Single Versus Dual Antiplatelet Therapy in Patients With Incomplete Revascularization After Coronary Artery Bypass Graft Surgery
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Cardiac-related mortality
研究概览
简要总结
The study aims to compare the efficacy of dual antiplatelet therapy (DAPT) over single antiplatelet therapy (SAPT) in patients with incomplete revascularization after coronary artery bypass graft surgery (CABG).
Before hospital discharge, patients will be 1:1 randomized to SAPT (acetylsalicylic acid 100 mg/die) or DAPT (acetylsalicylic acid 100 mg/die + ticagrelor 90 mg bis in die). DAPT will be continued for 12 months, and ticagrelor will be withdrawn thereafter. Primary endpoint is the evaluation of cardiac-related mortality at 5 years from hospital discharge.
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
- •patients undergoing CABG, ± cardiopulmonary bypass, ± any associated cardiac procedures (valve replacement,...)
- •incomplete myocardial revascularization, defined by anatomic or functional criteria
- •obtained informed consent
排除标准
- •acute coronary syndrome < 12 months from surgery
- •dual antiplatelet therapy at hospital admission
- •planned procedure to complete myocardial revascularization (e.g. hybrid approach)
- •intolerance / unable to take acetylsalicylic acid or ticagrelor
- •preoperative atrial fibrillation
- •impaired compliance
- •planned pregnancy
- •history of gastrointestinal bleeding
- •chronic kidney disease (eGFR < 30 mL/min/1.73 m2)
- •chronic liver disease
- •severe heart failure at hospital admission
- •active malignancy
- •alcohol abuse
- •any clinical condition not compatible with the treatment
- •Exit Criteria:
- •postoperative atrial fibrillation requiring anticoagulation
- •postoperative hemorrhagic events (stroke, GI bleeding)
- •occurrence of contraindications to acetylsalicylic acid or ticagrelor
- •surgical treatment requiring DAPT withdrawn
- •patient decision
研究组 & 干预措施
DAPT
"Dual antiplatelet therapy": acetylsalicylic acid 100 mg/die + ticagrelor 90 mg bis in die
干预措施: Ticagrelor (Drug)
DAPT
"Dual antiplatelet therapy": acetylsalicylic acid 100 mg/die + ticagrelor 90 mg bis in die
干预措施: acetylsalicylic acid (Drug)
SAPT
"Single antiplatelet therapy": acetylsalicylic acid 100 mg/die
干预措施: acetylsalicylic acid (Drug)
结局指标
主要结局
Cardiac-related mortality
时间窗: 5 years
次要结局
- Major adverse hemorrhagic events (MAHEs)(5 years)
- Mortality(5 years)
- Major adverse cardiac and cerebrovascular events (MACCEs)(5 years)
研究者
Antonio Nenna, MD
Cardiovascular Surgery
Campus Bio-Medico University