NCT00136929Unknown不适用
A Prospective Randomized Trial of Primary Angioplasty Versus Thrombolytic Therapy for Acute Myocardial Infarction in the Elderly "Senior PAMI"
PAMI Coordinating Center0 个研究点目标入组 530 人开始时间: 2005年8月29日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 530
研究概览
简要总结
This is a prospective, randomized, multi-center, international trial comparing two reperfusion strategies in elderly (age >= 70 years) patients with acute myocardial infarction: primary percutaneous coronary intervention (PCI) versus intravenous thrombolytic therapy. Clinical endpoints will be collected in the hospital, at 1 month, 6 months, and 1 year post-randomization. The primary endpoint is 30 day death or disabling stroke. The study null hypothesis is that there will be no significant difference in death or disabling stroke at 30 days post-randomization between patients treated with PCI versus thrombolytics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age >= 70
- •Clinical symptoms > 30 minutes
- •Symptom onset <= 12 hours
- •ST segment elevation >= 1 mm in 2 or more leads
排除标准
- •Prior thrombolytics
- •Cardiogenic shock
- •Cerebrovascular accident (CVA)
- •Prolonged cardiopulmonary resuscitation (CPR)
- •Blood pressure (BP) > 180/100 mm Hg
- •Active bleeding
- •International Normalized Ratio (INR) > 1.4
- •Acetylsalicylic acid [aspirin] (ASA) or heparin allergy
- •History of neutropenia, thrombocytopenia, hepatic dysfunction, or renal insufficiency
- •Peripheral vascular disease (PVD)
研究者
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