Cerebral vein thrombosis Circulatory System
Conditions
Interventions
Before the study starts, each of the participating centres will be asked whether they have a preference for any of the policy treatment options. If so, they will follow their preferred policy. Centres
Sponsors
Institute of Molecular Medicine (Instituto de Medicina Molecular) (Portugal)
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Any confirmed fatal or nonfatal venous thromboembolic event. The primary outcomes will be measured at 6, 12 and 24 months.These are the compulsory timepoints. However, we also suggest a phone interview at 18 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Recurrent CVT: any new neurological symptom with a new thrombus or occlusion (partial or total) of a cerebral vein or dural sinus and confirmed by repeated conventional CT venography, MRI combined with MR venogram, conventional angiography or surgery, following established diagnostic criteria. 2. Deep vein thrombosis (lower or upper limbs, pelvic or abdominal): acute, symptomatic proximal deep-vein thrombosis of the legs, arms or of any abdominal vein, objectively verified with the use of compression ultrasonography or venography of leg veins or arm veins, CT angiography/venography, MRI combined with angiography/venogram, conventional angiography or at surgery. 3. Pulmonary embolism: acute, symptomatic pulmonary embolism objectively verified with the use of ventilation-perfusion lung scanning, angiography or spiral computed tomography of pulmonary arteries. 4. Arterial thrombotic event (stroke, acute MI, acute arterial limb ischaemia, death proven to be secondary to an arterial vascular event) 5. All thrombotic events (arterial and venous) 6. Death proven to be secondary to a vascular event (arterial or venous), sudden unexplained death (<24 h), nonvascular and death of unknown aetiology The secondary outcomes will be measured at 6, 12 and 24 months.These are the compulsory timepoints. However, we also suggest a phone interview at 18 months. | — |
Countries
Austria, Belgium, Brazil, Denmark, Finland, France, Germany, Greece, India, Italy, Mexico, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland
Outcome results
None listed