Using direct oral anticoagulants to treat cerebral venous thrombosis
Direct Oral Anticoagulants for the Treatment of Cerebral Venous Thrombosis: An International Phase IV Study
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · NCT04660747
This study is testing whether a new type of blood thinner called direct oral anticoagulants can safely and effectively treat people with cerebral venous thrombosis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (other) |
| Locations | 1 site (Amsterdam, North Holland) |
| Trial ID | NCT04660747 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the safety and efficacy of direct oral anticoagulants (DOACs) in patients diagnosed with cerebral venous thrombosis (CVT). Traditionally, patients have been treated with vitamin K antagonists (VKAs), but DOACs may offer a more practical alternative with a lower risk of complications. The study will include patients who have started anticoagulant treatment within 30 days of their CVT diagnosis and will gather data on their outcomes over time. The goal is to provide additional evidence on the use of DOACs for this condition, building on previous findings from the RESPECT-CVT trial.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with a confirmed diagnosis of cerebral venous thrombosis who have started anticoagulant treatment within 30 days of diagnosis.
Not a fit: Patients who are currently on anticoagulant treatment at the time of CVT diagnosis or have severe renal or liver disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective treatment option for patients with cerebral venous thrombosis.
How similar studies have performed: Previous studies, such as the RESPECT-CVT trial, have shown promising results for the use of DOACs in treating CVT, indicating potential for success in this observational study.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Amsterdam, North Holland
- Jonathan Coutinho — Amsterdam, North Holland, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Jonathan Coutinho, MD, PhD — Amsterdam UMC, location AMC
- Study coordinator: Jonathan Coutinho, MD, PhD
- Email: j.coutinho@amsterdamumc.nl
- Phone: +31205669111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cerebral Venous Thrombosis, Cerebral Venous Sinus Thrombosis, Oral Anticoagulants, Direct Oral Anticoagulants, Vitamin K Antagonists