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临床试验/NCT04999293
NCT04999293已完成不适用

Antiplatelet Therapy in Elderly Patients Undergoing Percutaneous Coronary Intervention

The First Affiliated Hospital of Dalian Medical University1 个研究点 分布在 1 个国家目标入组 1,505 人开始时间: 2021年7月20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
1,505
试验地点
1
主要终点
Types 2, 3, and 5 bleeding, as defined by the Bleeding Academic Research Consortium

研究概览

简要总结

The study is an investigator-sponsored, retrospective cohort study designed to compare efficacy and safety of ticagrelor in elderly patients undergoing percutaneous coronary intervention.

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
75 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age≥75 years old;
  • Treated with PCI (limited to stent implantation) ;
  • Survivors and treated with DAPT (aspirin [100 mg once daily], cilostazol, or indobufen)combined with a P2Y12 receptor antagonist [clopidogrel (75 mg once daily) or ticagrelor (90 mg twice daily)]) at discharge;

排除标准

  • Coronary artery bypass graft (CABG) or only drug conservative treatment during hospitalization;
  • Concurrent use of oral anticoagulants;
  • Inability to tolerate long-term antiplatelet therapy, such as active bleeding and a bleeding tendency;
  • Acute infectious diseases;
  • Cognitive impairment;
  • Declined re-examination.

研究组 & 干预措施

The Elderly Undergoing Percutaneous Coronary Intervention

Patients were survivors and treated with DAPT (aspirin [100 mg once daily], cilostazol, or indobufen)combined with a P2Y12 receptor antagonist [clopidogrel (75 mg once daily) or ticagrelor (90 mg twice daily)]) at the time of hospital discharge.All patients were followed for 1 year in the outpatient clinic after hospital discharge.

干预措施: Ticagrelor (Drug)

结局指标

主要结局

Types 2, 3, and 5 bleeding, as defined by the Bleeding Academic Research Consortium

时间窗: 12 months

The primary safety endpoint

Combined major adverse cardiovascular and cerebrovascular events (MACCEs), including all-cause mortality, myocardial infarction, ischemic stroke, and any revascularization.

时间窗: 12 months

The primary efficacy endpoint

次要结局

  • Incidence of major and minor bleeding defined by the TIMI study(12 months)
  • Revascularization(12 months)
  • Ischemic stroke(12 months)
  • Incidence of BARC3 and 5 bleeding(12 months)
  • Incidence of major and minor bleeding defined by the PLATO study(12 months)
  • All-cause mortality(12 months)
  • Myocardial infarction(12 months)
  • Occurrence of any bleeding(12 months)

研究者

发起方
The First Affiliated Hospital of Dalian Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Meng Shaoke

M.D.

The First Affiliated Hospital of Dalian Medical University

研究点 (1)

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