NCT04221919尚未招募不适用
Different β -Blockers in Patients With ST-segment Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,200
- 主要终点
- Change in LVEDV from baseline
研究概览
简要总结
Carvedilol, target dose: 50 mg daily; Bisoprolol, target dose: 10 mg daily; Metoprolol tartrate, target dose: 150 mg daily; Metroprolol succinate, target dose: 200 mg daily
详细描述
The investigators will investigate the efficacy and safety of different β -blockers, as well as heart rate variability, in STEMI patients undergoing primary PCI.
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
- Triple (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
- •Admitted for primary PCI for STEMI involving the LAD within 12 hours of onset of symptoms. STEMI will be defined as typical ECG changes (ST segment elevation ≥2mm in 2 or more precordial leads) associated with acute chest pain or an elevation of cardiac enzymes;
- •Age ≥18 years;
- •Informed consent from patient or next of kin.
排除标准
- •Nonischaemic Cardiomyopathy;
- •Cardiac surgery planed in the 6 months;
- •Mechanical complication of STEMI (ventricular septal rupture, free wall rupture, acute severe mitral regurgitation);
- •Renal or hepatic failure;
- •Malignancy, HIV, or central nervous system disorder;
- •Cardiopulmonary resuscitation >15 min and compromised level of consciousness;
- •Cardiogenic shock;
- •Current participation in any research study involving investigational drugs or devices;
- •No written consensus;
- •Previous myocardial infarction.
研究组 & 干预措施
Carvedilol
Experimental
干预措施: β -Blockers (Drug)
Bisoprolol
Experimental
干预措施: β -Blockers (Drug)
Metoprolol tartrate
Experimental
干预措施: β -Blockers (Drug)
Metoprolol succinate
Experimental
干预措施: β -Blockers (Drug)
结局指标
主要结局
Change in LVEDV from baseline
时间窗: 1 to 5 years
The primary outcome of this study will be the change from baseline in left ventricular end diastolic volume (LVEDV) post-PCI.
Major adverse cardiovascular events (MACE)
时间窗: 1 to 5 years
次要结局
未报告次要终点
研究者
Pan-Pan Hao
MD
Qilu Hospital of Shandong University
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