Platelet Reactivity in Patients With Chronic Kidney Disease Receiving Adjunctive Cilostazol Compared to a High-maintenance Dose of Clopidogrel
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- The differences of platelet aggregation according to the anti-platelet therapy.
研究概览
简要总结
Impaired renal function is associated with reduced responsiveness to clopidogrel. There are no studies which have shown a means by which to overcome platelet hyporesponsiveness in patients with chronic kidney disease (CKD). The purpose of this study was to determine the functional impact of cilostazol in patients with CKD undergoing hemodialysis.
详细描述
The aims of this study is to evaluate the effects of platelet responsiveness to clopidogrel or cilostazol in CKD patients undergoing hemodialysis. The differences in platelet activation markers are also evaluated before and after clopidogrel or cilostazol administration. The investigators will perform a prospective, randomized study to compare the degree of platelet inhibition and platelet activation markers by adjunctive cilostazol (100 mg twice daily) compared to clopidogrel (75 or 150 mg/day) in CKD patients undergoing hemodialysis.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CKD patients undergoing chronic hemodialysis and PCI for stable coronary artery disease
排除标准
- •known allergies to aspirin, clopidogrel, or cilostazol thienopyridine use before enrollment
- •concomitant use of other anti-thrombotic drugs (oral anticoagulants and dipyridamole)
- •platelet count <100 x 106/μL
- •hematocrit < 25%
- •liver disease (bilirubin > 2 mg/dl)
- •active bleeding or bleeding diathesis
- •gastrointestinal bleeding within the last 6 months
- •hemodynamic instability
- •acute coronary or cerebrovascular event within 3 months
- •malignancy
- •concomitant use of a cytochrome P450 inhibitor or a non-steroidal anti-inflammatory drug
- •recent treatment (<30 days) with a glycoprotein IIb/IIIa antagonist.
研究组 & 干预措施
clopidogrel 75 mg/day
CKD patients undergoing chronic hemodialysis and PCI for stable coronary artery disease will be randomized to receive clopidogrel 75 mg/day for 14 days.
干预措施: Clopidogrel, cilostazol (Drug)
clopidogrel 150 mg/day
CKD patients undergoing chronic hemodialysis and PCI for stable coronary artery disease will be randomized to receive clopidogrel 150 mg/day for 14 days.
干预措施: Clopidogrel, cilostazol (Drug)
adjunctive cilostazol
CKD patients undergoing chronic hemodialysis and PCI for stable coronary artery disease will be randomized to receive co-administration of adjunctive cilostazol (100 mg twice daily) and clopidogrel (75 mg/day; [group 3, 20 patients]) for 14 days.
干预措施: Clopidogrel, cilostazol (Drug)
75mg clopidogrel
control group undergoing PCI for stable angina will be also maintained on clopidogrel (75 mg/day for 14 days).
干预措施: Clopidogrel, cilostazol (Drug)
结局指标
主要结局
The differences of platelet aggregation according to the anti-platelet therapy.
时间窗: 14 days
Platelet function was assessed with light transmittance aggregometry and the VerifyNowTM P2Y12 assay. High on-treatment platelet reactivity was defined as 5 μmol/L of ADP-induced Aggmax \> 50%. Inhibition of platelet aggregation (IPA) was defined as the percent decrease in aggregation values obtained at baseline and after treatment. VerifyNow-P2Y12 assay results are also assessed and expressed in P2Y12 reaction units (PRUs) and the percentage of inhibition.
次要结局
- Changes of platelet activation markers according to the anti-platelet therapy(14 days)