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

NCT02913326 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2019-08-15

Study results available
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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

DRUG

Dabigatran etexilate

DRUG

Warfarin

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
78 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-13
Primary Completion
2018-06-22
Completion
2018-06-22

Countries

  • France
  • Germany
  • India
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Russia
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02913326 on ClinicalTrials.gov