跳至主要内容
临床试验/NCT02184884
NCT02184884已完成不适用

Effect of Perioperative Clopidogrel Responsiveness on Ischemic Outcome in Patients With Acute Coronary Syndrome Undergoing Off-pump Coronary Artery Bypass Surgery

Yonsei University1 个研究点 分布在 1 个国家目标入组 195 人开始时间: 2014年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
195
试验地点
1
主要终点
Rate of the major adverse cardiac events

研究概览

简要总结

The whole blood Thrombelastograph (TEG®) Platelet Mapping™ assay measures clot strength, maximal amplitude (MA), reflecting maximal platelet function, and detects the reduction in platelet function, presented as percentage inhibition, by both aspirin and clopidogrel. A study reported that the TEG® can be used as routine monitoring of the variability in ADP receptor inhibition and of antiplatelet therapy. Therefore, using TEG Platelet Mapping assay, we could find out the perioperative clopidogrel responsiveness of the patients with ACS undergoing OPCAB.

The purpose of this study is to determine whether the rate of the major adverse cardiac events (MACE, a combined endpoint of MI, revascularization and cardiac death) is higher in the patients with high degree of clopidogrel resistance, who are scheduled to undergo the OPCAB due to ACS.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • the patients with ACS undergoing OPCAB
  • the patients over 20 years of age
  • the patient who have been taking [100 mg of Aspirin] and [75 mg of clopidogrel or 180 mg of ticagrelor] for more than one week and who continue within 3 to 5 days prior to surgery

排除标准

  • re-operation or emergency operation
  • the patients with bleeding tendency of decreased liver function
  • Left ventricular ejection fraction < 40% by echo
  • preoperative hematocrit < 33% or platelet count < 100,000/mm3 or creatinine > 1.4 mg/dL
  • abnormal preoperative prothrombin time or activated partial thromboplastin time
  • preoperative use of other PO antiplatelet drugs or PO anticoagulants

结局指标

主要结局

Rate of the major adverse cardiac events

时间窗: at 30 days after surgery

major adverse cardiac events(MACE) includes the MI, revascularization and cardiac death. Rate of the MACE will be higher in the patients with high degree of clopidogrel resistance.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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