A Single-center, Prospective,Randomized Study of Antiplatelet Effects of Ticagrelor Versus Clopidogrel in Patients With Dual Anti-platelet Therapy After Coronary Artery Bypass Grafting
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 137
- 试验地点
- 1
- 主要终点
- IPA at 2hours
研究概览
简要总结
This study is designed to demonstrate that the onset of the antiplatelet effect of 90mg bid dose ticagrelor is more rapid and greater than 75 mg qd dose clopidogrel in patients undergoing CABG surgery.
详细描述
Patients undergoing coronary artery surgery routinely receive aspirin therapy, as a standard treatment for preserving bypass graft patency. Although the dual antiplatelet therapy post CABG has not been recommended by guideline, present studies indicated the patients could benefit from the dual anti-platelet therapy. Using clopidogrel+aspirin could significantly reduce the early saphenous vein graft occlusion. . Many surgeons empirically prescribe dual anti-platelet therapy in spite of the indeterminacy of the clinical effects. ticagrelor is a novel, reversibly binding, oral, direct-acting P2Y12-receptor antagonist. The ONSET/OFFSET Study also shows that ticagrelor achieved much rapid and greater platelet inhibition than high-loading-dose clopidogrel in patients with stable CAD. ticagrelor is a novel, reversibly binding, oral, direct-acting P2Y12-receptor antagonist. The ONSET/OFFSET Study also shows that ticagrelor achieved much rapid and greater platelet inhibition than high-loading-dose clopidogrel in patients with stable CAD.
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 (Investigator)
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
- •Female and/or male and ≥ 18 and <80 years of age
- •Isolated CABG for the first time
- •either on- or off- pump
排除标准
- •Combined valvular surgery.
- •A second surgery.
- •Emergency surgery (a selective operation which change to emergency surgery in some special medical condition).
- •Serum creatinine>130μmol/L.
- •Oral clopidogrel therapy stops less than 5 days before the surgery.
- •Oral anti-coagulation therapy (warfarin) that cannot be withheld.
- •History of gastrointestinal or vaginal bleeding, Active pathological bleeding (e.g. active gastroduodenal ulcer or cerebral haemorrhage), history of postoperative gastrointestinal bleeding.
- •Uric acid nephropathy, history of postoperative gastrointestinal bleeding.
- •History of cerebral haemorrhage.
- •Any other condition that may influence platelet count and function.
- •Postoperative chest drainage > 200 ml/hr for two hours and more, re-operation for bleeding with persistent cardiac tamponade.
- •Treated with IABP or ECMO after operation.
- •Any other condition that may put the patient at risk (e.g., recurrent ventricular arrhythmias, peri-operative myocardial infarction, cancer).
- •Contraindication to aspirin, clopidogrel and ticagrelor or other reason that study drug should not be administered (e.g., hypersensitivity, moderate or severe liver disease).
- •Previous enrollment in other investigational drug or device study within 30 days.
- •Being or planning to pregnant.
研究组 & 干预措施
ticagrelor
90mg Bid for 30days after first dose
干预措施: ticagrelor (Drug)
clopidogrel
75mg Qd for 30days first dose
干预措施: clopidogrel (Drug)
asprin
100mg Qd all patients will be given asprin 100mg Qd within 24hours after CABG
干预措施: asprin (Drug)
结局指标
主要结局
IPA at 2hours
时间窗: 2 hours after the first dose of study drug
the platelet inhibition (IPA %) measured by light-transmittance aggregometry at 2 hour in CABG patients after the first dose of study drug
次要结局
- the platelet reactivity index at 0h, 2h, 8h, 24h，3day, and 30days(0h, 2h, 8h, 24h，3day, and 30day after the first dose of study drug)
- the inhibition of platelet function (IPA%) measured by LTA at 0h, 8h, 24h, 3day, and 30day after the first dose of study drug(0h, 8h, 24h, 3day, and 30day after the first dose of study drug)
研究者
Zhe zheng
Cardiovascular Surgeon Professor
Chinese Academy of Medical Sciences, Fuwai Hospital