Health Condition 1: null- patients with cerebral venous sinus thrombosis,within month of event
Conditions
Interventions
None listed
Sponsors
University of Lisbon
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients with acute symptomatic and radiologically confirmed CVT ï? 2.Age 18 years OR above at entry ï? 3.CVT must have been diagnosed in less than 1 month before inclusion ï? 4.The patient must be clinically stable and able to stop parenteral anticoagulation in order to initiate oral anticoagulation ï? ï?¡ 5.Written informed consent
Exclusion criteria
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) ï? ï?¡ 2.General contraindications for anticoagulant therapy ï? 3.Need for prolonged treatment with antiplatelet drugs, non-steroidal anti-inflammatory drugs or other drugs/diseases that interferes significantly with anticoagulant therapy or with INR ï? ï?¡ 4.Life expectancy less than 2 years due to a pre-existing condition (including any malignancy) ï? 5.Child bearing potential without adequate contraceptive measures, pregnancy or breast feeding ï? 6.Known allergy to study medications ï? 7.Other conditions judged by the investigator to be an absolute indication for prolonged oral anticoagulation such as recurrent CVT, 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Any confirmed fatal or nonfatal venous thromboembolic eventTimepoint: at 6,12,18 and 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes-look for 1.Recurrent CVT ï? 2.other deep vein thrombosis. 3.Pulmonary embolism ï? 4.Arterial thrombotic event (stroke, acute myocardial infarction, acute arterial limb ischaemia, death proven to be secondary to an arterial vascular event) ï? 5.All thrombotic events (arterial and venous) ï? 6.Death proven to be secondary to a vascular event (arterial or venous), sudden unexplained death (24h), nonvascular and death of unknown aetiologyTimepoint: upto 24 months from the index event | — |
Countries
Canada, China, India, Portugal, United Kingdom, United States of America
Contacts
Public ContactP N Sylaja
Sree Chitra Tirunal Institute for Medical Sciences and Technology
Outcome results
None listed