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: 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

NL-OMON

Registry ID

NL-OMON45785

Enrollment

Registered

2017-05-09

Start date

2017-02-03

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

cerebral venous and durale sinustrombosis

Interventions

See protocol sectie 4.1 t/m 4.4

dabigatran etexilate

efficacy

safety

sinustrombosis

Eligibility

Age

18 Years to 64 Years

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

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 judgement;- 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

Design outcomes

Primary

Measure	Time frame
See protocol sectie 5.1.1.	—

Secondary

Measure	Time frame
See protocol sectie 5.1.2 & 5.1.3	—

Countries

France, Germany, India, Italy, Netherlands, Poland, Portugal, Russian Federation, Spain

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)