NCT04660747 Direct Oral Anticoagulants for the Treatment of Cerebral Venous Thrombosis
| NCT ID | NCT04660747 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Condition | Cerebral Venous Thrombosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,300 participants |
| Start Date | 2021-01-27 |
| Primary Completion | 2024-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,300 participants in total. It began in 2021-01-27 with a primary completion date of 2024-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion Criteria: * Written informed consent for the use of observational data * Age \>18 years at the time of CVT diagnosis * 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) * Inclusion in the study within 90 days of CVT diagnosis Exclusion Criteria: * Anticoagulant treatment at the time of CVT diagnosis * Pregnancy or lactation (post-partum women are eligible if they do not give breast-feeding) * Mechanical heart valve * Severe renal insufficiency (defined as an eGFR \<15 ml/min) * Severe liver disease resulting in clinically relevant coagulopathy
Contact & Investigator
Jonathan Coutinho, MD, PhD
PRINCIPAL INVESTIGATOR
Amsterdam UMC, location AMC
Frequently Asked Questions
Who can join the NCT04660747 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cerebral Venous Thrombosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04660747 currently recruiting?
Yes, NCT04660747 is actively recruiting participants. Contact the research team at j.coutinho@amsterdamumc.nl for enrollment information.
Where is the NCT04660747 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT04660747 clinical trial?
NCT04660747 is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The principal investigator is Jonathan Coutinho, MD, PhD at Amsterdam UMC, location AMC. The trial plans to enroll 1,300 participants.