NCT05208398已完成3 期
Apixaban in Patients With Left Ventricular Thrombus Post Myocardial Infarction; A Randomized Clinical Trial
Saud Al Babtain Cardiac Center1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年2月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Resolution of left ventricular thrombus
研究概览
简要总结
Open label randomized controlled clinical trial to evaluate the efficacy and safety of apixaban versus warfarin in treating left ventricular thrombus in patients with acute or recent myocardial infarction (MI).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All the following criteria must be fulfilled:
- •Ages between 18 and 80 years,
- •History of anterior wall MI, either acute (within a week) or recent (within a month)
- •Evident left ventricular thrombus (LVT) by transthoracic echocardiography,
- •Naïve to oral anticoagulants (OAC)
- •stable to start OAC
排除标准
- •Other indications for OAC,
- •Patients with contraindications for OAC,
- •Right ventricular thrombus or atrial thrombus,
- •History of confirmed stroke or other systemic embolization within the previous six months,
- •High bleeding risk,
- •Severe renal impairment,
- •Patients with expected difficulties to follow the INR strictly.
研究组 & 干预措施
Apixaban
Experimental
Apixaban, 5 mg oral tablets, on top of updated guidelines of acute coronary syndrome management recommendations
干预措施: Apixaban (Drug)
Warfarin
Active Comparator
Warfarin, oral tablets, to achieve international normalized ratio (INR) of 2-3, on top of standards of care, as per updated guidelines of acute coronary syndrome management recommendations
干预措施: Warfarin (Drug)
结局指标
主要结局
Resolution of left ventricular thrombus
时间窗: 3 months
Transthoracic, noncontrast, echocardiographic assessment.
次要结局
- Resolution of left ventricular thrombus(6 months)
- Safety outcome(3-6 months)
研究者
研究点 (1)
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