Dual Antiplatelet Therapy in Patients With Clopidogrel Resistance Following Off-Pump Coronary Artery Bypass: Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Early graft patency
研究概览
简要总结
Ticagrelor, a direct-acting oral P2Y12-receptor antagonist, provides greater and more consistent platelet inhibition than clopidogrel. This study aimed to compare outcomes of ticagrelor plus aspirin versus clopidogrel plus aspirin 1 year after off-pump coronary artery bypass grafting (OPCAB) in patients with clopidogrel resistance.
详细描述
Between November 2014 and November 2020, 1739 patients underwent OPCAB. Aspirin (100mg daily) and clopidogrel (75mg daily) were administered beginning at aday 1 after surgery. On the 7th postoperative day, the clopidogrel resistance was evaluated by point-of-care assay. Among them, the patients had clopidogrel resistance were enrolled in this study. Investigators divide them into two groups [A: ticagrelor, B; clopidogrel]. Primary endpoint was all-cause of mortality 1 year after OPCAB. Secondary endpoint included major adverse cardiovascular events (MACE: cardiac death, myocardial infarction, or stroke). Multivariate Cox regression was used to evaluate predictors of end points.
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
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged 19 years or older
- •undergoing elective OPCAB surgery with multi-vessel coronary artery disease.
排除标准
- •patient had aspirin resistance
研究组 & 干预措施
Ticagrelor
干预措施: Ticagrelor (Drug)
Clopidogrel
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Early graft patency
时间窗: 1 year after OPCAB
graft occlusion rate diagnosed by CT exam, at follow-up angiography, grafts were evaluated by use of the usual definition of patency and were assessed for FitzGibbon patency with the A, B, and O classification system in which FitzGibbon A is an excellent/unimpaired graft, Bis an impaired graft with a stenosis \>50% reducing the caliber of the graft to \<50% of the target artery diameter, and O is a completely occluded graft.
次要结局
- degree of resistance(7 day after surgery)
- Number of patients with resistance with clopidogrel as assessed by VeriofyNowP2Y12 assay(7 day after surgery)
- Mediastinal Bleeding(up to 4 weeks)
- Total hospital day from admission to discharge(up to 4 weeks)
- rate of postoperative stroke of myocardial infarction(Participants will be followed during 1 years from operation)
- rate of postoperative morbidity/ mortality(Participants will be followed during 5 years from operation)