The Effect Of Antiplatelets Therapy, Tirafiban, Prasugrel, And Aspirin On Saphenous Vein Coronary Artery Bypass Graft Patency
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Venous graft patency
研究概览
简要总结
This protocol is designed to evaluate the effect of antiplatelets (Tirafiban and Prasugrel) on the incidence of early and intermediate graft patency after CABG.
详细描述
Coronary artery bypass graft (CABG) surgery is a commonly used revascularization strategy in patients with severe coronary artery disease. Saphenous vein grafts (SVGs) are the most frequently used conduits for this procedure. Unlike arterial grafts, SVGs are particularly susceptible to occlusive thrombosis during the first post-operative year, which exposes patients to increased risks of death, myocardial infarction, and repeat revascularization.
This study is designed to evaluate the effect of antiplatelets (Tirafiban and Prasugrel) on the incidence of early and intermediate graft patency after CABG. Patients will undergo planned cardiac Computed tomographic angiography (CTA) predischarge (at 1 week) and CTA/coronary angiography (CAG) at 6 months to 1 year follow-up. CTA at baseline (predischarge) and follow-up CTA/CAG at 6-12 months after CABG will be used to evaluate graft patency.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All comer study where all patients undergoing coronary bypass surgery (CABG) will be randomized to one of the four treatment groups
排除标准
- •Acute myocardial infarction (AMI) or cardiogenic shock
- •Aortic dissection
- •Mechanical valves.
- •Contraindication to antiplatelets or aggrastat.
- •Active bleeding or high risk of bleeding.
- •History of hemorrhagic stroke any time.
- •Recent history of embolic stroke or transient ischemic attack (TIA) less than 3 months.
- •Active peptic ulcer disease (PUD).
- •Liver derangement.
- •Warfarin use.
- •Heparin-induced thrombocytopenia (HIT) syndrome.
- •Thrombocytopenia (platelet count <100,000/mm3), disorders of platelet function
研究组 & 干预措施
Aspirin alone
干预措施: Aspirin (Drug)
Aspirin alone
干预措施: Tirofiban (Drug)
Aspirin alone
干预措施: Clopidogrel (Drug)
Aspirin alone
干预措施: Prasugrel (Drug)
Tirofoban
Patient assigned to this arm will receive tirofiban infusion starting approximately six hours post bypass surgery once hemomstasis established and no evidence of bleeding
干预措施: Tirofiban (Drug)
Tirofoban
Patient assigned to this arm will receive tirofiban infusion starting approximately six hours post bypass surgery once hemomstasis established and no evidence of bleeding
干预措施: Clopidogrel (Drug)
Tirofoban
Patient assigned to this arm will receive tirofiban infusion starting approximately six hours post bypass surgery once hemomstasis established and no evidence of bleeding
干预措施: Prasugrel (Drug)
Clopidogrel
Patients receive oral clopidogrel 75 mg 6-8 hours before coronary bypass surgery and continue daily mentenance dose as per instruction by investigators
干预措施: Tirofiban (Drug)
Clopidogrel
Patients receive oral clopidogrel 75 mg 6-8 hours before coronary bypass surgery and continue daily mentenance dose as per instruction by investigators
干预措施: Clopidogrel (Drug)
Clopidogrel
Patients receive oral clopidogrel 75 mg 6-8 hours before coronary bypass surgery and continue daily mentenance dose as per instruction by investigators
干预措施: Prasugrel (Drug)
Prasugrel
Patients started on prasugrel 6 hours post surgery 10 mg then continue on daily 10mg as per instruction by investigators
干预措施: Tirofiban (Drug)
Prasugrel
Patients started on prasugrel 6 hours post surgery 10 mg then continue on daily 10mg as per instruction by investigators
干预措施: Clopidogrel (Drug)
Prasugrel
Patients started on prasugrel 6 hours post surgery 10 mg then continue on daily 10mg as per instruction by investigators
干预措施: Prasugrel (Drug)
结局指标
主要结局
Venous graft patency
时间窗: At one year
Venous graft patency as assessed by computed tomographic angiography or coronary angiography
次要结局
- Major cardiac events (MACE)(At one year)
研究者
Abdulrahman Al-Moghairi
Principal Investigator
Prince Sultan Cardiac Center, Adult Cardiology Department.