Cerebral vein thrombosis: anticoagulation trial protocol

What is it about?

As part of the International Study on Cerebral Vein and Dural Sinus Thrombosis (ISCVT2) project, the Benefit of EXtending oral antiCOAgulant treatment after Cerebral Vein and Dural Sinus Thrombosis (EXCOA-CVT) is a prospective study with a cluster randomised allocation design that aims to compare a policy of short (3 to 6 months) versus long term (12 months) oral anticoagulation in the prevention of VTEs after an episode of CVT. Participating centres are asked whether they have preference for any of the policy treatment options and centres with no preference will be randomly allocate for one of the two options. Centres with a preference will still participate as part of an observational study. Eligible patients will be treated according to the approach allocated to their centre as soon as their acute clinical situation is stable and not more than 1 month after the CVT diagnosis. Follow-up will be performed at 6, 12, 18 (telephone-interview) and 24 months from the date of entry. The primary efficacy outcome is any symptomatic and confirmed VTE (recurrent CVT or other systemic VTE) or death associated with venous thromboembolism. Primary safety endpoints include bleeding events, classified as major/minor and according to the site of bleeding, and death from any cause.

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Why is it important?

Cerebral vein and Dural Sinus thrombosis (CVT) is a rare type of cerebrovascular disease that affects most often young people and with potentially disabling or fatal consequences. Despite the increasing awareness of the condition, the risk of a venous thromboembolic recurrence and its prevention received little attention. There is enough uncertainty to justify a trial to assess the optimal duration of anticoagulation after acute CVT. This cluster-randomized trial aims to compare the efficacy and safety of short- (3–6 months) versus long-term (12 months) anticoagulation for the prevention of VTEs after an episode of CVT, with a total 24-month follow-up period.

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