Menu
Recruiting NCT07467213

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

Phase III Interventional Acute Myocardial Infarction (AMI) Gastrointestinal Bleeding

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: Zastaprazan, Proton Pump Inhibitors (PPI).
Who it may be relevant to
Registry conditions: Acute Myocardial Infarction (AMI), Gastrointestinal Bleeding. Basic parameters: from 19 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 →

Unsure about the terms? Read our patient guide →

Official title

Routine Use of Potassium Competitive Acid Blocker Versus Guideline-Directed Gastrointestinal Protection Strategy in Patients With Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention on Dual Antiplatelet Therapy: A Randomized Trial

Overview

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).

Detailed description

This is a prospective, open-label, two-arm, randomized, multi-center trial. A total of 5,000 patients with acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI) and receiving dual antiplatelet therapy (DAPT) will be enrolled and randomized in a 1:1 ratio. Patients will be assigned to either the routine use of P-CAB group or the guideline-directed GI protection strategy group. The primary endpoint is the occurrence of Net Adverse Clinical Events (NACE), a composite of death from any causes, myocardial infarction, stroke, or Bleeding Academic Research Consortium (BARC) type 3-5 bleeding at 1 year.

Interventions

  • Drug Zastaprazan
    Zastaprazan citrate 20mg will be administered orally once daily for gastrointestinal protection according to the study protocol.
  • Drug Proton Pump Inhibitors (PPI)
    Guideline-directed gastrointestinal protection using various proton pump inhibitors as determined by the physician.

Primary outcome measures

  • Net Adverse Clinical Events (NACE) [Time frame: 1 year]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Samsung Medical center — Seoul

Identifiers

NCT: NCT07467213 · SMC 2025-09-069-006

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗