ThrombElastoGraphic Haemostatic Status and Antiplatelet Therapy After Coronary Artery Bypass Graft Surgery(TEG-CABG Trial):Does Intensified Postoperative Antiplatelet Therapy in Preoperatively Identified Hypercoagulable Patients Improve Outcome After CABG Surgery
试验速览
- 阶段
- 3 期
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Graft patency at 3 months
研究概览
简要总结
The purpose of this study is to determine whether adding clopidogrel to aspirin after coronary bypass operation (CABG) improves graft patency, in patients that have preoperatively increased platelet activity(hypercoagulable) and therefore greater risk of graft occlusion( thrombosis).
详细描述
Graft patency after CABG is reported to 80-90% worldwide 1 year following surgery. In the immediate period after surgery, and the following month, graft occlusion mainly occurs due to thrombosis.
Patients with platelet hyperreactivity have increased risk of thromboembolic events, including graft occlusion, myocardial infarction and stroke. Therefore intensifying the antiplatelet therapy in these patients, must be anticipated to have beneficial effects.
Hypercoagulable patients are identified with thrombelastography(TEG) as having a Maximal Amplitude(MA)>69, thereafter randomized to either clopidogrel(3months) and aspirin or aspirin alone. At 3 months postoperative after surgery the coronary graft patency is assessed with Multislice CT scan.
Pre- and postoperatively, and then again at 3month followup, TEG and multiplate aggregometry are performed to assess platelet reactivity and resistance to aspirin and clopidogrel.
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
- •Elective/subacute multivessel CABG
- •Isolated CABG procedure, no concomitant surgery
- •age > 18 years
- •Able to give informed consent
排除标准
- •Myocardial infarction <48h of surgery
- •Prior CABG surgery within 1 month
- •Cardiac Shock within 48h of surgery
- •Atrial fibrillation
- •Anticoagulation therapy with VKA
- •ICH/TCI within 30 days
- •Prior peptic ulcer· Platelet count < 150 E9
- •Ongoing bleeding
- •Known platelet disease
- •Allergic to aspirin or clopidogrel
- •Liver disease with elevated ALAT/ASAT> 1,5x normal
- •Creatinine> 0,120mmol/l
- •Contrast allergy
- •Alcohol or narcotics abuse
- •Pregnancy
- •Not able to give informed consent
- •Geographically not available for follow up
研究组 & 干预措施
Clopidogrel+Aspirin, hypercoagulabel
干预措施: Clopidogrel+acetylsalicylic acid (Drug)
Aspirin,hypercoagulabel control
干预措施: acetylsalicylic acid (Drug)
结局指标
主要结局
Graft patency at 3 months
时间窗: 3 months
Graft patency of Saphenous vein grafts will be significantly higher in TEG-Hypercoagulable patients on clopidogrel+aspirin vs. aspirin alone.
次要结局
- Rate of other thromboembolic events( e.g. myocardial infarction,stroke, pulmonary embolus etc.)and cardiovascular death(3 months)
- Assessing coagulation profile pre- and postoperatively, including aspirin and clopidogrel resistance(3 months)
研究者
Sulman Rafiq
MD
Rigshospitalet, Denmark