HOST-EXAM-Ex : Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis - EXtended Antiplatelet Monotherapy - EXtended Follow up
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 5,530
- 主要终点
- Patient oriented composite outcome
研究概览
简要总结
This is an retrospective extended study of a randomized clinical trial (The HOST-EXAM trial ClinicalTrials.gov Identifier: NCT02044250).
Investigators will perform a retrospective analysis of all participants enrolled in this trial will be performed, until the longest follow-up duration.
详细描述
The HOST-EXAM trial (ClinicalTrials.gov Identifier: NCT02044250) was an randomized clinical trial that was performed to compare head-to-head, the efficacy and safety between aspirin and clopidogrel monotherapy in patients who received PCI for coronary artery disease and required chronic maintenance antiplatelet therapy. From March 2014 through May 2018, a total of 5438 patients were enrolled, and follow-up was performed upto 24 months after randomization. After this study, randomization was unlocked and patients were followed-up based on the standard protocol.
Afterwards, the current study was planned to perform a extended follow-up of the HOST-EXAM population. The specific drug by the randomization group in the HOST-EXAM trial was not mandatory after the initial 24 months, therefore participants received medication according to the current guidelines, and according to the physicians preferences.
This is a observational, retrospective analysis of all clinical events after the randomization period. The prescribed medications and any clinical events will be evaluated.
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
- 否
入选标准
- •Patients who were enrolled in the HOST-EXAM randomized clinical trial
排除标准
- •None, otherwise the patient refuses to participate in this study, or refuses to provide personal medical information
研究组 & 干预措施
Clopidogrel group
This group are those who received clopidogrel 75mg qd as a single antiplatelet agent therapy after PCI.
干预措施: Antiplatelet Agents (Drug)
Aspirin group
This group are those who received aspirin 100mg qd as a single antiplatelet agent therapy after PCI.
干预措施: Antiplatelet Agents (Drug)
结局指标
主要结局
Patient oriented composite outcome
时间窗: From date of randomization until March, 2022.
A composite of all-cause death, nonfatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and major bleeding complication
次要结局
- Bleeding outcome(From date of randomization until March, 2022.)
- Thrombotic outcome(From date of randomization until March, 2022.)
研究者
Hyo-Soo Kim
Professor, Department of Internal Medicine
Seoul National University Hospital