A Prospective, Multicenter, Randomized, Open-label Trial to Evaluate Efficacy and Safety of 5mg Maintenance Dose of Prasugrel in Patients With Acute Coronary Syndrome Who Underwent Percutaneous Coronary Intervention With BiomatrixTM Stent
试验速览
- 阶段
- 4 期
- 入组人数
- 1,400
- 试验地点
- 1
- 主要终点
- A compoiste of cardiac death, non-fatal myocardiac infarction and stroke
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of 5mg maintenance dose (MD) of prasugrel in patients with acute myocardial infarction (AMI) who underwent percutaneous coronary intervention (PCI) with BiomatrixTM stent.
详细描述
About 1400 patients derived from Korean patients with acute coronary syndrome (ACS) receiving percutaneous coronary intervention (PCI) with BES(Biolimus-eluting stent, BiomatrixTM) in a routine manner will be enrolled in the investigators trial.
These patients will be randomized 1:1 to either prasugrel 5mg once daily MD or clopidogrel 75mg once daily MD after successful PCI with BES .
The investigators excluded the patients with age ≥75 years, body weight <60 kg, or history of TIA (transient ischemic attack) or stroke. Follow-up data will be collected until 1-year after index procedure.
Primary efficacy end-point defined as the composite of cardiac death, non-fatal MI, stent thrombosis and ischemic driven target vessel revascularization and safety end-points as BARC (the Bleeding Academic Research Consortium) type ≥ 2 bleeding.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who can undergo percutaneous coronary intervention with Biomatrix stent with no history of TIA or stroke,
- •75 years old or younger,
- •body weight of 60 kg or more and diagnosed with acute coronary syndrome
排除标准
- •Patients with history of TIA or stroke,
- •75 years old or older,
- •body weight of 60 kg or under,
- •hypersensitivity to or contraindicated for heparin, aspirin, clopidogrel, prasugrel or contrast media
研究组 & 干预措施
BES with Prasugel 5mg
Biolimus-eluting stent with Prasugrel 5mg once daily MD
干预措施: BES (biodegradable polymer biolimus-eluting stent) (Device)
BES with Prasugel 5mg
Biolimus-eluting stent with Prasugrel 5mg once daily MD
干预措施: Prasugel (Drug)
BES with Clopidogrel 75mg
Biolimus-eluting stent with Clopidogrel 75mg once daily MD
干预措施: BES (biodegradable polymer biolimus-eluting stent) (Device)
BES with Clopidogrel 75mg
Biolimus-eluting stent with Clopidogrel 75mg once daily MD
干预措施: Clopidogrel (Drug)
结局指标
主要结局
A compoiste of cardiac death, non-fatal myocardiac infarction and stroke
时间窗: within the 1 year after BIOMATRIXTM Stent implantation
次要结局
- stent thrombosis(within the 1 year after BIOMATRIXTM Stent implantation)
- All-cause death(within the 1 year after BIOMATRIXTM Stent implantation)
- Target lesion revascularization(within the 1 year after BIOMATRIXTM Stent implantation)
- BARC bleeding 2,3,and 5(within the 1 year after BIOMATRIXTM Stent implantation)
- Cardiac death(within the 1 year after BIOMATRIXTM Stent implantation)
- non-fatal myocardial infarction(within the 1 year after BIOMATRIXTM Stent implantation)
- Stroke(within the 1 year after BIOMATRIXTM Stent implantation)
研究者
Myung Ho Jeong
MD, PhD
Chonnam National University Hospital