Effect of the Repeated Loading Dose of Clopidogrel and High Dose of Clopidogrel Continuous Therapy on the Platelet Aggregation Inhibition in Patients With Myocardial Infarction Undergoing Interventional Treatment.
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- inhibition of platelet aggregation
研究概览
简要总结
REL-0609 trial's hypothesis is that repeated loading doses of clopidogrel (600 mg) administration in addition to high dose of clopidogrel continuous therapy (150 mg/day) results in higher inhibition of the platelets' aggregation in patients with myocardial infarction undergoing interventional treatment comparing to the standard therapy. Such treatment strategy will not cause increased risk of bleeding complications. In many trials treatment with to repeated loading doses of clopidogrel together with high dose of clopidogrel continuous therapy resulted in: MACE reduction, improvement of the long term therapy results, lower risk of ischemic complications. Currently, data regarding to the results of the above treatment are still limited.
详细描述
The objectives of the study is:
- to evaluate the effect of the repeated loading dose of clopidogrel (600 mg) in addition to high dose of clopidogrel continuous therapy (150 mg/day) on the platelet aggregation inhibition in patients with myocardial infarction undergoing interventional treatment
- to evaluate the safety of the repeated loading dose of clopidogrel (600 mg) in addition to high dose of clopidogrel continuous therapy (150 mg/day) in patients with myocardial infarction undergoing interventional treatment
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
- •≥18 years of age,
- •Myocardial Infarction with or without ST segment elevation,
- •clopidogrel treatment (confirmed administration of loading dose of 600 mg or chronic therapy of 75 mg/day),
- •signed written informed consent.
排除标准
- •prior administration of fibrinolytic therapy and/or GP IIb/IIIa inhibitors within the last 14 days,
- •prior administration of prasugrel within the last 14 days,
- •subject with known hypersensitivity to the active ingredient or other components of the product
- •increased risk of bleeding complications:bleeding diathesis, thrombocytopenia (platelet count < 100 000/mm3), oral anticoagulant therapy (INR >1.6), uncontrolled hypertension (systolic blood pressure >200 mmHg), major bleeding, trauma or surgery within the last 30 days,
- •acute renal failure,
- •acute liver failure,
- •pregnancy.
研究组 & 干预措施
Clopidogrel - Repeated Loading Dose
repeated loading dose of clopidogrel (600 mg) in addition to high dose of clopidogrel continuous therapy for 30 days (150 mg/day)
干预措施: Clopidogrel (Drug)
Clopidogrel - standard of care
no repeated loading dose of clopidogrel with clopidogrel continuous therapy for 30 days (75 mg/day)
干预措施: Clopidogrel (Drug)
结局指标
主要结局
inhibition of platelet aggregation
时间窗: at 24th hour after administration of the repeated loading dose of clopidogrel / placebo
inhibition of platelet aggregation at 24th hour after administration of the repeated loading dose of clopidogrel / placebo
次要结局
- Secondary outcome(30 days)