Impact of Potassium Competitive Acid Blockers After Percutaneous Coronary Intervention for Efficacy and Safety Outcome: Target Trial Emulation Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100,000
- 试验地点
- 1
- 主要终点
- Major GI bleeding
研究概览
简要总结
Despite the fact that potassium competitive acid blocker (P-CAB) has been developed for the treatment of gastric ulcer or gastroesophageal reflux disease, the efficacy and safety of P-CAB for the use of gastrointestinal (GI) protection in patients undergoing percutaneous coronary intervention (PCI) and maintaining dual antiplatelet therapy (DAPT) remains uncertain.
详细描述
To evaluate the efficacy and safety of routine P-CAB use in patients with coronary artery disease who underwent PCI and maintain DAPT, as compared to guideline-directed proton pump inhibitor (PPI) usage.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who underwent PCI
- •Use of either clopidogrel, prasugrel, or ticagrelor in combination with aspirin
- •No use of PCAB, PPI, or an H2-receptor within the past month
排除标准
- •Patients with low GI bleeding risk are taken on PPI
- •Patients with high GI bleeding risk do not take PPI
研究组 & 干预措施
Routine use of P-CAB
All-comer patients with P-CAB
干预措施: Routine use of P-CAB on DAPT (Drug)
Guideline-directed GI protection strategy
Use of PPI or not according to GI bleeding risk
干预措施: Guideline Directed Medical Therapy (Drug)
结局指标
主要结局
Major GI bleeding
时间窗: at 1 year
Major GI bleeding requiring transfusion
次要结局
- Clinically relevant GI bleeding(At 1 year)
- Cardiovascular death(At 1 year)
- Myocardial infarction(At 1 year)
- Major adverse cardiac event(At 1 year)
- Repeat revascularization(At 1 year)
研究者
Ki Hong Choi
Associate Professor
Samsung Medical Center