weitz JI; AMPLIFY-EXT Investigators. Apixaban for extended treatment of venous thromboembolism. N Engl J Med. 2013 Feb 21;368(8):699-708. doi: 10.1056/NEJMoa1207541. Epub 2012 Dec 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Apixaban | Small molecule | 2.5 mg | Oral |
| Subject | Apixaban | Small molecule | 5 mg | Oral |