Coronary Artery Disease
Conditions
Keywords
percutaeneous coronary intervention, dual antiplatelet therapy, gastrointestinal protection
Brief summary
Despite the fact that potassium competitive acid blocker (P-CAB) has been developed for the treatment of gastric ulcer or gastroesophageal reflux disease, the efficacy and safety of P-CAB for the use of gastrointestinal (GI) protection in patients undergoing percutaneous coronary intervention (PCI) and maintaining dual antiplatelet therapy (DAPT) remains uncertain.
Detailed description
To evaluate the efficacy and safety of routine P-CAB use in patients with coronary artery disease who underwent PCI and maintain DAPT, as compared to guideline-directed proton pump inhibitor (PPI) usage.
Interventions
This group received P-CAB with DAPT after PCI.
This group received PPI or not with DAPT after PCI according to GI bleeding risk.
Sponsors
Study design
Eligibility
Inclusion criteria
* Patients who underwent PCI * Use of either clopidogrel, prasugrel, or ticagrelor in combination with aspirin * No use of PCAB, PPI, or an H2-receptor within the past month
Exclusion criteria
* Patients with low GI bleeding risk are taken on PPI * Patients with high GI bleeding risk do not take PPI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major GI bleeding | at 1 year | Major GI bleeding requiring transfusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinically relevant GI bleeding | At 1 year | Clinically relevant GI bleeding |
| Major adverse cardiac event | At 1 year | A composite of cardiovascular death, myocardial infarction, and repeat revascularization |
| Cardiovascular death | At 1 year | Cardiovascular death |
| Myocardial infarction | At 1 year | Myocardial infarction |
| Repeat revascularization | At 1 year | Repeat revascularization |
Countries
South Korea