Impact of Hybrid Coronary Revascularization on Antiplatelet Effect of Aspirin and Clopidogrel
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in aspirin antiplatelet effect from preoperative to three days postoperative
研究概览
简要总结
The effect of antiplatelet therapy is impaired among patients, who recently underwent on-pump coronary artery bypass grafting. The impact of hybrid coronary revascularization using minimal invasive surgical techniques on the antiplatelet effect of aspirin and clopidogrel remains unclear.
The aim of the study is to describe the impact of hybrid coronary revascularization on the effect of aspirin and clopidogrel. Furthermore, we will investigate whether high baseline platelet aggregation, high postoperative levels of platelet turnover and acute-phase response may contribute to the effect.
详细描述
Objective:
The effect of antiplatelet therapy is impaired among patients, who recently underwent on-pump coronary artery bypass grafting. The impact of hybrid coronary revascularization using minimal invasive surgical techniques on the antiplatelet effect of aspirin and clopidogrel remains unclear.
We hypothesize that hybrid coronary revascularization is associated with a transiently reduced antiplatelet effect of aspirin and clopidogrel. We hypothesize that the reduced antiplatelet effect of aspirin and clopidogrel could be explained by increased platelet turnover with an increased fraction of immature platelets in the peripheral blood. Furthermore, we hypothesize that the reduced antiplatelet effect is associated with increased inflammatory markers in the early postoperative phase. We hypothesize, that high platelet aggregation prior to the intervention is associated with reduced effect of antiplatelet therapy following hybrid coronary revascularization.
Methods:
40 patients with coronary artery disease will be enrolled in this prospective cohort study (recruited from a prospective pilot study conducted to assess feasibility and safety of hybrid coronary revascularization combining minimally invasive off-pump coronary artery bypass grafting through an inferior J-hemisternotomy (JOPCAB) with percutaneous coronary intervention - Clinicaltrials.gov identifier: NCT01496664). Demographics and medical history are documented preoperatively. The predicted mortality is assessed by means of the logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) I. Adverse cardiovascular events are recorded prospectively, including graft dysfunction, myocardial infarction, stroke, and pulmonary embolism.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •symptomatic multivessel coronary artery disease
- •treatment with non-enteric coated aspirin 75 mg once daily
排除标准
- •aspirin or clopidogrel intolerance
- •conditions prohibitive of aspirin discontinuation prior to surgery
- •use of anticoagulants or any drugs other than aspirin known to affect platelet function
- •use of immunosuppressive drugs
- •platelet count <100 or >450 x 109/l
- •inability to give informed consent
结局指标
主要结局
Change in aspirin antiplatelet effect from preoperative to three days postoperative
时间窗: 12-14 days
Platelet aggregation measured by VerifyNow® Aspirin and Multiplate® Analyzer
次要结局
- Change on clopidogrel antiplatelet effect from first day after PCI to 1 year follow-up(1 year)
- Correlation between platelet turnover and platelet aggregation(8-10 days preoperative until 1 year postoperative)
- Association between baseline platelet aggregation (off-aspirin) and aspirin antiplatelet effect(12-14 days)
- Change on aspirin antiplatelet effect from 3 days postoperative to 1 year follow-up(1 year)
- Correlation between acute phase reactants and platelet aggregation(8-10 days preoperative until 1 year postoperative)
研究者
Ivy Modrau
Junior Consultant
Aarhus University Hospital Skejby
