Trial Profile
A Phase III, Randomised, Double Blind, Parallel-group Study of the Efficacy and Safety of Oral Dabigatran Etexilate 150 mg Twice Daily Compared to Warfarin (INR 2.0-3.0) for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism (VTE), Following Initial Treatment (5-10 Days) With a Parenteral Anticoagulant Approved for This Indication
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 19 Jan 2022
Price :
$35
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At a glance
- Drugs Dabigatran etexilate (Primary) ; Warfarin
- Indications Deep vein thrombosis; Pulmonary embolism; Thromboembolism; Venous thromboembolism
- Focus Registrational; Therapeutic Use
- Acronyms RE-COVER; RE-COVER-I; RE-VOLUTION
- Sponsors Boehringer Ingelheim Pharmaceuticals
- 01 Sep 2020 Results of meta analysis determining the efficacy and safety of NOACs vs. VKAs in patients with different age, sex and renal function for the treatment of VTE presented at the ESC Congress 2020 - Annual Congress of the European Society of Cardiology
- 05 Jul 2018 Results (n=1280) of a pooled post-hoc analysis of two RE- COVER and RE-MEDY trials, were published in the Journal of Thrombosis and Haemostasis.
- 04 Oct 2017 Results (n=5107) of post hoc subgroup analyses of pooled data from the RE-COVER-I and RE-COVER-II trials assessing effects of old age and renal impairment on efficacy and safety of dabigatran versus warfarin published in the Thrombosis and Haemostasis