Secondary Prevention of Venous Thrombo Embolism (VTE).
Summary
The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate administered orally and warfarin (International Normalized Ratio (INR) of 2.0-3.0) for the long-term treatment and secondary prevention of symptomatic venous thromboembolism in patients who have been successfully treated with standard doses of an approved anticoagulant for three to twelve months for confirmed acute symptomatic Venous Thrombo-embolism.
Timeline
- Start
- 2006-05
- Primary completion
- 2010-10
- Completion
- —
Outcome
Met primary endpoint
registry analysis (non-inferiority or equivalence test); Dabigatran vs Warfarin; p = 0.0137; Hazard Ratio (HR) 1.44 (95% CI 0.78 to 2.64) NCT00329238 ↗
registry analysis (non-inferiority or equivalence test); Dabigatran vs Warfarin; p <0.0001; Risk Difference (RD) 0.38 (95% CI -0.50 to 1.25) NCT00329238 ↗
release “RE-MEDY demonstrated that treatment with dabigatran 150 mg twice daily was non-inferior to warfarin (p=0.01) in preventing recurrent VTE, including VTE-related death.” prnewswire.com ↗
Publications
- Goldhaber SZ, Eriksson H, Kakkar A, Schellong S, Feuring M, Fraessdorf M, Kreuzer J, Schueler E, Schulman S. Efficacy of dabigatran versus warfarin in patients with acute venous thromboembolism in the presence of thrombophilia: Findings from RE-COVER(R), RE-COVER II, and RE-MEDY. Vasc Med. 2016 Dec;21(6):506-514. doi: 10.1177/1358863X16668588. Epub 2016 Nov 1.
- Majeed A, Hwang HG, Connolly SJ, Eikelboom JW, Ezekowitz MD, Wallentin L, Brueckmann M, Fraessdorf M, Yusuf S, Schulman S. Management and outcomes of major bleeding during treatment with dabigatran or warfarin. Circulation. 2013 Nov 19;128(21):2325-32. doi: 10.1161/CIRCULATIONAHA.113.002332. Epub 2013 Sep 30.
- Schulman S, Kearon C, Kakkar AK, Schellong S, Eriksson H, Baanstra D, Kvamme AM, Friedman J, Mismetti P, Goldhaber SZ; RE-MEDY Trial Investigators; RE-SONATE Trial Investigators. Extended use of dabigatran, warfarin, or placebo in venous thromboembolism. N Engl J Med. 2013 Feb 21;368(8):709-18. doi: 10.1056/NEJMoa1113697.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dabigatran | Unknown | 150 mg | Oral |
| Comparator | Warfarin | Small molecule | — | Oral |