A Double-Blind, Randomized Comparison Between Two Different Clopidogrel Maintenance Doses After Percutaneous Coronary Intervention (ISAR-CHOICE-2)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Maximal ADP(5µmol/l)-induced platelet aggregation 30 days after the intervention
研究概览
简要总结
The purpose of the study is to test whether an increase of the maintenance dose of clopidogrel from 75 to 150 mg per day results in an additional suppression of ADP-induced platelet aggregation
详细描述
In patients treated with coronary stents clopidogrel therapy is usually initiated with a 300 to 600 mg loading dose. In the CREDO trial it was shown that a 300 mg loading dose results in a reduction of ischemic events after percutaneous coronary intervention (PCI) if given 6 hours prior to the procedure. An antiplatelet effect similar to that achieved by chronic therapy with 75 mg/day is reached within 2 hours when the high 600 mg loading is administered. The 600 mg loading dose has been shown to be safe and effective in preventing thrombotic events following coronary stent implantation. Recently, it was shown that in patients with stable angina and administration of the 600 mg loading dose at least two hours prior to PCI concomitant therapy with a GP IIb/IIIa antagonist does not result in a further reduction of the incidence of thrombotic events. In contrast to a number of investigations with different loading doses, no trials have been performed comparing different clopidogrel maintenance doses. Recently, it was shown that administration of a 600 mg loading dose in patients already on chronic clopidogrel therapy (75 mg/day) results in an additional significant increase in inhibition of adenosine diphosphate (ADP-) induced platelet aggregation. Therefore, it is possible that an increase of the clopidogrel maintenance dose in patients with chronic clopidogrel therapy also results in a more pronounced inhibition of platelet aggregation.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients with chronic aspirin therapy who are treated with percutaneous coronary intervention at least 2 hours after administration of a 600 mg loading dose of clopidogrel
排除标准
- •Major alterations of blood count (particularly platelet count < 100x10^9/l, haemoglobin < 10 mg/dl
- •Recent bleeding diathesis
- •Presence of a hematologic or malignant disorder
- •Oral anticoagulation with coumarin derivates
- •Use of glycoprotein (GP) IIb/IIIa antagonists during the intervention or during the preceding 14 days
- •Therapy with clopidogrel within the last 28 days
研究组 & 干预措施
1
75 mg Clopidogrel Maintenance Doses
干预措施: Clopidogrel (Drug)
2
150 mg Clopidogrel Maintenance Doses
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Maximal ADP(5µmol/l)-induced platelet aggregation 30 days after the intervention
时间窗: 30 days after the intervention
次要结局
- P2Y12 inhibition measured by point-of-care test(P2Y12 inhibition measured by point-of-care test)
- Maximal ADP(20µmol/l)-induced platelet aggregation 30 days after the intervention(30 days after the intervention)
