Clinical Assessment of Pidogrel® Versus Plavix®
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 219
- 试验地点
- 1
- 主要终点
- - study the respective effects of Pidogrel ® and Plavix ® on platelet aggregation through the test VerifyNow ® - Time to first occurrence of post-randomization major adverse cardiac events (MACE)
研究概览
简要总结
This study aims to demonstrate non-inferiority of Pidogrel ® compared to Plavix ® in patients with coronary disease:
- Primary Outcome Measures: measure of platelet reactivity by VerifyNow assay after 600 mg loading dose or after the last maintenance dose (75 mg).
- Secondary Outcome Measures: Time to first occurrence of major cardio-vascular events (MACE).
- Safety Criteria: severe bleeding (GUSTO scale).
详细描述
after randomization of patients in both groups (Plavix or Pidogrel), the measure of platelet activity by the VerifyNow assay, 4 to 12 hours after the loading dose of 600mg or after the last dose of clopidogrel for patients on maintenance dose. The VerifyNow assay will determine: - The PRU:-P2Y12 Reaction Units-
-% Of platelet inhibition It will be considered low responder or clopidogrel resistant patient with PRU> 235 or %inhibition <15%.
Monitoring of patients included in the study will take place over a period of 12 months, MACE will be notified and dated. MACE criteria are: angina, myocardial infarction, coronary angioplasty, coronary artery bypass graft, and stroke.
Each hemorrhagic event will be notified and classified according to the GUSTO scale.
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
- •Male or female,
- •Old (e) over 20 years
- •Patients hospitalized for acute coronary syndrome (Whatever the T and troponin)
- •Patients with proven coronary candidates for treatment with clopidogrel (who received a loading dose of 600mg over 2 hours and treated with 75mg / d of clopidogrel for longer than 7 days)
排除标准
- •Patients unwilling.
- •Patient participating in another study.
- •Patients with cardiogenic shock
- •Patient on anti GpIIbIIIa or stopped less than 72 hours before the test aggregability
- •Patients scheduled for surgery in less than 6 months.
- •Patients candidates for coronary angioplasty
- •Patients who underwent TAC + / - bare stent fewer than 30 days.
- •Patients who underwent stenting with ATC active there is less than 12 months.
- •ischemic stroke older than 6 weeks.
- •History of hemorrhagic stroke (any time)
- •Patients on warfarin or candidates
- •Patients with a different anti ADP (ticlopidine, prasugrel)
- •Patients with indication for clopidogrel-cons (side effects, bleeding ...)
- •Thrombocytopenia <100000/mm3
- •anemia (Ht <30%)
- •Thrombocythaemia (Ht> 52%)
- •Patients seeking treatment for an elective forms of Clopidogrel.
- •Pregnancy
研究组 & 干预措施
plavix
patient treated by the princeps
干预措施: Plavix (Drug)
Pidogrel
patient treated by Pidogrel
干预措施: Pidogrel (Drug)
结局指标
主要结局
- study the respective effects of Pidogrel ® and Plavix ® on platelet aggregation through the test VerifyNow ® - Time to first occurrence of post-randomization major adverse cardiac events (MACE)
时间窗: 06 months
次要结局
未报告次要终点