NCT02448550终止3 期
Comparison of Unfractionated Heparin and Bivalirudin for Percutaneous Coronary Intervention for Stable Angina, Unstable Angina, and Non-ST Segment Elevation Myocardial Infarction
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Net adverse clinical events (composite of efficacy and safety [bleeding] endpoints)
研究概览
简要总结
The purpose of this trial is to determine whether bivalirudin is non-inferior to unfractionated heparin in patients with stable angina, unstable angina, or non-ST segment elevation myocardial infarction undergoing percutaneous coronary intervention.
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
- Single (Participant)
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
- •Undergoing PCI for stable angina, unstable angina, or non-ST segment elevation myocardial infarction.
- •Age 18 years or older.
排除标准
- •Inability to obtain consent
- •Emergency cardiac catheterization for ST-segment elevation myocardial infarction.
研究组 & 干预措施
bivalirudin
Experimental
Bivalirudin will be used for PCI with bailout glycoprotein 2b3a inhibitor use permitted.
干预措施: Bivalirudin (Drug)
unfractionated heparin
Active Comparator
Unfractionated heparin will be used for PCI with bailout glycoprotein 2b3a inhibitor use permitted.
干预措施: Unfractionated heparin (Drug)
结局指标
主要结局
Net adverse clinical events (composite of efficacy and safety [bleeding] endpoints)
时间窗: 30-days
次要结局
- all cause mortality, myocardial infarction, or unplanned revascularization for ischemia(30-days)
- Bleeding Academic Research Consortium grade III or V bleeding events(30-days)
研究者
研究点 (1)
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A study to compare two treatments to patients with STEMI or NSTEMI. The study will evaluate all cause death, myocardial infarction, stroke, stent trombosis and bleeding after treated with PCI - Percutaneous coronary interventioPatients with STEMI and NSTEMI treated with PCI and either Bivalirudin (optional to add up to 3000U heparin in lab or up to 5000U given prehospital ) compared to Heparin 70 - 100U/kg aloneMedDRA version: 17.1Level: LLTClassification code 10064347Term: Non ST segment elevation myocardial infarctionSystem Organ Class: 100000004849MedDRA version: 17.1Level: LLTClassification code 10064345Term: ST segment elevation myocardial infarctionSystem Organ Class: 100000004849EUCTR2012-005260-10-SEppsala Clinical Research Center6,000