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临床试验/NCT04431349
NCT04431349已完成不适用

Comparison of Coronary Artery Bypass Graft Surgery Related Bleeding Complications in Patients Treated With Ticagrelor or Clopidogrel

Ajou University School of Medicine1 个研究点 分布在 1 个国家目标入组 1,097 人开始时间: 2016年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,097
试验地点
1
主要终点
Major bleeding event

研究概览

简要总结

In patients with coronary artery disease, dual antiplatelet therapy (acetylsalicylic acid and a P2Y12-receptor antagonist) is a commonly used method because of its excellent antithrombotic effect. In particular, in patients with acute myocardial infarction, who receive coronary angiography as an emergency, the dual antiplatelet is used immediately before the test to prevent and test further clot formation, regardless of whether or not the patient had previously taken dual antiplatelet.

Ticagrelor, a direct-acting and reversible ADP receptor antagonist, was introduced in Denmark in 2013 and is now the most commonly used ADP receptor antagonist in the treatment of ACS. Compared to its predecessor clopidogrel, the pharmacokinetic profil of ticagrelor is more predictable, demonstrating a faster onset of action and a more consistent platelet inhibition. However, because of the excellent antithrombotic effect and increased bleeding potential, it is recommended that major bleeding, such as OPCAB or CABG surgery, be expected with a high probability, and in case of fatal surgery, the drug should be discontinued for 5 days.

Most patients who receive emergency coronary heart surgery after undergoing coronary angiography as an emergency due to an acute myocardial infarction, it take approximately 24-48 hours to undergo surgery after examination. In fact, there have been reports of large-scale cross-country studies that do not increase bleeding risk compared to 5 days until 3 days after ticagrelor is stopped. Therefore, this study aimed to retrospectively analyze the bleeding tendency by analyzing the records of patients using clopidogrel or ticagrelor in preoperative coronary angiography for patients undergoing emergency CABG surgery from 2016 to September 2019.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • The patient with acute myocardial infarction received loading dose of clopidogrel or ticagrelor for coronary angiography within 2 days prior to emergency OPCAB or CABG.

排除标准

  • heart surgery combined with other operation (valve surgery, aorta surgery, trauma surgery)
  • History of coagulopathy
  • History of liver cirrhosis

研究组 & 干预措施

ticagrelor

The patient with acute myocardial infarction received loading dose of ticagrelor for coronary angiography within 2 days prior to OPCAB or CABG.

干预措施: Ticagrelor 180mg (Drug)

clopidogrel

The patient with acute myocardial infarction received loading dose of clopidogrel for coronary angiography within 2 days prior to OPCAB or CABG.

干预措施: Clopidogrel 75mg (Drug)

结局指标

主要结局

Major bleeding event

时间窗: within 48hours after operation

major bleeding defined as BARC-CABG related bleeding

次要结局

  • RBC transfusion amount(through study completion, an average of 1 month)

研究者

发起方
Ajou University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jiyoung Yoo

Assistant professor

Ajou University School of Medicine

研究点 (1)

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