A RandomisED StUdy Comparing Standard Systemic Anticoagulation ThErapy to Low Dose Intracoronary Anticoagulation Therapy for Elective Percutaneous Coronary Intervention
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Major Adverse Cardiac Events
研究概览
简要总结
The hypothesis:
Low dose intracoronary unfractionated heparin is as effective and safe as standard dose intravenous unfractionated heparin on patients with elective percutaneous coronary intervention.
详细描述
Aim:
Primary objective:To evaluate the efficiency and safety of low dose intracoronary unfractioned heparin (UFH) on elective percutaneous coronary intervention (PCI).
Secondary objective:
- To evaluate the effect of low dose intracoronary UFH on myocardial ischemia after PCI.
- To evaluate the effect of low dose intracoronary UFH on bleeding complications after PCI.
- To evaluate the cost-effectivity of low dose intracoronary UFH on elective PCI
Study central:
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients; who have planned elective PCI and have had written informed consent for participation to study.
- •The native coronary artery;
- •lesion with narrowing >=70%,
- •lesion without thrombus
- •no left main coronary artery (LMCA) lesion
- •no chronic total occlusion lesion
排除标准
- •Patients have allergy for acetylsalicylic acid (ASA), Clopidogrel and heparin
- •Patients who performed primary PCI
- •Patients with acute coronary syndrome
- •Patients with have a history of myocardial infarction (MI) for two weeks
- •Patients who were use UFH or low molecular weight heparin (LMWH) for 24 hours
- •Patients on warfarin therapy
- •Patients who have bleeding diathesis, or have high risk for bleeding.
研究组 & 干预措施
Low dose intracoronary heparin
Low dose intracoronary heparin: In this group elective coronary intervention was performed with low dose intracoronary Heparin
干预措施: coronary intervention (Other)
Standard treatment arm
Standard treatment arm: In this group elective coronary intervention performed with standard dose intravenous heparin
干预措施: coronary intervention (Other)
结局指标
主要结局
Major Adverse Cardiac Events
时间窗: 30 days
Major Adverse Cardiac Event
时间窗: 30 days
次要结局
未报告次要终点
研究者
Hasan ARI
Bursa Postgraduate Hospital
Bursa Postgraduate Hospital