An observational study in Myocardial Infarction and Coronary Artery Disease, sponsored by Samsung Medical Center. Recruiting at 1 site in Korea, Republic of. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-03-26.
Sponsored by Samsung Medical Center · Observational
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 118,420 is above the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with AMI undergoing PCI
Exclusion Criteria:
Patients receiving PPI concomitant with dual antiplatelet therapy after PCI for AMI
Drug: PPI
Patients receiving dual antiplatelet therapy only after PCI for AMI
use of PPI concomitant with DAPT
Also known as: GI protection
Rates 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
Plan to share: Undecided
No publications or documents are linked to this record.
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Samsung Medical Center