Direct Oral Anticoagulants for the Treatment of Cerebral Venous Thrombosis

Study Overview
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Brief Summary
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Rationale: Patients with cerebral venous thrombosis (CVT) are currently treated with anticoagulants during 3-12 months after diagnosis, to prevent worsening of the CVT and recurrent thrombosis, and to promote venous recanalization. Until recently, patients were generally treated with vitamin K antagonists (VKA). Direct oral anticoagulants (DOACs) are more practical in use than VKA and carry a lower risk of intracranial hemorrhage (ICH) in other conditions. One of the burning clinical questions is whether CVT patients can be safely treated with DOACs instead of VKA. In 2019, the first randomized trial on the safety and efficacy of DOACs in CVT was published (RESPECT-CVT). This exploratory study included 120 patients and the results suggest that DOACs can be safely used to treat CVT. Following RESPECT-CVT, use of DOACs to treat CVT is expected to rise, but given the limited sample size and strict selection criteria of RESPECT-CVT, additional data regarding the efficacy and safety of DOACs in CVT are required, especially from routine clinical care. Objective: To assess the safety and efficacy of DOACs for the treatment of CVT in a real-world setting. Study design: DOAC-CVT will be an international, prospective, comparative cohort study. We aim to recruit 500 patients and anticipating a 3:2 ratio in DOAC:VKA use, we expect that in total 300 patients treated with a DOAC will be included. Study population: Patients are eligible if they are >18 years old, have a radiologically confirmed CVT, and have started oral anticoagulant treatment (DOAC or VKA) within 30 days of CVT diagnosis. Primary study endpoint: The primary endpoint is a composite of major bleeding (according to the criteria of the International Society on Thrombosis and Haemostasis) AND symptomatic recurrent venous thrombosis after 6 months of follow-up. Nature and extent of the burden and risks associated with participation: This is an observational study which poses no risk or burden to the participant. Only data that are collected as part of routine clinical care will be used.

Official Title
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Direct Oral Anticoagulants for the Treatment of Cerebral Venous Thrombosis: An International Phase IV Study

Conditions
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Cerebral Venous Thrombosis

Intervention / Treatment
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* Drug: Oral anticoagulant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent for the use of observational data Radiologically confirmed CVT diagnosis (CT-venography, MRI or catheter angiography) Oral anticoagulant treatment (DOAC or VKA) started within 30 days of CVT diagnosis (patient may initially be treated with heparin) Exclusion Criteria: Pregnancy or lactation Mechanical heart valve Severe renal insufficiency (defined as an eGFR <15 ml/min) Severe liver disease resulting in clinically relevant coagulopathy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Oral anticoagulant|Direct oral anticoagulants or vitamin K antagonists|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Outcome: Number of Participants with Major Bleeding and Recurrent VTE | Major bleeding is defined according to the criteria of the International Society on Thrombosis and Haemostasis. Recurrent VTE is defined as symptomatic recurrent venous thromboembolism | Within 6 months after CVT diagnosis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality Rate | All-cause mortality | Within 3, 6, and 12 months after CVT diagnosis | 
| Number of Participants with Recurrent VTE | Symptomatic recurrent venous thromboembolism | Within 3, 6, and 12 months after CVT diagnosis | 
| Number of Participants with Major Bleeding | According to the criteria of the International Society on Thrombosis and Haemostasis | Within 3, 6, and 12 months after CVT diagnosis | 
| Number of Participants with Clinically Relevant Non-Major Bleeding | According to the criteria of the International Society on Thrombosis and Haemostasis | Within 3, 6, and 12 months after CVT diagnosis | 
| Number of Participants with Arterial Thrombotic Event |  | Within 3, 6, and 12 months after CVT diagnosis | 
| Modified Rankin Scale | Scale ranges from 0 to 6, with higher scores indicating worse functional outcome | At 3, 6, and 12 months after CVT diagnosis | 
| Cerebral Venous Recanalization Rate | According to predefined criteria (see study protocol) | At 6 months after CVT diagnosis | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebral Venous Thrombosis, Cerebral Venous Sinus Thrombosis, Oral Anticoagulants, Direct Oral Anticoagulants, Vitamin K Antagonists