Clopidogrel Reloading in Patients With Non-ST Elevation Acute Coronary Syndrome Undergoing PCI on Chronic Clopidogrel Therapy. Results of the ARMYDA RELOAD ACS (Antiplatelet Therapy for Reduction of MYocardial Damage During Angioplasty in Acute Coronary Syndrome) Randomized Trial.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Major Adverse Cardiovascular Events
研究概览
简要总结
Patients who developed an acute coronary syndrome despite dual antiplatelet therapy with aspirin and clopidogrel may benefit from a further dose of clopidogrel before a percutaneous coronary intervention.
The aim of this study is to evaluate safety and effectiveness of clopidogrel reloading in patients on chronic clopidogrel therapy with acute coronary syndrome undergoing percutaneous coronary intervention.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic (> 10 days) therapy with clopidogrel (75 mg/day)
- •non-ST-segment elevation acute coronary syndrome (ACS) requiring early diagnostic angiography
排除标准
- •primary percutaneous coronary intervention (PCI) for acute ST-segment elevation acute myocardial infarction
- •platelet count < 70 × 10^9/L
- •high bleeding risk
- •coronary bypass grafting in the previous 3 months
研究组 & 干预措施
Reload
600 mg of clopidogrel loading dose 6-8 h before coronary angiogram, in addition to the chronic daily dose of 75 mg
干预措施: Clopidogrel (Drug)
Placebo
Placebo arm in addition to the chronic daily dose of 75 mg
干预措施: Placebo (Drug)
结局指标
主要结局
Major Adverse Cardiovascular Events
时间窗: 30 days
Death Myocardial Infarction Target Vessel Revascularization
次要结局
- Bleeding Events(30 days)
- Grade of platelet residual reactivity(Immediately before PCI (4-6h after randomization), 8h and 24h after PCI)
研究者
Patti Giuseppe
MD, FACC, Co-Chair of the ARMYDA Study Group, Assistant Professor of Cardiology
Campus Bio-Medico University