NCT01175200已完成不适用
Double the Dose of Clopidogrel or Switch to Prasugrel to Antagonize Proton Pump Inhibitor Interaction. A Prospective, Mono-center, Placebo- and Active Treatment-controlled, Randomized, Cross Over Study.
Ascopharm Groupe Novasco1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2010年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Change in antiplatelet effect of clopidogrel
研究概览
简要总结
This study will establish the optimal therapeutic strategy for patients with a coronary artery disease (CAD) and chronically treated with clopidogrel 75 mg/day requiring co-administration of an anti-platelet treatment with P2Y12 antagonist and a PPI for treatment/prevention of GI ulceration.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Personal or family history of coagulation or bleeding disorders
- •Use of known inhibitors or inducers of CYP2C19 and CYP3A including grape fruit juice intake
- •Known hypersensitivity to lansoprazole, its excipients, or substituted benzimidazoles,
- •Known hypersensitivity to clopidogrel / prasugrel
- •Anti-platelet treatment other than clopidogrel + aspirin within 7 days before inclusion
- •Any formal indication to maintain PPI treatment
- •PPI within 15 days before inclusion in the study
- •Active pathology with 10 days before inclusion
- •Prior history of stent thrombosis
- •Prior history of Stroke
- •Employee of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
研究组 & 干预措施
Prasugrel
Active Comparator
干预措施: Prasugrel (Drug)
Clopidogrel
Active Comparator
干预措施: Clopidogrel (Drug)
Lansoprazole
Active Comparator
proton pump inhibitor
干预措施: Lansoprazole (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in antiplatelet effect of clopidogrel
时间窗: 14 days
change in antiplatetelet effect of clopidogrel as compared to prasugrel when associated to lansoprazole (or placebo) in patients with stable angina
次要结局
- high on-treatment platelet reactivity Clopidogrel pharmacokinetics responses(14 days)
研究者
研究点 (1)
Loading locations...
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