Platelet Reactivity in Patients With End Stage Renal Disease Receiving Clopidogrel Compared With Ticagrelor
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- The difference of antiplatelet effects assessed by VerifyNow assay
研究概览
简要总结
Patients with severe chronic kidney disease or end stage renal disease (ESRD) on hemodialysis (HD) exhibited higher platelet reactivity to clopidogrel than did those with normal renal function. Not enough study has been conducted about the antiplatelet effects of ticagrelor in these cardiovascular high risk patients. We hypothesized ticagrelor would achieve more and faster antiplatelet effects compared with clopidogrel in ESRD patients on HD.
详细描述
Chronic kidney disease (CKD) is a strong risk factor for cardiovascular morbidity and mortality, and confers an increasing risk of stent thrombosis even when dual antiplatelet therapy (clopidogrel and aspirin) is administered. Recently, we demonstrated that patients with severe CKD or end stage renal disease (ESRD) on hemodialysis (HD) exhibited higher platelet reactivity to clopidogrel than did those with normal renal function. One of good option to overcome high platelet reactivity in ESRD patients would be ticagrelor which has been already shown improved clinical outcomes. But little is known the antiplatelet effects of ticagrelor in ESRD patients on HD. The present study was designed to determine the antiplatelet effect as well as the onset and offset action of ticagrelor compared with clopidogrel in patients with ESRD undergoing maintenance HD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •ESRD patients undergoing regular (≥ 6 months) maintenance HD
- •ongoing (≥ 2 months) treatment with clopidogrel
- •P2Y12 reaction units (PRUs) were more than 235
排除标准
- •known allergies to aspirin, clopidogrel, or ticagrelor
- •concomitant use of other antithrombotic drugs (oral anticoagulants, dipyridamole)
- •thrombocytopenia (platelet count <100,000/mm3)
- •hematocrit <25%
- •uncontrolled hyperglycemia (hemoglobin A1c >10%)
- •liver disease (bilirubin level >2 mg/dl)
- •symptomatic severe pulmonary disease
- •active bleeding or bleeding diathesis
- •gastrointestinal bleeding within the last 6 months
- •hemodynamic instability
- •acute coronary or cerebrovascular event within the last 3 months
- •pregnancy
- •any malignancy
- •concomitant use of a cytochrome P450 inhibitor or nonsteroidal anti-inflammatory drug
- •recent treatment (<30 days) with a glycoprotein IIb/IIIa antagonist
研究组 & 干预措施
Clopidogrel
Patients treated with clopidogrel for 14 days
干预措施: Ticagrelor (Drug)
Clopidogrel
Patients treated with clopidogrel for 14 days
干预措施: Clopidogrel (Drug)
Ticagrelor
Patients treated with ticagrelor for 14 days
干预措施: Ticagrelor (Drug)
Ticagrelor
Patients treated with ticagrelor for 14 days
干预措施: Clopidogrel (Drug)
结局指标
主要结局
The difference of antiplatelet effects assessed by VerifyNow assay
时间窗: 14 days after study drug treatment
The difference of PRU values achieved following antiplatelet therapy
次要结局
- the rate of onset and offset of the antiplatelet effects(14 days after study drugs treatment)
研究者
Weon Kim
Professor
Kyunghee University Medical Center