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

March 9, 2026 updated by: Samsung Medical Center

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

5000

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.
  • Patients with suspected gastroesophageal reflux disease (GERD).

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Routine Potassium Competitive Acid Blocker Group
Drug: Zastaprazan
Zastaprazan citrate 20mg will be administered orally once daily for gastrointestinal protection according to the study protocol.
Active Comparator: Guideline-Directed Gastrointestinal Protection Group
Drug: Proton Pump Inhibitors (PPI)
Guideline-directed gastrointestinal protection using various proton pump inhibitors as determined by the physician.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

March 9, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMC 2025-09-069-006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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