NCT01777503已完成4 期
Phase IV: A Comparison of Reduced-dose Prasugrel and Clopidogrel in Elderly Patients With Acute Coronary Syndrome Undergoing Early Percutaneous Coronary Intervention (PCI)
Azienda USL Reggio Emilia - IRCCS2 个研究点 分布在 1 个国家目标入组 1,457 人开始时间: 2012年11月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,457
- 试验地点
- 2
- 主要终点
- The composite of all-cause mortality, myocardial infarction (MI), disabling stroke and re-hospitalization for cardiovascular causes or bleeding within one year
研究概览
简要总结
The objective of this study is to compare reduced-dose prasugrel and standard dose clopidogrel in patients older than 74 years with ACS, including non-ST-elevation (NSTEACS) and ST-elevation (STEMI) patients, undergoing early PCI. The primary endpoint of the trial will be the one-year composite of (all-cause)death, myocardial infarction, stroke and re-hospitalization due to cardiovascular reasons or 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients >74 years of age hospitalized for an ACS, with or without STE, with an onset of symptoms during the previous 72 hours, and candidates to an early PCI.
- •STEMI patients may be randomized upon first diagnosis, provided they do not meet any exclusion criteria. STEMI patients should not exceed 50 percent of the global population of the study
- •Eligible NSTEACS patients may be randomized after coronary angiography. To be eligible, NSTEACS patients must have at least one of the following characteristics:
- •elevated troponin levels;
- •diabetes mellitus;
- •prior MI;
- •at least one new ischemic episode while on standard treatment during the index hospitalization;
- •ACS due to stent thrombosis.
排除标准
- •History of stroke or transient ischemic attack (TIA)
- •Gastrointestinal or genitourinary bleeding of clinical significance within 6 weeks prior to randomization.
- •Hemoglobin level on admission <10 g/dl, unless this is considered to be secondary to renal dysfunction or known myelodysplasia.
- •Secondary causes of acute myocardial ischemia.
- •Known current platelet count < 90,000 cells/mL.
- •Ongoing oral anticoagulant treatment or an INR known to be >1.5 at the time of screening.
- •Concomitant severe obstructive lung disease, malignancy or neurologic deficit limiting follow-up or adherence to the study protocol.
- •Participation in any phase of another clinical research study involving the evaluation of another investigational drug or device within 30 days prior to randomization
- •Inability to give at least verbal informed consent to the study.
- •Contraindications to the use of clopidogrel or prasugrel as per package leaflet.
研究组 & 干预措施
prasugrel
Experimental
prasugrel 60 mg loading dose, followed by 5 mg once daily until the end of follow-up
干预措施: prasugrel (Drug)
clopidogrel
Active Comparator
Clopidogrel 300 mg loading dose followed by 75 mg once day until the end of follow-up
干预措施: Clopidogrel (Drug)
结局指标
主要结局
The composite of all-cause mortality, myocardial infarction (MI), disabling stroke and re-hospitalization for cardiovascular causes or bleeding within one year
时间窗: 1 year
次要结局
- The composite of burden of recurrent cardiovascular (CV) events, CV mortality, all-cause mortality and MI, major bleeding, any stroke, total number of days spent in hospital.(1 year)
研究者
研究点 (2)
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