Urology - The Gold Journal

Apixaban: AMPLIFY Study Design

Turning to the AMPLIFY study with apixaban, a total of 4816 patients with DVT or PE were enrolled into a single study (Figure 13).[11]  The comparator was the classic therapy of enoxaparin followed by a vitamin K antagonist.  AMPLIFY was a double-blind trial, very similar to the EINSTEIN studies in that it employed the same single-drug approach.  Apixaban was given at a dose of 10 mg bid for the first week, followed by a dose reduction to 5 mg.  The primary efficacy outcome was symptomatic recurrent VT or VTE-related death, identical to the previous studies, but the safety outcome was bleeding during study treatment.   Buller HR. Am J Med 2013; published on-line at http://education.amjmed.com/00000.

References

[11] Protocol for: Agnelli G, Buller HR, Cohen A, et al; AMPLIFY Investigators. Oral apixaban for the treatment of acute venous thromboembolism. N Engl J Med. 2013;369:799-808. http://www.nejm.org/action/showSupplements?doi=10.1056%2FNEJMoa1302507&viewType=Popup&viewClass=Suppl