Clopidogrel or Ticagrelor in Acute Coronary Syndrome Patients Treated With Newer-Generation Drug-Eluting Stents: CHANGE DAPT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,062
- 试验地点
- 1
- 主要终点
- Net adverse clinical and cerebral events (NACCE)
研究概览
简要总结
Acute coronary syndrome (ACS) guidelines have been changed, favoring dual antiplatelet therapy (DAPT) with the more potent P2Y12 inhibitor ticagrelor over clopidogrel (besides aspirin). This change is based on studies that showed benefits of ticagrelor. However, study participants were only partly treated by percutaneous coronary intervention (PCI). In patients who were treated by PCI, this was generally performed using of bare metal or first-generation drug-eluting stents (DES).
CHANGE DAPT is an investigator-initiated, prospective, single centre registry, in which we evaluate the impact of the guideline suggested change in the primary DAPT regimen (from clopidogrel to ticagrelor) on 1-year clinical outcome in ACS patients treated by PCI with newer-generation DES in the Thoraxcentrum Twente.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Presentation with acute coronary syndrome (ACS)
- •Treated with newer-generation drug-eluting stent (DES) in coronary artery or bypass graft lesion
排除标准
- •Known pregnancy
- •Life expectancy less than one year
- •Planned elective surgery requiring interruption of DAPT in the first 6 months
- •Known intolerance to components of the DES available
- •Indication for oral anticoagulation at baseline
研究组 & 干预措施
Clopidogrel Period
ACS patients treated by PCI with newer-generation DES before the guideline suggested change in primary DAPT-regimen
干预措施: Clopidogrel (Drug)
Ticagrelor Period
ACS patients treated by PCI with newer-generation DES after the guideline suggested change in primary DAPT-regimen
干预措施: Ticagrelor (Drug)
结局指标
主要结局
Net adverse clinical and cerebral events (NACCE)
时间窗: 1 year
A composite of all-cause death, any myocardial infarction, stroke, or major bleeding.
次要结局
- Any myocardial infarction(1 year)
- All-cause death(1 year)
- Stent thrombosis(1 year)
- Stroke(1 year)
- Any clinically indicated revascularization(1 year)
- Major Bleeding(1 year)