An observational study in Cerebral Venous Thrombosis, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-19.
Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Observational
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 is an international, prospective, comparative cohort study. Initially, DOAC-CVT was designed to recruit 500 patients in a three-year study period. All patients recruited until January 15, 2024 will be included in the primary data analysis as previously described (https://doi.org/10.3389/fneur.2023.1251581). In addition, we will continue patient recruitment in an extension of the study until January 2026 to have a larger sample size, add new research questions, and to further strengthen global. We aim to recruit 1300 patients and anticipating a 3:2 ratio in DOAC:VKA use, we expect that in total 780 patients treated with a DOAC will be included.
Study population: Patients are eligible if they are >18 years old, have a radiologically confirmed CVT, have started oral anticoagulant treatment (DOAC or VKA) within 30 days of CVT diagnosis, and are included in the study within 90 days after 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, benefit and group relatedness: 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.
30 studies on the registry are indexed under Intracranial Thrombosis; 12 are open to participants now.
This study's planned enrollment of 1,300 is above the median of 200 across 17 observational studies indexed under Intracranial Thrombosis.
Browse Intracranial Thrombosis studies →Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 532 studies on the registry; 185 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Consecutive patients with CVT treated at the participating centres. Both patients who are admitted to the hospital and patients who are treated via outpatient clinic are eligible. Centers participating in the DOAC-CVT study keep a log of all patients with CVT presented at their hospital during the study period to register which patients were included in the study and which patients were not eligible for inclusion in the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Drug: Oral anticoagulant
Direct oral anticoagulants or vitamin K antagonists. Please note that the study is fully observational. The choice of anticoagulant type and duration of treatment are left at the discretion of the treating physicians and patients. No treatment, intervention, or examinations are imposed on patients in the context of this study.
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
Time frame: Within 6 months after CVT diagnosis
Mortality Rate
All-cause mortality
Time frame: Within 3, 6, and 12 months after CVT diagnosis
Number of Participants with Recurrent VTE
Symptomatic recurrent venous thromboembolism
Time frame: 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
Time frame: 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
Time frame: Within 3, 6, and 12 months after CVT diagnosis
Number of Participants with Arterial Thrombotic Event
Time frame: 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
Time frame: At 3, 6, and 12 months after CVT diagnosis
Cerebral Venous Recanalization Rate
According to predefined criteria (see study protocol)
Time frame: At 6 months after CVT diagnosis
Frequency of chronic post-CVT symptoms
Outcome added in the extension study
Time frame: At 12 months after CVT diagnosis
Symptomatic recurrent VTE rate
Outcome added in the extension study
Time frame: At 24 months after CVT diagnosis
Documents are hosted by the registry — open the source record to download them.
Started Jan 2021 (actual). Primary completion is estimated for Aug 2024, 43 months after the start.
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