Impact of Potassium Competitive Acid Blockers After Percutaneous Coronary Intervention for Efficacy and Safety Outcome: Target Trial Emulation Study.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Routine use of P-CAB on DAPT, Guideline Directed Medical Therapy.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Drug Routine use of P-CAB on DAPT
This group received P-CAB with DAPT after PCI. - Drug Guideline Directed Medical Therapy
This group received PPI or not with DAPT after PCI according to GI bleeding risk.
Primary outcome measures
- Major GI bleeding [Time frame: at 1 year]
Secondary outcome measures (5)
- Clinically relevant GI bleeding [Time frame: At 1 year]
- Major adverse cardiac event [Time frame: At 1 year]
- Cardiovascular death [Time frame: At 1 year]
- Myocardial infarction [Time frame: At 1 year]
- Repeat revascularization [Time frame: At 1 year]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Samsung Medical Center — Seoul
Identifiers
NCT: NCT07068490 · PCAB_TTE