Dual Antiplatelet Therapy With Ticagrelor and Acetylsalicylic Acid (ASA) vs. ASA Only After Isolated Coronary Artery Bypass Grafting in Patient With Acute Coronary Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,201
- 试验地点
- 22
- 主要终点
- Time to major adverse cardiovascular events (MACE)
研究概览
简要总结
The study is a Randomised Registry-based Clinical Trial (RRCT) to assess whether dual antiplatelet therapy with ticagrelor and ASA compared to ASA alone improves outcome after isolated CABG in patients with acute coronary syndrome.
详细描述
The trial is a 1:1 randomized, interventional, multi-national, multi-center, safety/efficacy, parallel assignment, open-label treatment study and will use the RRCT methodology. A RRCT study utilizes existing health care registry platforms to conduct a pragmatic prospective randomized trial.
After the CABG, eligible patients that have consented to the study, will be randomized to either treatment arms. In the intervention arm, patients will be treated with ticagrelor 90 mg twice daily and ASA 75-100 mg daily for 12 months and patients in the control arm will get ASA only (75-160 mg daily according to local guidelines) during the same time period.
The patients will be followed by telephone interviews at 30 days and 365 days after inclusion. After the treatment period patients will be followed during an observation period by collection of outcome data from registries or medical records, 24, 36, 60 and 120 months after inclusion of the patient. No other data but the registry data or data from medical records will be collected.
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
- None
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
- •Written informed consent
- •Age ≥18 years
- •Has undergone first time isolated CABG due to an episode of acute coronary syndrome (STEMI, NSTEMI, unstable angina) within 6 weeks before surgery
排除标准
- •Previously enrolled in this study (i.e. patient now at repeat encounter)
- •Concomitant surgical procedure other than CABG
- •Anticoagulant treatment after the operation (e.g. warfarin, direct thrombin inhibitors (dabigatran), FXa inhibitors (rivaroxaban, apixaban, heparin, low-molecular weight heparin, fondaparinux)
- •Discharge from the operating hospital to an ICU at another hospital
- •Pregnancy or lactation
- •Known intolerance or contraindication to ticagrelor or ASA
- •Any disorder that may interfere with drug absorption
- •Any condition other than coronary artery disease with a life expectancy <12 months
- •Known chronic liver disease, renal disease requiring dialysis or bleeding disorder
- •Atrioventricular block II and III in patients without pacemaker
- •Any other indication for dual antiplatelet therapy, i.e. recent stent implantation
- •Debilitating stroke within 90 days before inclusion
- •Previous intracranial bleeding
- •Treatment with immunosuppressants (e.g. cyclosporine and tacrolimus)
- •Treatment with strong CYP3A4-inhibitors (e.g. ketoconazole, clarithromycin, nefazodone, ritonavir or atazanavir)
- •Any condition that in the opinion of the investigator may interfere with adherence to trial protocol
- •Participation in any other clinical trial evaluating investigational products at the time for enrollment in this study
研究组 & 干预措施
Dual antiplatelet therapy
Ticagrelor 90 mg twice daily and ASA 75-100 mg daily for 12 months
干预措施: Ticagrelor 90mg twice daily and ASA 75-100 mg daily (Drug)
Acetylsalicylic acid
ASA 75-160 mg daily for 12 months
干预措施: ASA 75-160 mg daily (Drug)
结局指标
主要结局
Time to major adverse cardiovascular events (MACE)
时间窗: within12 months
To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone improves 12 months outcome defined as time to major adverse cardiovascular events (MACE) after isolated CABG in ACS patients. MACE includes all-cause mortality, myocardial infarction, stroke and new revascularization.
次要结局
- Time to hospitalization for heart failure(within 12 months)
- Time to cardiovascular hospitalization(within 12 months)
- Time to all cause death(within 12 months)
- Time to all cause death, myocardial infarction or stroke(within 12 months)
- Time to cardiovascular death(within 12 months)
- Time to first myocardial infarction(within 12 months)
- Time to sudden death or aborted cardiac arrest(within 12 months)
- Time to new-onset atrial fibrillation(within 12 months)
- Time to major bleeding defined as bleeding requiring hospitalization(within 12 months)
- Time to minor bleeding(within 12 months)
- Time to first stroke(within 12 months)
- Time to new revascularization(within 12 months)
- Time to coronary angiography(within 12 months)
- Time to dyspnea(within 12 months)
- Time to any bleeding(within 12 months)
- Time to dyspnea causing drug interruption(within 12 months)
- Time to new onset renal failure(within 12 months)
- Time to major adverse cardiovascular events (MACE)(2, 3, 5 and 10 years after the patient has been included in the study)