Relationship of Dose of Ticagrelor and Anti-inflammatory Effect in Patients With End Stage Renal Disease on Hemodialysis: PIANO-6 Randomized Crossover Study
试验速览
- 阶段
- 3 期
- 入组人数
- 25
- 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
Antiplatelet treatment in patients with end stage renal disease (ESRD) on hemodialysis (HD) is still challenging because of bleeding and thrombotic complications. The investigators hypothesized ticagrelor once daily dose would achieve tolerable antiplatelet effects compared with ticagrelor twice a day dose 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. 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. The investigators recently reported platelet inhibition by ticagrelor was faster and markedly greater than by clopidogrel with onset dosing regimen in patients with ESRD on HD. However, few studies have been conducted whether platelet reactivity during ticagrelor treatment is associated with endothelial function, platelet activation markers and inflammation status in ESRD patients on HD. Additionally, the dose dependent effects of ticagrelor have been rarely evaluated.
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
Ticagrelor 90 mg
After randomization, an initial loading dose of ticagrelor (180 mg) was given and low dose ticagrelor (ticagrelor 90 mg once a day) was treated for 14 days.
干预措施: Ticagrelor (Drug)
Ticagrelor 180 mg
After randomization, an initial loading dose of ticagrelor (180 mg) was given and usual dose ticagrelor (ticagrelor 90 mg twice a day) was treated for 14 days.
干预措施: Ticagrelor (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 difference of antiplatelet effects assessed by light aggregometry assay(14 days after study drug treatment)
- The difference of endothelial function assessed by forearm flow-mediated vasodilation (FMD) and peripheral arterial tonometry (PAT)(14 days after study drug treatment)
- The difference of anti-inflammatory biomarkers(14 days after study drug treatment)
研究者
Weon Kim
Professor
Kyunghee University Medical Center