Thromb Haemost 2017; 117(02): 415-421
DOI: 10.1160/TH16-07-0566
Trial Protocol Design Paper
Schattauer GmbH

RE-COVERY DVT/PE: Rationale and design of a prospective observational study of acute venous thromboembolism with a focus on dabigatran etexilate

Walter Ageno
1  University of Insubria, Varese, Italy
,
Ivan B. Casella
2  University of Sao Paulo, Sao Paulo, Brazil
,
Chee Kok Han
3  University of Malaya, Kuala Lumpur, Malaysia
,
Gary E. Raskob
4  University of Oklahoma Health Sciences Center, Oklahoma, USA
,
Sebastian Schellong
5  Stadtisches Klinikum Dresden, Dresden, Germany
,
Sam Schulman
6  Thrombosis and Atherosclerosis Research Institute and McMaster University, Hamilton, Ontario, Canada
,
Daniel E. Singer
7  Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA
,
Karen Kimura
8  Boehringer Ingelheim Canada, Burlington, Ontario, Canada
,
Wenbo Tang
9  Boehringer Ingelheim, Germany
,
Marc Desch
9  Boehringer Ingelheim, Germany
,
Samuel Z. Goldhaber
10  Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts, USA
› Author Affiliations
Further Information

Publication History

Received:23 July 2016

Accepted:14 October 2016

Publication Date:
01 December 2017 (online)

Summary

The therapeutic management of venous thromboembolism (VTE) is rapidly evolving. Following the positive results of pivotal large-scale randomised trials, the non-vitamin K antagonist oral anticoagulants (NOACs) represent an important alternative to standard anticoagulation. In phase III studies, dabigatran was as effective as, and significantly safer than warfarin. Additional information on real-world data of dabigatran is now warranted. RE-COVERY DVT/PE is a multi-centre, international, observational (i. e. non-interventional) study enrolling patients with acute DVT and/or PE within 30 days after objective diagnosis. The study is designed with two phases. Phase 1 has a cross-sectional design, enrolling approximately 6000 patients independently of treatment choice, with the aim of providing a contemporary picture of the management of VTE worldwide. Phase 2 has a prospective cohort design, with follow-up of one year, enrolling 8000 patients treated with dabigatran or vitamin K antagonists (VKAs) with the aim of comparing their safety, defined by the occurrence of major bleeding, and effectiveness, defined by the occurrence of symptomatic recurrent VTE. RE-COVERY DVT/PE will complement both the results of other observational studies in this field and the results of phase III studies with dabigatran, in particular by assessing its clinical benefit in various patient subgroups treated in routine clinical practice.