NCT01031095已完成3 期
A RandomisED StUdy Comparing Standard Systemic Anticoagulation ThErapy to Low Dose Intracoronary Anticoagulation Therapy for Elective Percutaneous Coronary Intervention
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Major Adverse Cardiac Event
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.
结局指标
主要结局
Major Adverse Cardiac Event
时间窗: 30 days
Major Adverse Cardiac Events
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
研究点 (2)
Loading locations...
相似试验
终止
不适用
Propaten Randomized Investigation on Cost-benefit and EfficacyEnd-stage Renal DiseaseNCT01601873The University of Texas Health Science Center, Houston103
已完成
2 期
Heparin and deep vein thrombosisDeep vein throbmosis.Formation of thrombosis in the deep veinsIRCT201402113449N14Vice Chancellor for Research, Tehran University of Medical Sciences46
Unknown
不适用
When Heparin Stopped for Anticoagulation During ECMO DecannulationExtracorporeal Membrane OxygenationNCT05239637Second Affiliated Hospital of Zhengzhou University40
已完成
4 期
Long-Term Low-Molecular-Weight Heparin Versus Oral Anticoagulants in Deep Venous ThrombosisVenous ThromboembolismNCT00689520Hospital Universitari de Bellvitge241
已完成
不适用
Evaluating Dose Regimen of Intravenous Unfractionated Heparin and Low Molecular Weight Heparin in Critical Ill Patients Versus Critical Ill COVID-19 Patients Using Anti-Xa Levels.COVID-19Deep Vein ThrombosisAnticoagulants and Bleeding DisordersCritical IllnessNCT05224388University Hospital, Ghent813