A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects With Unstable Angina/Non-ST-Elevation Myocardial Infarction Who Are Medically Managed
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 9,326
- 试验地点
- 1
- 主要终点
- Percentage of Participants With a Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke
研究概览
简要总结
This study will evaluate the relative efficacy and safety of prasugrel and clopidogrel in a medically managed Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) acute coronary syndrome (ACS) population (that is, patients who are not managed with acute coronary revascularization).
详细描述
Based upon the significant number of subjects with UA/NSTEMI ACS who are managed medically and their high risk for future cardiovascular events, further exploration of novel treatment strategies for this population, who are under-represented in large clinical trials, is warranted. Potential subjects will be those with a recent UA/NSTEMI event who are to be medically managed. Eligibility for this study will be determined by both the timing of the medical management decision and by prior commercial clopidogrel treatment at the time of randomization. The TaRgeted platelet Inhibition to cLarify the Optimal strateGy to medicallY manage Acute Coronary Syndromes (TRILOGY ACS) Study will assess the efficacy and safety of prasugrel and aspirin compared to the current standard of care, clopidogrel and aspirin, for long-term treatment of medically managed UA/NSTEMI ACS subjects.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have had a Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) index event within 10 days prior to randomization
- •Had a medical management strategy decision made with reasonable certainty that neither percutaneous coronary intervention (PCI) nor coronary artery bypass graft (CABG) is planned for treatment of the index event
- •Had at least 1 of 4 specified high-risk features at the time of the UA/NSTEMI event
排除标准
- •Decision for medical management greater than 72 hours after onset of index event without commercial clopidogrel treatment within 72 hours following onset of the index event.
- •Insignificant coronary artery disease (CAD) on coronary angiography if performed for Index Event (absence of greater than or equal to 30% stenosis in at least one native vessel)
- •Previous or planned PCI or CABG as treatment for the index event
- •PCI/CABG within previous 30 days
- •ST-segment elevation myocardial infarction (STEMI) as the index event
- •Cardiogenic shock, Refractory ventricular arrhythmias, New York Heart Association (NYHA) Class IV congestive heart failure (CHF) within the previous 24 hours
- •History of ischemic or hemorrhagic stroke, transient ischemic attack (TIA), Intracranial neoplasm, arteriovenous malformation, or aneurysm
- •History of spontaneous gastrointestinal (GI) or non-GI bleeding requiring hospitalization for treatment, unless definitive treatment has occurred and there is low likelihood of recurrence
- •Hemodialysis or peritoneal dialysis
研究组 & 干预措施
Prasugrel
Prasugrel and Low-dose Commercially-available Aspirin
干预措施: Prasugrel (Drug)
Prasugrel
Prasugrel and Low-dose Commercially-available Aspirin
干预措施: Commercially-available Aspirin (Drug)
Clopidogrel
Clopidogrel and Low-Dose Commercially-available Aspirin
干预措施: Clopidogrel (Drug)
Clopidogrel
Clopidogrel and Low-Dose Commercially-available Aspirin
干预措施: Commercially-available Aspirin (Drug)
结局指标
主要结局
Percentage of Participants With a Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke
时间窗: Randomization through end of study (30-month visit)
The percentage of participants is the total number of participants experiencing a CV death, nonfatal MI, or nonfatal stroke divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
次要结局
- Percentage of Participants With a Composite Endpoint of CV Death and MI(Randomization through end of study (30-month visit))
- Percentage of Participants With a Composite Endpoint of All-cause Death, MI, or Stroke(Randomization through end of study (30-month visit))
- Biomarker Measurements of Inflammation/Hemodynamic Stress: Brain Natriuretic Peptide (BNP)(Day 30 and 6 Months)
- Economic and Quality of Life Outcomes(Baseline and follow-up (24 months))
- Summary of All Deaths(Randomization through end of study (30-month visit))
- Percentage of Participants With a Composite Endpoint of CV Death, MI, Stroke, or Re-hospitalization for Recurrent Unstable Angina (UA)(Randomization through end of study (30-month visit))
- Platelet Aggregation Measures(Day 30 and 12 Months)
- Biomarker Measurements of Inflammation/Hemodynamic Stress: C-Reactive Protein (CRP)(Day 30 and Month 6)
- Genotyping Related to Drug Metabolism(Baseline)