EUCTR2019-003244-79-ES进行中（未招募）1 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
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Bayer AG
- 入组人数
- 1,600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 800
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 800
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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