Clopidogrel 600 mg and 300 mg as a Loading Dose Prior to Percutaneous Coronary Intervention And Serum Troponin Level Elevation: A Pilot Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 155
- 试验地点
- 1
- 主要终点
- Incidence of post-percutaneous coronary intervention elevation of troponin T.
研究概览
简要总结
Primary Objective: To test if 600 mg of clopidogrel loading dose administered ≥ 6 and ≤ 24 hours prior to PCI produce a greater decrease of periprocedural release of biochemical markers (CK, CK-MB, and troponin-T and/or I) of myocardial necrosis, compared to 300 mg loading dose, given ≥ 6 and ≤ 24 hours prior to PCI or 600 mg loading dose of clopidogrel, administered immediately (≤ 45 minutes) before PCI.
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
- •Patients having symptomatic coronary artery disease with objective evidence of ischemia (eg, symptoms of angina pectoris, positive stress test results or dynamic electrocardiographic (ECG) changes).
- •Patients undergoing stent implantation
排除标准
- •Any known contraindication to the use of aspirin or clopidogrel.
- •Patients receiving clopidogrel within 10 days, thrombolytics within 24 hours or receiving oral anticoagulation therapy
- •Elective administration of IIb/IIIa inhibitors.
- •Cardiogenic shock
- •Acute MI< 24 hours
- •BP systolic <100 mmHg
- •Left ventricular ejection fraction < 30%
- •Heart failure, NYHA class III or IV
- •Severe renal insufficiency (creatinine > 3.0 mg/dL)
- •Platelet count <100,000/mm³
- •Target lesion in a venous bypass graft
- •Target lesion in a chronic occlusion
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
300-mg loading dose of clopidogrel given ≥ 6 and ≤ 24 hours before PCI
干预措施: Clopidogrel (Drug)
2
600-mg loading dose of clopidogrel given ≥ 6 hours and ≤ 24 before PCI.
干预措施: Clopidogrel (Drug)
3
600-mg loading dose of clopidogrel given immediately (≤ 45 minutes) before PCI.
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Incidence of post-percutaneous coronary intervention elevation of troponin T.
时间窗: At 6 and 12 months post-PCI
次要结局
- Adverse events.(From the beginning to the end of the study)
- Standard hematology and blood chemistry.(At 6 and 12 months post-PCI)