Warfarin After Anterior ST-Elevation Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Combined death, MI, embolic event (TIA, stroke, non-cns emboli), Major Bleeding, and LVT (as determined by echocardiography) at 3 months
研究概览
简要总结
Following severe heart attacks involving the front wall of the heart (anterior myocardial infarction), patients are at risk of developing blood clots in the main pumping chamber that can cause a stroke. In the past, studies have shown that a blood thinner (warfarin) can decrease the risk of stroke and clot formation if administered to patients after an anterior myocardial infarction.
However, in today's current practice, certain heart attack patients are commonly treated with two blood-thinning medications (aspirin and clopidogrel) to prevent recurrent heart attacks.
Thus, a clinical problem is created as physicians are not clear how to treat patients after an anterior myocardial infarction who are at risk of a clot but require aspirin and clopidogrel to keep their blood vessels open. Adding warfarin to the combination of aspirin and clopidogrel will possibly decrease the risk of stroke but increase the risk of bleeding. Currently, there is no good evidence to help guide physicians. As demonstrated by a survey done at the Hamilton Health Sciences, there is a fifty/fifty split between physicians who use dual (aspirin and clopidogrel) versus triple (aspirin, clopidogrel, and warfarin) therapy in the treatment of similar patients as described above.
The purpose of this study is to address the bleeding and stroke complications in patients after a severe anterior myocardial infarction. Half of the eligible patients will receive dual therapy and half will receive triple therapy. We will compare the incidence of stroke, blood clots, and bleeding complications between the two groups at 3 months.
详细描述
Rationale:
Left ventricular mural thrombus (LVT) remains a common complication after anterior ST-elevation myocardial infarction (STEMI) with a reported incidence ranging from 12- 17%. Previous studies from the pre-thrombolytic era have shown that warfarin therapy significantly reduces the incidence of LVT and embolic events in patients post anterior STEMI. However, the risk/benefit ratio of warfarin therapy in the setting of early revascularization and dual antiplatelet therapy with aspirin and clopidogrel remains unknown.
Purpose:
To compare the incidence of death, MI, stroke, embolic events, LVT, and bleeding complications at 3 months in patients with an anterior STEMI and ejection fraction less than 40% treated with ASA and clopidogrel alone versus those treated with aspirin, clopidogrel, and warfarin (triple therapy group).
Sample Size:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Anterior STEMI
- •An ejection fraction less than 40% as per initial LV angiography or echocardiogram
- •Randomization possible within hospital admission if anticoagulated with no interruption > 24 hours
- •Patient able and willing to give informed consent to participate in this trial
排除标准
- •history of intracranial hemorrhage
- •history of GI bleed last 6 months
- •hemoglobin < 90 g/L
- •platelet count < 100 x 10exp9/L
- •ischemic stroke last 30 days
- •intracranial tumor or aneurysm
- •significant pericardial effusion
- •severe renal failure (creatinine > 250 mmol/L).
研究组 & 干预措施
1
aspirin and clopidogrel
干预措施: aspirin + clopidogrel (Drug)
2
aspirin, clopidogrel, and warfarin
干预措施: aspirin + clopidogrel + warfarin (Drug)
结局指标
主要结局
Combined death, MI, embolic event (TIA, stroke, non-cns emboli), Major Bleeding, and LVT (as determined by echocardiography) at 3 months
时间窗: 3 months
次要结局
- Individual endpoints of LVT at discharge and at 3 months (determined by echocardiography), death, MI, stroke, TIA, non-CNS emboli, and minor bleeding(3 months)