The Comparison of Effects Between Increased Dose of Clopidogrel and Addition of Cilostazol in Clopidogrel Non-Responders After Drug-Eluting Stent Implantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- % platelet inhibition with VeryfyNow-P2Y12 assay, platelet function test
研究概览
简要总结
To compare the effect of increased dosing of clopidogrel and adding cilostazol to standard dose of clopidogrel after the insertion of drug-eluting stent in patients with clopidogrel resistance
详细描述
Using dual antiplatelet agents with aspirin and clopidogrel is essential after drug-eluting stent implantation to prevent restenosis and stent thrombosis. However, variable platelet response and potential resistance to therapy have emerged with clopidogrel. Several studies showed that clopidogrel resistance is associated with increased cardiovascular events after coronary interventions. New antiplatelet therapeutic strategy of is needed in case of clopidogrel resistance. We started this study to compare the effect of double dosing of clopidogrel to 150mg per day and adding cilostazol to standard dose of clopidogrel after the insertion of drug-eluting stent in patients with clopidogrel resistance.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with clopidogrel resistance with treatment of dual antiplatelet agent, aspirin and clopidogrel, for more than 4 weeks after drug-eluting stent
- •Clopidogrel resistance is defined as a patients with platelet inhibition less than 30% in platelet function test(VerifyNow-P2Y12 assayTM, Accumetrics, San Diego, CA, USA)
排除标准
- •Acute myocardial infarction within 2 weeks
- •Unstable angina within 2 weeks
- •History of using glycoprotein IIb/IIIa inhibitor within 1 month
- •Cerebral infarction within 3 months
- •Bleeding diathesis like coagulation disorder, thrombocytopenia (platelet count < 100,000/uL)
- •history of gastrointestinal bleeding or genitourinary bleeding within 3 months
- •needed oral anticoagulation
- •aspirin, clopidogrel or cilostazol hypersensitivity
- •congestive heart failure
- •serum creatinine level >2mg/dl
- •malignancy
- •using cytochrome P450 inhibitor (eg, itraconazole)
研究组 & 干预措施
A
Aspirin plus increasing clopidogrel group
干预措施: aspirin, clopidogrel (Drug)
B
Aspirin, clopidogrel plus cilostazol group
干预措施: aspirin, clopidogrel, cilostazol (Drug)
结局指标
主要结局
% platelet inhibition with VeryfyNow-P2Y12 assay, platelet function test
时间窗: 4 weeks
次要结局
- P2Y12 reaction unit (PRU)(4 weeks)