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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age19+
SponsorSamsung Medical Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Zastaprazan

    Drug

    Zastaprazan citrate 20mg will be administered orally once daily for gastrointestinal protection according to the study protocol.

  • Proton Pump Inhibitors (PPI)

    Drug

    Guideline-directed gastrointestinal protection using various proton pump inhibitors as determined by the physician.

Treatment groups

5,000 Participants
are divided into 2 treatment groups
Group A: Routine Potassium Competitive Acid Blocker GroupExperimental treatment 1 intervention
Group B: Guideline-Directed Gastrointestinal Protection GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Net Adverse Clinical Events (NACE)

A composite of death from any causes, myocardial infarction, stroke, or Bleeding Academic Research Consortium (BARC) type 2, 3-5 bleeding.

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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