Phase 3
N=120
A Clinical Trial Comparing Efficacy and Safety of Dabigatran Etexilate With Warfarin in Patients With Cerebral Venous and Dural Sinus Thrombosis (RE-SPECT CVT)
Thromboembolism
Bottom Line
View on ClinicalTrials.gov: NCT02913326 ↗Enrolled (actual)
120
Serious AEs
11.7%
Results posted
Aug 2019
Primary outcome: Primary: Percentage of Participants With Composite of Venous Thrombotic Event (VTE) or Major Bleeding Event (MBE) According to International Society on Thrombosis and Haemostasis (ISTH) Criteria in Full Observation Period. — 1.7; 3.3 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dabigatran etexilate (Drug); Warfarin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Composite of Venous Thrombotic Event (VTE) or Major Bleeding Event (MBE) According to International Society on Thrombosis and Haemostasis (ISTH) Criteria in Full Observation Period. |
1.7; 3.3 | — |
| SECONDARY Percentage of Participants With Recurring Cerebral Venous and Dural Sinus Thrombosis; DVT of Any Limb, PE or Splanchnic Vein Thrombosis in Full Observation Period |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Cerebral Venous Recanalisation as Measured by the Change in Number of Occluded Cerebral Veins and Sinuses at Week 24 |
-0.8; -1.0 | — |
| SECONDARY Percentage of Participants With Major Bleeding According to ISTH Criteria in Full Observation Period |
1.7; 3.3 | — |
| SECONDARY Composite Endpoint of Percentage of Participants With New Intracranial Haemorrhage or Worsening of the Haemorrhagic Component of a Previous Lesion After up to 24 Weeks |
1.8; 3.8 | — |
| SECONDARY Percentage of Participants With Clinically Relevant Non-major Bleeding Events in Full Observation Period. |
0.0; 1.7 | — |
| SECONDARY Percentage of Participants With Major Bleeding According to ISTH Criteria or CRNMBEs After up to 24 Weeks |
1.7; 5.0 | — |
| SECONDARY Percentage of Participants With Any Bleeding Event After up to 24 Weeks |
20.0; 20.0 | — |
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.
Eligibility Criteria
Inclusion criteria
- Written informed consent in accordance with International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines and local legislation and/or regulations
- Confirmed diagnosis of Cerebral Venous or dural sinus thrombosis (CVT), with or without intracranial haemorrhage
- Completion of anticoagulation therapy for 5-15 days which has been administered until randomisation; anticoagulation must include full-dose low molecular weight heparin or unfractionated heparin
- Eligibility for treatment with an oral anticoagulant
- Further inclusion criteria apply
Exclusion criteria
- Cerebral Venous or dural sinus thrombosis (CVT) associated with central nervous system infection or due to head trauma
- Planned surgical treatment for CVT
- Conditions associated with increased risk of bleeding
- History of symptomatic non-traumatic intracranial haemorrhage with risk of recurrence according to Investigator judgment
- Treatment with an antithrombotic regimen for an indication other than CVT and requiring continuation of that treatment for the original diagnosis without change in the regimen
- Severe renal impairment
- Active liver disease
- Pregnancy, nursing or planning to become pregnant while in the trial
- Further exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT02913326). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.