NCT00669149终止4 期
Anticoagulant Treatments Evaluation During Percutaneous Coronary Angioplasty in Stable Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- ischaemic events via troponin Ic measurements during 24 hours post procedure
研究概览
简要总结
The purpose of this study is to determine whether adjunction of intravenous anticoagulant therapy (enoxaparin, HNF, bivalirudin) to antiaggregation with clopidogrel and aspirin improves in-hospital results of percutaneous transluminal coronary angioplasty (ptca) in selected patients.
详细描述
- Background : We don't know if using IV anticoagulant therapy is necessary for percutaneous coronary angioplasty in stable patients.
- Purpose : to compare efficacy and security of use or not of different anticoagulant treatments during percutaneous coronary angioplasty in patients with double antiaggregant therapy.
- Abstract : In stable patients pretreated with double antiaggregant therapy use of IV anticoagulants has not been yet evaluated during angioplasty. In this prospective randomized trial we want to compare in such patients the efficacy and security of the administration of IV heparin, IV enoxaparin, IV bivalirudin and no use of anticoagulant during coronary angioplasty. We will evaluate in each group ischaemic events (clinic, ECG and biology) and haemorrhagic events (clinic, biology) with a one month follow up.
- Primary outcome: ischaemic events via troponin Ic measurements during 24 hours post procedure.
- Secondary outcomes: haemorrhagic events : clinical and biological evaluation (Hb, Ht, TIMI score)
- Study design : monocentric randomized clinical trial type therapeutic equivalence phase IV.
- Interventions : In patients prepared with therapeutic association (aspirin clopidogrel) comparison between use or no of anticoagulant (IV heparin, IV enoxaparin or IV bivalirudin).
- Number of subjects : 120 per group (total of 480).
- Statistical analysis : multivariate analysis with logistic regression models : each end point (troponin Ic increase, haemoglobin decrease, ...) will be explicated with treatment group and other covariates (sex, age, creatinine, ...).
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
- 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
- •stable angina pectoris or silent ischaemia
排除标准
- •instable angina or ACS (Acute Coronary Syndrome)
研究组 & 干预措施
1
Experimental
group without anticoagulant therapy
干预措施: clopidogrel + aspirin (Drug)
2
Active Comparator
group with heparin
干预措施: heparin + clopidogrel + aspirin (Drug)
3
Active Comparator
group with enoxaparin
干预措施: enoxaparin + clopidogrel + aspirin (Drug)
4
Active Comparator
group with bivalirudin
干预措施: bivalirudin + clopidogrel + aspirin (Drug)
结局指标
主要结局
ischaemic events via troponin Ic measurements during 24 hours post procedure
时间窗: 24 hours
次要结局
- haemorrhagic events : clinical and biological evaluation(24 hours)
研究者
研究点 (1)
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