Using a potassium‑competitive acid blocker after PCI to protect the stomach.
Impact of Potassium Competitive Acid Blockers After Percutaneous Coronary Intervention for Efficacy and Safety Outcome: Target Trial Emulation Study.
We will see if giving a potassium‑competitive acid blocker instead of a proton pump inhibitor helps prevent stomach bleeding in people who had PCI and are taking dual antiplatelet medicines.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Samsung Medical Center Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT07068490 on ClinicalTrials.gov |
What this trial studies
This is an observational target‑trial emulation comparing routine use of potassium‑competitive acid blockers (P‑CABs) versus guideline‑directed proton pump inhibitor (PPI) use for gastrointestinal protection in patients who underwent percutaneous coronary intervention (PCI) and remain on dual antiplatelet therapy (DAPT). The study uses real‑world clinical data from Samsung Medical Center to compare efficacy (GI bleeding prevention) and safety (including cardiovascular events) between the two approaches. Researchers will apply statistical methods to emulate a randomized trial and adjust for confounding factors such as baseline bleeding risk and concomitant medications. Outcomes will include rates of GI bleeding, major adverse cardiovascular events, and other safety endpoints during follow‑up.
Who should consider this trial
Good fit: People who underwent PCI, are taking aspirin plus clopidogrel, prasugrel, or ticagrelor, and who have not used a P‑CAB, PPI, or H2 blocker in the past month are eligible.
Not a fit: Patients who are already prescribed a PPI because of their bleeding risk or those with high GI bleeding risk who are not taking a PPI (and thus were excluded) are unlikely to benefit from enrollment in this comparison.
Why it matters
Potential benefit: If successful, this approach could offer equal or better stomach protection for PCI patients on DAPT with comparable cardiovascular safety, potentially reducing GI bleeding and related hospital visits.
How similar studies have performed: Previous trials show P‑CABs provide stronger acid suppression than PPIs, but there is limited direct evidence on GI bleeding or cardiovascular outcomes in patients on DAPT, so this clinical application remains relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seoul
- Samsung Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: KI HONG CHOI, MD, PhD — Samsung Medical Center
- Study coordinator: Ki Hong Choi, MD, PhD
- Email: cardiokh@gmail.com
- Phone: 82-2-3410-3419
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.