A Multi-center Study on the Optimized Antithrombotic Therapy of Acute Myocardial Infarction With Left Ventricular Mural Thrombus.
试验速览
- 阶段
- 4 期
- 入组人数
- 120
- 主要终点
- Left ventricular mural thrombus-1
研究概览
简要总结
A multi-center study will be done to explore the optimal regimen of antithrombotic therapy for acute myocardial infarction with left ventricular mural thrombus. The investigators will evaluate the different combinations of antiplatelet drugs and anticoagulants for at least one month, such as aspirin 100mg qd+clopidogrel 75mg qd+warfarin (INR1.8-2.2), aspirin 100mg qd+clopidogrel 75mg qd+dabigatran 110mg bid, aspirin 100mg qd+ticagrelor 60mg bid+warfarin (INR1.8-2.2), and aspirin 100mg qd+ticagrelor 60mg bid+dabigatran 110mg bid. Transthoracic two-dimensional echocardiography will be done at the 1-month, 3-month and 6-month follow-ups to evaluate the left ventricular mural thrombus and determinate whether the antithrombotic therapy regimen could be regulated to double antiplatelet or anticoagulant+clopidogrel 75mg qd/ticagrelor 60mg bid. Then the investigators will complete the 12-month follow-up to evaluate the efficacy and safety of the optimal antithrombotic therapy regimen for acute myocardial infarction with left ventricular mural thrombus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute myocardial infarction with left ventricular mural thrombus
排除标准
- •BARC bleedings ≥ 2
- •atrial fibrillation
- •acute stroke or other systemic circulation embolism
研究组 & 干预措施
aspirin100mg qd+clopidogrel75mg qd+warfarin (INR1.8-2.2)
干预措施: Combination of antiplatelet drugs and anticoagulants for at least one month (Drug)
aspirin100mg qd+clopidogrel75mg qd+dabigatran110mg bid
干预措施: Combination of antiplatelet drugs and anticoagulants for at least one month (Drug)
aspirin100mg qd+ticagrelor60mg bid+warfarin(INR1.8-2.2)
干预措施: Combination of antiplatelet drugs and anticoagulants for at least one month (Drug)
aspirin100mg qd+ticagrelor60mg bid+dabigatran110mg bid
干预措施: Combination of antiplatelet drugs and anticoagulants for at least one month (Drug)
结局指标
主要结局
Left ventricular mural thrombus-1
时间窗: 1-month
Number of Participants Without left ventricular mural thrombus as Assessed by echocardiograph at 1-month.
Left ventricular mural thrombus-3
时间窗: 3-month
Number of Participants Without left ventricular mural thrombus as Assessed by echocardiograph at 3-month.
Left ventricular mural thrombus-6
时间窗: 6-month
Number of Participants Without left ventricular mural thrombus as Assessed by echocardiograph at 6-month.
次要结局
- Target vessel revascularization(12 months)
- Major cardio-cerebral vascular events(12 months)
- Recurrent myocardial infarction(12 months)
- Stent restenosis(12 months)
- Death(12 months)
- Stroke or other systemic circulation embolism(12 months)