A multicentre, multinational study with a randomised cluster allocation design comparing the efficacy and safety of short (3-6 months) versus long-term (12 months) oral anticoagulation for the prevention of venous thromboembolic events after an episode of cerebral vein thrombosis

Institute of Molecular Medicine (Instituto de Medicina Molecular) (Portugal)0 sites1,030 target enrollmentApril 10, 2014

Overview

Phase: 未知
Intervention: Not specified
Conditions: Not specified
Sponsor: Institute of Molecular Medicine (Instituto de Medicina Molecular) (Portugal)
Enrollment: 1030
Status: Completed
Last Updated: last year

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

Registry

who.int

Start Date

April 10, 2014

End Date

January 1, 2024

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

Institute of Molecular Medicine (Instituto de Medicina Molecular) (Portugal)

•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

•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)