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

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07467213

Acronym

PCAB-AMI

Enrollment

5000

Registered

2026-03-12

Start date

2026-06-23

Completion date

2030-12-31

Last updated

2026-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction (AMI), Gastrointestinal Bleeding

Keywords

Percutaneous Coronary Intervention, Dual Antiplatelet Therapy, Potassium Competitive Acid Blocker, Zastaprazan

Brief summary

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

DRUGZastaprazan

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

DRUGProton Pump Inhibitors (PPI)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Net Adverse Clinical Events (NACE)	1 year	A composite of death from any causes, myocardial infarction, stroke, or Bleeding Academic Research Consortium (BARC) type 2, 3-5 bleeding.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 27, 2026