A Randomized Trial of Higher vs. Lower Dose Heparin for PCI
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 16,000
- 试验地点
- 1
- 主要终点
- Number of Participants with any of the following: death, myocardial infarction or target vessel revascularization
研究概览
简要总结
HD PCI is a multicenter, randomized, registry-based, cluster crossover design trial of higher dose versus lower dose heparin in patients undergoing elective percutaneous coronary intervention (PCI).
详细描述
The primary objective of HD PCI is to compare the effect of a policy of higher dose heparin (100 U/kg) use to a policy of lower dose heparin (70 U/kg) use on death, myocardial infarction (MI) or target vessel revascularization (TVR) in patients undergoing elective percutaneous coronary intervention (PCI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
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
- •Patients undergoing elective PCI
排除标准
- •Age <18 years
- •Planned chronic total occlusion PCI
- •Non-resident precluding follow up through local registries
- •Hospital (Cluster) Eligibility Criteria
- •Hospitals will be eligible to participate if they meet the following criteria:
- •Submit PCI procedure data to a compatible registry that is able to provide data for the trial
- •Site agrees to manage patients as per the higher or lower dose heparin policy in place during the given crossover period
研究组 & 干预措施
Higher Dose Unfractionated Heparin Treatment Period
A centre wide policy of administering 100 U/kg bolus of intravenous unfractionated heparin (UFH) for elective percutaneous coronary intervention (PCI) procedures will be implemented during the Higher Dose UFH treatment period.
干预措施: Higher Dose UFH (Drug)
Lower Dose Unfractionated Heparin Treatment Period
A centre wide policy of administering 70 U/kg bolus of intravenous UFH for elective PCI procedures will be implemented during the Lower Dose UFH treatment period.
干预措施: Lower Dose UFH (Drug)
结局指标
主要结局
Number of Participants with any of the following: death, myocardial infarction or target vessel revascularization
时间窗: up to 30 days after PCI
次要结局
- Number of Participants with major bleeding(up to 30 days after PCI)
- Number of Participants with any of the following: death, myocardial infarction, target vessel revascularization or major bleeding(up to 30 days after PCI)