Effects of PPI on GI Bleeding and Cardiovascular Outcomes Among Post-MI Patients Taking DAPT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 118,420
- 试验地点
- 1
- 主要终点
- Rates of Major adverse cardiac event
研究概览
简要总结
Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
详细描述
This is a non-randomized, non-interventional study from Korean National Health Insurance Service database. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- PCI with MI (I21) admission
- •Age more than 40 or less than 80 years old
- •Aspirin and Clopidogrel/Prasugrel/Ticagrelor prescription with more than 2 days at discharge
排除标准
- •- Previous use of a PPI, an H2-receptor antagonist, sucralfate, or misoprostol within 30 days before admission
- •Preexisting cancer within a year before admission
- •History of RBC transfusion
- •RBC transfusion in admission
- •Cardiogenic Shock
- •Length of stay more than 14 days
- •OAC prescription with more than 2 days at discharge
- •H2 prescription with more than 2 days at discharge
研究组 & 干预措施
PPI group
Patients receiving PPI concomitant with dual antiplatelet therapy after PCI for AMI
干预措施: PPI (Drug)
结局指标
主要结局
Rates of Major adverse cardiac event
时间窗: 1-year follow-up
Safety outcome, a composite of cardiac death, MI, ischemic stroke, and repeat revascularization
Rates of Major GI bleeding requiring transfusion
时间窗: 1-year follow-up
Efficacy outcome
次要结局
- Rates of Major or Minor GI bleeding with hospitalization(1-year follow-up)
- Rates of Cardiac death(1-year follow-up)
- Rates of Spontaneous MI(1-year follow-up)
- Rates of Ischemic stroke(1-year follow-up)
- Rates of Repeat revascularization(1-year follow-up)
研究者
Ki Hong Choi
Professor
Samsung Medical Center