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.
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.
Study Type
OBSERVATIONAL
Enrollment
118,420
use of PPI concomitant with DAPT
Samsung Medical Center
Seoul, South Korea
RECRUITINGRates of Major GI bleeding requiring transfusion
Efficacy outcome
Time frame: 1-year follow-up
Rates of Major adverse cardiac event
Safety outcome, a composite of cardiac death, MI, ischemic stroke, and repeat revascularization
Time frame: 1-year follow-up
Rates of Major or Minor GI bleeding with hospitalization
Efficacy outcome
Time frame: 1-year follow-up
Rates of Cardiac death
Cardiac death
Time frame: 1-year follow-up
Rates of Spontaneous MI
Spontaneous MI
Time frame: 1-year follow-up
Rates of Ischemic stroke
Ischemic stroke
Time frame: 1-year follow-up
Rates of Repeat revascularization
Repeat revascularization
Time frame: 1-year follow-up
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.