EXCOA-CVT study: the benefit of EXtending oral antiCOAgulation treatment after acute Cerebral Vein Thrombosis

Not Applicable

Completed

• Conditions: Cerebral vein thrombosis; Circulatory System

• Registration Number: ISRCTN25644448
• Lead Sponsor: Institute of Molecular Medicine (Instituto de Medicina Molecular) (Portugal)

Brief Summary

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29771211 protocol (added 24/04/2019)

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-10
• Study Completion: 2024-01-01
• Last Update Posted: 10 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1030

Inclusion Criteria

1. Patients with acute symptomatic and radiologically confirmed cerebral vein thrombosis (CVT)
2. Age = 18 years at entry
3. CVT must have been diagnosed in <1 month before inclusion
4. The patient must be clinically stable and able to stop parenteral anticoagulation in order to initiate oral anticoagulation
5. Written informed consent

Exclusion Criteria

1. Systemic life-threatening or major bleeding while on anticoagulants during the acute phase of CVT or during the 6 months prior to randomisation (intracranial bleeding due to inclusion CVT is not an exclusion criteria)
2. General contraindications for anticoagulant therapy
3. Need for prolonged treatment with antiplatelet drugs, non-steroidal anti-inflammatory drugs or other drugs/diseases that interfere significantly with anticoagulant therapy or with INR
4. Life expectancy < 2 years due to a pre-existing condition (including any malignancy)
5. Childbearing potential without adequate contraceptive measures, pregnancy or breastfeeding
6. Known allergy to study medications
7. Other conditions judged by the investigator to be an absolute indication for prolonged oral anticoagulation such as recurrent CVT, venous thromboembolism (VTE) after CVT or first CVT with antiphospholipid syndrome or known severe thrombophilia (antithrombin, protein C or protein S deficiency, homozygous factor V Leiden or prothrombin G20210A mutation or combined abnormalities)

Study & Design

• Study Type: Interventional
• Study Design: Not specified