NL-OMON54974已完成2 期
Multicenter, randomized, placebo controlled, double-blind, parallel group, dose-finding Phase 2 study to evaluate the efficacy and safety of BAY 2433334 in patients following an acute myocardial infarction - PACIFIC-AMI
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 196
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Participants must be 45 years of age or older, at the time of signing the
- •informed consent
- •2. Acute myocardial infarction (excluding MI associated with PCI or CABG
- •revascularization procedures) with:
- •a.clinical symptoms of acute myocardial infarction AND
- •b.elevated biomarkers of myocardial necrosis (creatine kinase-muscle and brain
- •isoenzyme [CK-MB] or cardiac troponins) AND
- •c.at least one of the following risk factors need to be fulfilled:
- •i. Age * 65 years
- •ii.Prior MI (before the index AMI event)
- •iii.Prior peripheral arterial disease
- •iv.Diabetes Mellitus
- •v.Prior coronary artery bypass grafting (CABG)
- •d. initial angiography and revascularization procedures, either PCI or CABG,
- •as treatment for the index event performed before randomization. (Note: a
- •planned, staged PCI procedure can be performed after randomization)
- •3. Plan for dual antiplatelet therapy (ASA + P2Y12 inhibitor) after hospital
- •discharge for the index AMI
- •4. Randomization during hospitalization for the index AMI event and latest
- •within 5 days of hospital admission
- •5. Capable of giving signed informed consent which includes compliance with the
- •requirements and restrictions listed in the informed consent form (ICF) and in
- •this protocol. Written informed consent has to be signed before any
- •study-specific procedure.
排除标准
- •1. Hemodynamically significant ventricular arrhythmias or cardiogenic shock at
- •time of randomization
- •2. Active bleeding; known bleeding disorder, history of major bleeding
- •(intracranial, retroperitoneal, intraocular) or clinically significant
- •gastrointestinal bleeding within last 6 months of randomization
- •3. Planned use or requirement of full dose and long term anticoagulation
- •therapy during study conduct
研究者
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