Ticagrelor Versus High-dose Clopidogrel in Patients With High Platelet Reactivity on Clopidogrel After Percutaneous Coronary Intervention: The PL-PLATELET Randomized Trial
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- 12-Month Freedom From MACE
研究概览
简要总结
To determine the safety and efficacy of Ticagrelor versus Clopidogrel for the reduction of adverse cardiovascular outcomes in patients with high platelet reactivity on clopidogrel after successful implantation of coronary drug-eluting stents.
详细描述
This is a multi-center, randomized, single-blind, investigator-initiated study with a parallel design. Patients with coronary artery disease undergoing percutaneous coronary intervention and presenting high platelet reactivity on clopidogrel as assessed with the PL-11 analyzer (platelet maximum aggregation ratio [MAR%] ≥ 55 %) at 2 hours post-clopidogrel 300mg LD (Day 0), will be randomized after informed consent, in a 1:1 ratio to the following treatment groups:
Group Α: Ticagrelor 180 mg immediate loading (on Day 0) followed by 180mg/day starting from Day 1 until Day 365 (12 months after randomization).
Group Β: Clopidogrel 150mg per day, starting from Day 1 until Day 365 (12 months after randomization).
Platelet reactivity assessment will be performed before randomization (Day 0), and 3-day after randomization (Day 3). Documentation of major adverse cardiac and cerebrovascular events (death, myocardial infarction, stent thrombosis, stroke, revascularization procedure with PCI or CABG) and serious adverse events (bleeding, other adverse events) will be performed until 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who agreed to the experimental plan which was permitted by IRB;
- •Patients planned to take dual antiplatelet therapy for 12 months.
排除标准
- •Severe hepatic dysfunction defined as serum transaminase > 3 times normal limit;
- •Renal dysfunction defined as eGFR < 30ml/min/1.73m^2;
- •Co-morbidity with an estimated life expectancy of < 50 % at 12 months;
- •Scheduled surgery in the next 12 months, which resulted protocol changes;
- •Known allergy against study drug or device;
- •Use of glycoprotein IIb/IIIa inhibitor during the perioperative period;
- •Anticoagulation treatment including warfarin.
研究组 & 干预措施
Ticagrelor
Administration of ticagrelor 180mg/day for 12 months.
干预措施: Ticagrelor (Drug)
Clopidogrel
Administration of clopidogrel 150 mg/day for 12 months
干预措施: Clopidogrel (Drug)
结局指标
主要结局
12-Month Freedom From MACE
时间窗: 12 months
Major adverse cardiovascular and cerebrovascular events consist of all-cause death, target vessel myocardial infarction, stroke, stent thrombosis.
次要结局
- 12-Month Freedom From MI(12 months)
- 12-Month Freedom From Mortality(12 months)
- 12-Month Freedom From Cardiac death(12 months)
- 12-Month Freedom From TLR(12 months)
- 12-Month Freedom From TVR(12 months)
- 12-Month Freedom From Stroke(12 months)
- 12-Month Freedom From Stent Thrombosis(12 months)
研究者
Shaoliang Chen, MD
Vice President
Nanjing First Hospital, Nanjing Medical University