A Randomized, Parallel Group, Double-Blind Study of Ticagrelor Compared With Aspirin for Prevention of Vascular Events in Patients Undergoing Coronary Artery Bypass Graft Operation TiCAB- Ticagrelor in CABG
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 1,893
- 试验地点
- 29
- 主要终点
- MACCE
研究概览
简要总结
The primary objective of this study ist to test the hypothesis that ticagrelor is superior to Aspirin (ASA) fort he prevention of major cardio- and cerebrovascular events (MACCE) in patients undergoing artery bypass operation.
The primary efficiacy MACCE-endpoint is the composite of cardiovascular death, myocardial infarction, recurent revascularisation, and stroke at twelve month after coronary artery bypass operation.
详细描述
For stable patients who underwent coronary bypass operation, Aspirin alone currently represents the gold standard of antiplatelet treatment.
The CABG substudy of the PLATO-trial (http://www.nejm.org/doi/full/10.1056/NEJMoa0904327) comprising more than 1200 patients has convincingly shown a high significant reduction of cardiovascular and all-cause mortality for patients recieving Aspirin and Ticagrelor as compared to those subjects randomized to Aspirin plus Clopidogrel. Moreover the results of the PLATO CABG substudy showed that benefits of Ticagrelor increase with decreasing Aspirin doses. Therefore Ticagrelor monotherapy (2x 90mg/day) appears to offer the best balance of safety with anticipated improved efficacy over Aspirin (1x 100mg/day) alone, but until now there are no further data available to support this hypothesis.
Hence this study (TiCAB) is assigned as a pivotal efficacy and safety study of Ticagrelor in patients undergoing coronary artery bypass operation and to test the hypothesis that ticagrelor is superior to Aspirin for the prevention of major cardio- and cerebrovascular events (MACCE) in this patient population.
The TiCAB trial is designed as a randomized, double-blind, double-dummy, parallel group, phase III, multicenter study, comparing the efficacy and safety of Ticagrelor 90mg administered twice daily with Aspirin 100mg once daily, for the prevention of MACCE within the first year after CABG operation.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years of age or older
- •Informed, written consent by the patient
- •Indication for CABG surgery:
- •coronary three vessel disease, or
- •left main stenosis, or
- •two vessel disease with impaired left ventricular function (<50%)
排除标准
- •Cardiogenic shock, haemodynamic instability
- •Indication for oral anticoagulation or dual antiplatelet therapy that can not be stopped after CABG
- •Need for concomitant non-coronary surgery (e.g. valve replacement)
- •Intolerance of or Allergy to Ticagrelor or ASA or any of their ingredients
- •History of bleeding diathesis within three months prior presentation
- •History of significant gastrointestinal bleeding within six months prior presentation
- •History of intracranial hemorrhage
- •History of moderate to severe liver impairment (Child Pugh B or C)
- •Chronic renal insufficiency requiring dialysis
- •Patient with an increased risk of bradycardic events (e.g. patients without a pacemaker who have sick sinus syndrome, 2nd or 3rd degree AV block or bradycardic-related syncope)
- •Known, clinically important thrombocytopenia (i.e. <100.000/µl)
- •Known, clinically important anaemia (i.e. <10mg/dl)
- •Participation in another investigational drug or device study in the last 30 days
- •Pregnancy or lactation (for premenopausal women 2 methods of reliable contraception, one of which must be barrier method, are required); in women with childbearing potential a pregnancy test is mandatory
- •Concomitant oral or intravenous therapy (see examples below) with strong CYP3A inhibitors, CYP3A substrates with narrow therapeutic indices, or strong CYP3A inducers which cannot be stopped for the course of the study
- •Strong inhibitors: ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, over 1 litre daily of grapefruit juice.
- •Substrates with narrow therapeutic index: cyclosporine, quinidine.
- •Strong inducers: rifampin/rifampicin, phenytoin, carbamazepine.
- •Life expectancy less than 12 months that may result in protocol non-compliance or a risk for being lost to follow-up, active cancer
- •Indication for major surgery (e.g. cancer treatment, carotid surgery, cerebral surgery, major vascular surgery)
- •Previous enrollment or randomization of treatment in the present study.
研究组 & 干预措施
Ticagrelor
Intervention: Drug: Ticagrelor verum + Aspirin placebo
干预措施: Placebo - Aspirin (Drug)
Aspirin
Intervention: Drug: Aspirin verum + Ticagrelor placebo
干预措施: Placebo - Ticagrelor (Drug)
Ticagrelor
Intervention: Drug: Ticagrelor verum + Aspirin placebo
干预措施: Ticagrelor (Drug)
Aspirin
Intervention: Drug: Aspirin verum + Ticagrelor placebo
干预措施: Aspirin (Drug)
结局指标
主要结局
MACCE
时间窗: at 12 months after coronary artery bypass surgery
Composite of cardiovascular death, myocardial infarction, target vessel revascularization, and stroke
次要结局
- Major bleeding events(within 12 months after coronary arerty bypass surgery)
- All cause death(at 12 months after coronary artery bypass surgery)
- Cardiovascular death(at 12 months after coronary artery bypass surgery)
- Stroke(at 12 months after coronary artery bypass surgery)
- Myocardial Infarction(at 12 months after coronary artery bypass surgery)
- Target Lesion Revascularization(at 12 months after coronary artery bypass surgery)