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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
Jonathan Coutinho
RECRUITING
Amsterdam
Contact Information
Primary
Jonathan Coutinho, MD, PhD
j.coutinho@amsterdamumc.nl
+31205669111
Time Frame
Start Date: 2021-01-27
Estimated Completion Date: 2028-01
Participants
Target number of participants: 1300
Treatments
CVT cohort
Related Therapeutic Areas
Sponsors
Collaborators: Centro Hospitalar de Lisboa Central, University of Lisbon, University of Helsinki, Sahlgrenska University Hospital
Leads: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

This content was sourced from clinicaltrials.gov