Direct Oral Anticoagulants for the Treatment of Cerebral Venous Thrombosis

Cerebral Venous Thrombosis Clinical Trial

— DOAC-CVT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04660747
• Other study ID #: DOAC-CVT
• Status: Recruiting
• Start date: May 1, 2021
• Est. completion date: July 2024

Study information

• Verified date: February 2022
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Jonathan Coutinho, MD, PhD
• Phone: +31205669111
• Email: j.coutinho[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Exclusion Criteria:

• Pregnancy or lactation
• Mechanical heart valve
• Severe renal insufficiency (defined as an eGFR <15 ml/min)
• Severe liver disease resulting in clinically relevant coagulopathy

Related Conditions & MeSH terms

• Cerebral Venous Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• Oral anticoagulant
Direct oral anticoagulants or vitamin K antagonists

Locations

Country	Name	City	State
Netherlands	Jonathan Coutinho	Amsterdam	Noord-Holland

Sponsors (4)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Hospital de Santa Maria, Portugal, Sahlgrenska University Hospital, Sweden, University of Helsinki

Country where clinical trial is conducted

Netherlands, 

Outcome

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