One Month Dual Antiplatelet Therapy With Ticagrelor in Coronary Artery Bypass Graft Patients
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 700
- 试验地点
- 22
- 主要终点
- Hierarchical composite of time to death, stroke, myocardial infarction, repeat revascularization and any graft failure.
研究概览
简要总结
The purpose of this study is to compare the effect of ticagrelor plus low-dose aspirin versus low-dose aspirin alone in patients with chronic coronary disease undergoing coronary artery bypass grafting.
详细描述
A multinational, randomized trial to evaluate the effect of one-month of ticagrelor plus low-dose aspirin, versus low-dose aspirin alone, on the incidence of death, myocardial infarction, stroke, repeat revascularization and graft failure in patients with chronic coronary disease undergoing coronary artery bypass grafting.
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
- None (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
- •Age ≥18 years
- •Elective first-time CABG with use of ≥1 saphenous vein graft;
- •Ability to sign informed consent and comply with all study procedures, including follow-up for at least 5 years.
排除标准
- •Any indication for dual antiplatelet therapy, including
- •Acute/recent (within 1 year) ACS (NSTE-ACS or STEMI)
- •Recent PCI requiring continuation of dual antiplatelet therapy after CABG
- •Current or anticipated use of oral anticoagulation;
- •Paroxysmal, persistent or permanent atrial fibrillation;
- •Any concomitant cardiac or non-cardiac procedure;
- •Planned cardiac or non-cardiac surgery within one year;
- •Preoperative end-organ dysfunction (dialysis, moderate to severe liver failure, respiratory failure), cancer or other non-cardiac comorbidity with a life expectancy <5 years;
- •Inability to use the saphenous vein;
- •Contraindications to the use of aspirin;
- •Contraindications to the use of ticagrelor, including
- •Known hypersensitivity to ticagrelor
- •Active pathological bleeding (including, but not limited to gastrointestinal or intracranial bleeding)
- •History of intracranial hemorrhage
- •Concomitant therapy with strong CYP3A4 inhibitors (eg ketoconazole, clarithromycin, nefazodone, ritonavir, atazanavir)
- •Inability to undergo coronary computed tomographic angiography (CCTA);
- •Participating in another investigational device or drug study;
- •Women of childbearing potential
- •Any major perioperative complication including, but not limited to, stroke, TIA, MI, CABG-related bleeding (BARC type 4), sepsis.
研究组 & 干预措施
Low-Dose Aspirin Alone
干预措施: Low-dose aspirin (Drug)
Ticagrelor 90 mg + Low-Dose Aspirin
干预措施: Ticagrelor 90 MG (Drug)
Ticagrelor 90 mg + Low-Dose Aspirin
干预措施: Low-dose aspirin (Drug)
结局指标
主要结局
Hierarchical composite of time to death, stroke, myocardial infarction, repeat revascularization and any graft failure.
时间窗: 1 year
This is a composite endpoint to be compared between groups in a hierarchical order using the win ratio method. The following hierarchy is pre-specified: 1. Time to all-cause mortality 2. Time to stroke 3. Time to myocardial infarction 4. Time to coronary revascularization 5. Presence of graft failure at 12-month imaging follow-up or on unscheduled imaging prior to 12 month
次要结局
- Hierarchical composite of time to death, stroke, myocardial infarction, Bleeding Academic Research Consortium (BARC) type 3 bleeding, repeat revascularization and any graft failure.(1 year)
- Hierarchical composite of time to death, stroke, myocardial infarction, repeat revascularization and 5-year time-averaged disease-specific (Seattle Angina Questionnaire [SAQ]-7) quality of life (QoL) score(5 years)
- Hierarchical composite of time to death, stroke, myocardial infarction, BARC type 3 bleeding, repeat revascularization and 5-year time-averaged SAQ-7 QoL score.(5 years)