Health Condition 1: I636- Cerebral infarction due to cerebral venous thrombosis, nonpyogenic
Conditions
Interventions
Intervention1: Long-Term Oral Anticoagulation Arm (6 Months): Long-Term Oral Anticoagulation Arm (6 Months): Participants in this arm will also receive initial anticoagulation therapy with either subc
Sponsors
AIIMS Rishikesh
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with acute symptomatic and radiologically confirmed cerebral vein thrombosis (CVT). 2. CVT must have been diagnosed within 1 month before inclusion. 3. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. General contraindications for anticoagulant therapy. 2. 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 assessment. 3. Life expectancy less than 2 years due to a pre-existing condition (including any malignancy). 4. Known allergy to study medications. 5. 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 |
|---|---|
| The Primary efficacy outcome will be composite of Venous Thromboembolic Events (DVT, PE and recurrent CVT) at 12 months.Timepoint: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Recanalization rate at 3 months and 6 months of anticoagulation therapy as assessed by MRI Angiography.Timepoint: 3 month and 6 month;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 at 12 months.Timepoint: 12 month;Pulmonary embolism: acute, symptomatic pulmonary embolism objectively verified with the use of ventilation-perfusion lung scanning, angiography or spiral computed tomography of pulmonary arteries at 12 months.Timepoint: 12 month;Arterial thrombotic event (stroke, acute MI, acute arterial limb ischaemia, death proven to be secondary to an arterial vascular event) at 12 months.Timepoint: 12 month;Death proven to be secondary to a vascular event (arterial or venous), sudden unexplained death (within 24 hour), nonvascular and death of unknown aetiology at 12 monthsTimepoint: 12 month;Functional outcome measured by Modified Rankin Scale (mRS-Score) at 3, 6 and 12 months.Timepoint: 3 month, 6 month and 12 month;Safety Outcome minor and major Haemorrhage -rate of haemorrhagic stroke, symptomatic intracerebral haemorrhage or other symptomatic intracranial and extracranial haemorrhage like upper GI bleed etcTimepoint: 3 month, 6 month, 12 month | — |
Countries
India
Contacts
Public ContactMritunjai Kumar
AIIMS Rishikesh
Outcome results
None listed