Myocardial Infarction, Coronary Artery Disease
Conditions
Keywords
Percutaneous coronary intervention, Cardiovascular Pharmacotherapy, Proton pump inhibitor, Dual antiplatelet therapy
Brief summary
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.
Detailed description
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.
Interventions
DRUGPPI
use of PPI concomitant with DAPT
Sponsors
Samsung Medical Center
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* \- 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
Exclusion criteria
* \- 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rates of Major GI bleeding requiring transfusion | 1-year follow-up | Efficacy outcome |
| Rates of Major adverse cardiac event | 1-year follow-up | Safety outcome, a composite of cardiac death, MI, ischemic stroke, and repeat revascularization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rates of Spontaneous MI | 1-year follow-up | Spontaneous MI |
| Rates of Major or Minor GI bleeding with hospitalization | 1-year follow-up | Efficacy outcome |
| Rates of Repeat revascularization | 1-year follow-up | Repeat revascularization |
| Rates of Ischemic stroke | 1-year follow-up | Ischemic stroke |
| Rates of Cardiac death | 1-year follow-up | Cardiac death |
Countries
South Korea
Contacts
Primary ContactKi Hong Choi, MD
Backup ContactDanbee Kang, PhD
Outcome results
None listed