NCT02913326

A Clinical Trial Comparing Efficacy and Safety of Dabigatran Etexilate With Warfarin in Patients With Cerebral Venous and Dural Sinus Thrombosis (RE-SPECT CVT)

RE-SPECT CVT: a Randomised, Open-label, Exploratory Trial With Blinded Endpoint Adjudication (PROBE), Comparing Efficacy and Safety of Oral Dabigatran Etexilate Versus Oral Warfarin in Patients With Cerebral Venous and Dural Sinus Thrombosis Over a 24-week Period

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 78 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, prospective, international, randomized (1:1), open-label study with two parallel groups. This phase III study is planned to investigate the efficacy and safety of dabigatran etexilate versus dose-adjusted warfarin on a net clinical benefit endpoint of major bleeding (ISTH criteria) and new venous thrombotic event (VTE) (primary endpoint) with blinded endpoint adjudication.

Conditions

• Thromboembolism

Interventions

Type	Name	Description
DRUG	Dabigatran etexilate
DRUG	Warfarin

Timeline

• Start date: 2016-12-13
• Primary completion: 2018-06-22
• Completion: 2018-06-22
• First posted: 2016-09-23
• Last updated: 2019-08-15
• Results posted: 2019-08-15

Locations

36 sites across 9 countries: France, Germany, India, Italy, Netherlands, Poland, Portugal, Russia, Spain