DOAC-CVT: Direct Oral Anticoagulants for the Treatment of Cerebral Venous Thrombosis

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other)

Overall Status

Recruiting

CT.gov ID

NCT04660747

Collaborator

Hospital de Santa Maria, Portugal (Other), Sahlgrenska University Hospital, Sweden (Other), University of Helsinki (Other)

500

Enrollment

Location

Anticipated Duration (Months)

13.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Venous Thrombosis	Drug: Oral anticoagulant

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 1, 2021

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jul 1, 2024

Outcome Measures

Primary Outcome Measures

Composite Outcome: Number of Participants with Major Bleeding and Recurrent VTE [Within 6 months after CVT diagnosis]
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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)