Comparison of efficacy and saftey of short term versus long term oral anticoagulation for the prevention of Venous Thrombotic Events After an Episode of Acute Cerebral Venous thrombosis: An Open Label Randomized Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The Primary efficacy outcome will be composite of Venous Thromboembolic Events (DVT, PE and recurrent CVT) at 12 months.
研究概览
简要总结
Cerebral vein thrombosis (CVT) is a rare but serious condition that requires anticoagulation therapy to prevent thromboembolic recurrence. Current guidelines recommend oral anticoagulation for a duration of 3 to 12 months following acute CVT. However, these recommendations are largely extrapolated from studies on extracerebral venous thrombosis, such as deep vein thrombosis (DVT), which may not be entirely applicable to CVT. The risk of thrombotic recurrence after CVT appears to be lower compared to extracerebral venous thrombosis. Most recurrences occur within the first year, but the absolute risk remains relatively low both in isolation and in comparison to DVT. While extended anticoagulation could potentially reduce the risk of recurrence, it also increases the likelihood of major bleeding complications. Given the uncertainty regarding the optimal duration of anticoagulation in CVT, this study aims to determine the most appropriate duration of oral anticoagulation following acute, symptomatic, and radiologically confirmed CVT
Null Hypothesis- Risk of venous thromboembolic event recurrence is similar in between 3 months and 6 months oral anticoagulation therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Male
入选标准
- •Patients with acute symptomatic and radiologically confirmed cerebral vein thrombosis (CVT).
- •CVT must have been diagnosed within 1 month before inclusion.
- •Written informed consent.
排除标准
- •General contraindications for anticoagulant therapy.
- •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.
- •Life expectancy less than 2 years due to a pre-existing condition (including any malignancy).
- •Known allergy to study medications.
- •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).
结局指标
主要结局
The Primary efficacy outcome will be composite of Venous Thromboembolic Events (DVT, PE and recurrent CVT) at 12 months.
时间窗: 12 months
次要结局
- Recanalization rate at 3 months and 6 months of anticoagulation therapy – as assessed by MRI Angiography.(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.(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.(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.(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 months)
- Functional outcome measured by Modified Rankin Scale (mRS-Score) at 3, 6 and 12(months.)
- Safety Outcome minor and major Haemorrhage -rate of haemorrhagic stroke, symptomatic intracerebral haemorrhage or other symptomatic intracranial and extracranial haemorrhage like upper GI bleed etc(3 month, 6 month, 12 month)
研究者
Mritunjai Kumar
AIIMS Rishikesh