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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PPI group | Patients receiving PPI concomitant with dual antiplatelet therapy after PCI for AMI |
| |
| no PPI group | Patients receiving dual antiplatelet therapy only after PCI for AMI |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PPI | Drug | use of PPI concomitant with DAPT |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Rates of Major GI bleeding requiring transfusion | Efficacy outcome | 1-year follow-up |
| Rates of Major adverse cardiac event | Safety outcome, a composite of cardiac death, MI, ischemic stroke, and repeat revascularization | 1-year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of Major or Minor GI bleeding with hospitalization | Efficacy outcome | 1-year follow-up |
| Rates of Cardiac death | Cardiac death | 1-year follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with AMI undergoing PCI
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ki Hong Choi, MD | Contact | 82-2-3410-3419 | cardiokh@gmail.com | |
| Danbee Kang, PhD | Contact | 82-2-2148-7197 | dbee.kang@skku.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ki Hong Choi, MD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39962947 | Derived | Kang D, Choi KH, Park H, Heo J, Park TK, Lee JM, Cho J, Yang JH, Song YB, Choi SH, Gwon HC, Hahn JY. Effects of proton pump inhibitors on gastrointestinal bleeding and cardiovascular outcomes in myocardial infarction patients treated with DAPT. EuroIntervention. 2025 Feb 17;21(4):e229-e239. doi: 10.4244/EIJ-D-24-00673. |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Rates of Spontaneous MI | Spontaneous MI | 1-year follow-up |
| Rates of Ischemic stroke | Ischemic stroke | 1-year follow-up |
| Rates of Repeat revascularization | Repeat revascularization | 1-year follow-up |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |