Efficacy and Safety of Low Dose Rivaroxaban in Patients With Anterior Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Major adverse cardiovascular event
研究概览
简要总结
Despite the use of guideline directed optimal medical therapy, 12% of patients with stable coronary heart disease and 18% of patients with recent acute coronary syndrome experience recurrent major adverse cardiovascular events 1. The risk of recurrent cardiovascular events may be related to persistent elevation of thrombin beyond the index event 2,3
which leads to progression of cardiovascular disease by inducing inflammation, endothelial dysfunction and thrombosis 4. In patients with coronary heart disease, vitamin K antagonists (VKAs) and direct oral anticoagulants (DOACs) have been explored as secondary prevention strategies and have shown cardiovascular benefits at the cost of higher bleeding events 5,6,7,8.
howeverLeft ventricular thrombus (LVT) usually appearswithin 1 month after ST-segment elevation myocardial infarction (STEMI) and mostlyforms after anterior STEMI.9,11Although the prevalenceof LVT after acute myocardial infarction hasdecreased dramatically in modern times due to the progress of reperfusion therapy, LVT incidence in patients with anterior STEMI remains at 4% to 26%.10,12 It complicates acute myocardial infarction and is associated with a higher incidence of poor outcomes.9
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •patients with anterior ST-segment myocardial infarction on acetylsalicylic acid and clopidogrel
排除标准
- •Patients with liver cirrhosis.
- •Patients with severe mitral stenosis .
- •Patients with bleeding tendency (HASBLED score ≥ 3)
- •Severe renal impairment ( creatinine clearance < 30 ml/min ).
- •patients with prosthetic valve .
- •patients on ticagrelor treatment
- •patients with Atrial Fibrillation
研究组 & 干预措施
-group of patients(75 patients) will receive low dose rivaroxaban
-group of patients(75 patients) will receive low dose rivaroxaban (rivaroxaban 2.5 mg twice daily orally) for 1 month after anterior ST-segment myocardial infarction plus dual antiplatelet therapy (acetylsalicylic acid 75 mg once daily orally and cloppe
干预措施: -group of patients(75 patients) will receive low dose rivaroxaban myocardial infarction plus (acetylsalicylic acid 75 mg and clopidogrel 75 mg (Drug)
control group of patients:
control group of patients: 75 Patients of anterior ST-segment myocardial infarction on dual antiplatelet therapy only
干预措施: (acetylsalicylic acid 75 mg once daily orally and clopidogrel 75 mg once daily orally only) (Drug)
结局指标
主要结局
Major adverse cardiovascular event
时间窗: 10 months
Major adverse cardiovascular event
Left ventricular thrombus
时间窗: 10 months
Left ventricular thrombus
Transient Ischemic Attacks or cerebrovascular stroke
时间窗: 10 months
Transient Ischemic Attacks or cerebrovascular stroke
Left ventricular function
时间窗: 10 months
Left ventricular function
次要结局
未报告次要终点
研究者
Mohamed Elamir Saber
resident doctor at internal medecine department
Sohag University