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Routine Use of Potassium Competitive Acid Blocker vs. Guideline-Directed Gastrointestinal Protection Strategy in Acute Myocardial Infarction

NCT07467213

RecruitingPhase 3

Sponsor: Samsung Medical Center

Conditions: Acute Myocardial Infarction (AMI), Gastrointestinal Bleeding

Interventions: Zastaprazan, Proton Pump Inhibitors (PPI)

Countries: South Korea

This study aims to compare the clinical outcomes between routine use of potassium competitive acid blocker (P-CAB) and guideline-directed gastrointestinal (GI) protection strategy in patients with acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI) and being treated with dual antiplatelet therapy (DAPT).

Eligibility overview

Sex: ALL

Age: 19 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Seoul, South Korea