At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 120 enrolled
Drug / intervention
Dabigatran etexilate +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Dabigatran etexilate and Warfarin for Thromboembolism. Completed, enrolled 120 participants across 36 sites in 9 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsThromboembolism
CountriesFrance, Germany, India, Italy, Netherlands, Poland, Portugal, Russia, Spain
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 2016
Enrollment StartDec 2016
Primary CompletionJun 2018
TodayJul 2026
First PostedSep 23, 2016
Enrollment StartDec 13, 2016
Primary CompletionJun 22, 2018
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 9.8 years ago
Interventions
Dabigatran etexilatedrug
Warfarindrug