Apixaban Prophylaxis for Prevention of Left Ventricular Thrombus Following Anterior Myocardial Infarction: An Open Label, Randomized Clinical Trial (POTAMI)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 472
- 试验地点
- 1
- 主要终点
- Incidence of LV thrombus formation in the treatment arm vs. control group
研究概览
简要总结
The objective of this randomized controlled trial is to compare the safety and efficacy of low dose Apixaban (2.5 mg bid) in addition to guideline directed medical therapy vs guideline directed medical therapy alone in the prevention of left ventricular thrombus formation (after 30-days) following primary PCI in patients with acute anterior myocardial infarction with severe LV dysfunction.
详细描述
Objective To compare the safety and efficacy of Apixaban vs. placebo in the prevention of LV thrombus formation in patients with acute anterior myocardial and severe LV dysfunction following primary PCI in an open label, randomized controlled trial.
Methods:
Inclusion Criteria .Patients aged 18-65 years, presenting with acute anterior STEMI and severe LV dysfunction (EF<35%) with antero-apical akinesis, dyskinesis, or aneurysm.
Exclusion Criteria
- Patients with previous myocardial infarction or revascularization procedures.
- Patients with cardiogenic shock
- Patients with advanced CKD (Cr < 2 and those on hemodialysis)
- Recent ICH or major bleed requiring transfusion, low platelet counts<100,000
- History of CVA
- Patients with atrial fibrillation or other indications for chronic anticoagulation
- Pregnant patients and those with hematological disorders
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-65 years
- •Presenting with acute anterior STEMI
- •Severe LV dysfunction (EF<35%) with antero-apical akinesis, dyskinesis, or aneurysm
- •WIHTOUT evidence of LV thrombus.
排除标准
- •Patients with previous anterior myocardial infarction or LAD revascularization procedures
- •Patients with cardiogenic shock
- •Patients with LV thrombus
- •Patients with advanced CKD (Cr > 2 and those on hemodialysis)
- •Recent ICH or major bleed requiring transfusion, low platelet counts <100,000
- •History of recent CVA ( within past three months)
- •Patients with atrial fibrillation or other indications for chronic anticoagulation
- •Pregnant patients and those with hematological disorders
研究组 & 干预措施
Study arm (Apixaban 2.5 mg bid)
Patients randomized to the treatment arm will be given Apixaban 2.5 mg twice daily and DAPT (aspirin (75 mg) + clopidogrel (75 mg)) for four weeks in addition to other guideline directed medical therapy (GDMT). After 4 weeks, treatment group will be switched to DAPT. o In the event of stent thrombosis during the study period, considering the high ischemic risk, the patient will be switched to ticagrelor instead of clopidogrel, and aspirin will be discontinued while Apixaban will be continued. After four weeks, the patient will be switched to DAPT (aspirin
- ticagrelor).
干预措施: Apixaban 2.5 MG PO BID (Drug)
Control group
The control arm will be of standard care i.e. DAPT in addition to other guideline directed medical therapy (GDMT).
干预措施: Control (Standard treatment) (Drug)
结局指标
主要结局
Incidence of LV thrombus formation in the treatment arm vs. control group
时间窗: one month
Incidence of LV thrombus formation in the treatment arm vs. control group at 4 week follow up echocardiography. This constitutes the primary endpoint of the trial
次要结局
- Secondary Outcomes(one month)
研究者
Professor Abdul Hakeem
professor
National Institute of Cardiovascular Diseases, Pakistan