Routine use of Potassium Competitive Acid Blocker vs guideline GI protection in AMI with PCI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label, randomized Phase 3 trial enrolling 5,000 AMI patients undergoing PCI who are on dual antiplatelet therapy. Participants are assigned 1:1 to either routine use of a potassium competitive acid blocker (P-CAB) or to a guideline-directed GI protection strategy, with Zastaprazan or a proton pump inhibitor as the investigated agents. The primary endpoint is Net Adverse Clinical Events (NACE), a composite of death, MI, stroke, or BARC 3-5 bleeding at 1 year. The study aims to determine which GI protection approach yields better overall cardiovascular and bleeding outcomes in this high-risk population. Data will be collected across multiple centers with standardized follow-up.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients aged 19 years or older.
* Patients diagnosed with acute myocardial infarction (ST-segment elevation myocardial infarction \[STEMI\] or non-ST-segment elevation myocardial infarction \[NSTEMI\]).
* Patients who underwent percutaneous coronary intervention (PCI) with drug-eluting stents (DES) or drug-coated balloons (DCB).
* Patients (or their legal representatives) who understood the study risks and benefits and provided voluntary written informed consent.

Exclusion Criteria:

* History of hypersensitivity (e.g., allergic reaction, anaphylactic shock) or contraindication to study drugs (potassium-competitive acid blocker \[P-CAB\] or proton pump inhibitor \[PPI\]).
* Presence of active gastrointestinal bleeding.
* Pregnant or breastfeeding women.
* Non-cardiac life expectancy of less than 1 year or patients expected to have low compliance (as determined by the investigator's medical judgment).
* Patients who refuse to participate or are unable to follow the requirements specified in the study protocol.

Where it's running

• Samsung Medical center
  Seoul, South Korea Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.