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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 C

Brief 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.

Detailed Summary:
Sponsor: Boehringer Ingelheim

Current Primary Outcome: Composite of the number of patients with major bleeding according to ISTH criteria and Venous Thrombotic Event (VTE) (recurring CVT; deep venous thrombosis of any limb, pulmonary embolism, splanchnic vein thrombosis) after up to 24 weeks [ Time Frame: up to 24 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Cerebral venous recanalisation as measured by the change in number of occluded cerebral veins and sinuses after up to 24 weeks [ Time Frame: up to 24 weeks ]
  • Number of patients with any bleeding event after up to 24 weeks [ Time Frame: up to 24 weeks ]
  • Number of patients with recurring cerebral venous and dural sinus thrombosis; deep venous thrombosis of any limb, pulmonary embolism or splanchnic vein thrombosis after up to 24 weeks [ Time Frame: up to 24 weeks ]
  • Number of patients with major bleeding according to International Society on Thrombosis and Haemostasis criteria after up to 24 weeks [ Time Frame: up to 24 weeks ]
  • Composite endpoint of number of patients with new Intracranial haemorrhage or worsening of the haemorrhagic component of a previous lesion after up to 24 weeks [ Time Frame: up to 24 weeks ]
  • Number of patients with clinically relevant non-major bleeding events after up to 24 weeks [ Time Frame: up to 24 weeks ]
  • Number of patients with major bleeding according to International Society on Thrombosis and Haemostasis criteria or clinically relevant non-major bleeding events after up to 24 weeks [ Time Frame: up to 24 weeks ]


Original Secondary Outcome: Same as current

Information By: Boehringer Ingelheim

Dates:
Date Received: September 21, 2016
Date Started: December 13, 2016
Date Completion: April 20, 2018
Last Updated: May 15, 2017
Last Verified: May 2017