Efficacy and Safety of Dabigatran Compared to Warfarin for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
The purpose of this trial is to determine the comparative safety and efficacy of dabigatran
etexilate 150 mg bid administered orally and warfarin as needed (pro re nata - prn) to
maintain an International Normalised Ratio (INR) of 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. This trial aims to demonstrate
non-inferiority of dabigatran compared with warfarin in patients with acute symptomatic VTE.
After achieving non-inferiority, this trial also aims to establish superiority (by means of
hierarchical tests) of dabigatran over warfarin.