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 - RE-SPECT CVT

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-004412-38-PT

Enrollment

180

Registered

2016-08-23

Start date

2017-01-09

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cerebral vein and dural sinus thrombosis MedDRA version: 19.1 Level: HLT Classification code 10008209 Term: Cerebrovascular venous and sinus thrombosis System Organ Class: 100000004852

Interventions

Trade Name: Pradaxa Product Name: dabigatran etexilate, 150 mg Product Code: BIBR 1048 MS Pharmaceutical Form: Capsule, hard INN or Prop

Eligibility

Sex/Gender

All

Inclusion 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 weigth heparin or unfractionated heparin - Eligibility for treatment with an oral anticoagulant Further inclusion criteria apply Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 165 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

Exclusion criteria: - 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 before CVT diagnosis and requiring continuation of that treatment for the original diagnosis without change in the regimen - Severe renal impairment - Active liver disease - Preganancy, nursing or planning to become pregnant while in the trial Further exclusion criteria apply

Design outcomes

Primary

Measure	Time frame
Main Objective: to compare net clinical benefit of the treatment arms, as measured by the composite of venous thrombotic events (VTE) (recurring CVT, deep venous thrombosis (DVT) of any limb, pulmonary embolism (PE), or splanchnic vein thrombosis) + major bleeding according to ISTH criteria;Secondary Objective: Secondary objectives include a comparison of additional efficacy and safety parameters; Primary end point(s): 1: Composite of the number of patients with major bleeding according to ISTH criteria and Venous Thrombotic Event (VTE) (recurring CVT; deep venous thrombosis (DVT) of any limb, pulmonary embolism (PE), splanchnic vein thrombosis) after up to 24 weeks ; Timepoint(s) of evaluation of this end point: 1: up to 24 weeks	—

Measure

Time frame

Main Objective: to compare net clinical benefit of the treatment arms, as measured by the composite of venous thrombotic events (VTE) (recurring CVT, deep venous thrombosis (DVT) of any limb, pulmonary embolism (PE), or splanchnic vein thrombosis) + major bleeding according to ISTH criteria;Secondary Objective: Secondary objectives include a comparison of additional efficacy and safety parameters; Primary end point(s): 1: Composite of the number of patients with major bleeding according to ISTH criteria and Venous Thrombotic Event (VTE) (recurring CVT; deep venous thrombosis (DVT) of any limb, pulmonary embolism (PE), splanchnic vein thrombosis) after up to 24 weeks ; Timepoint(s) of evaluation of this end point: 1: up to 24 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): 1: Number of patients with recurring CVT; DVT of any limb, PE or splanchnic vein thrombosis after up to 24 weeks 2: Cerebral venous recanalisation as measured by the change in number of occluded cerebral veins and sinuses after up to 24 weeks 3: Number of patients with major bleeding according to ISTH criteria after up to 24 weeks 4: Composite endpoint of number of patients with new ICH or worsening of the haemorrhagic component of a previous lesion after up to 24 weeks 5: Number of patients with clinically relevant non-major bleeding events (CRNMBE) after up to 24 weeks 6: Number of patients with major bleeding according to ISTH criteria or CRNMBE after up to 24 weeks 7: Number of patients with any bleeding event after up to 24 weeks ; Timepoint(s) of evaluation of this end point: 1: up to 24 weeks 2: up to 24 weeks 3: up to 24 weeks 4: up to 24 weeks 5: up to 24 weeks 6: up to 24 weeks 7: up to 24 weeks	—

Measure

Time frame

Secondary end point(s): 1: Number of patients with recurring CVT; DVT of any limb, PE or splanchnic vein thrombosis after up to 24 weeks 2: Cerebral venous recanalisation as measured by the change in number of occluded cerebral veins and sinuses after up to 24 weeks 3: Number of patients with major bleeding according to ISTH criteria after up to 24 weeks 4: Composite endpoint of number of patients with new ICH or worsening of the haemorrhagic component of a previous lesion after up to 24 weeks 5: Number of patients with clinically relevant non-major bleeding events (CRNMBE) after up to 24 weeks 6: Number of patients with major bleeding according to ISTH criteria or CRNMBE after up to 24 weeks 7: Number of patients with any bleeding event after up to 24 weeks ; Timepoint(s) of evaluation of this end point: 1: up to 24 weeks 2: up to 24 weeks 3: up to 24 weeks 4: up to 24 weeks 5: up to 24 weeks 6: up to 24 weeks 7: up to 24 weeks

—

Countries

Belgium, Canada, France, Germany, India, Italy, Netherlands, Norway, Poland, Portugal, Russian Federation, Spain

Contacts

Public ContactQRPE PSC CT Information Disclosure

Boehringer Ingelheim International GmbH

clintriage.rdg@boehringer-ingelheim.com+18002430127

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026