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

NCT07467213 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: SMC 2025-09-069-006
• Study Type: interventional
• Target: 5,000
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Acute Myocardial Infarction (AMI); Gastrointestinal Bleeding

Keywords

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

Outcome Measures

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 3-5 bleeding.

  1 year

Study Arms (2)

Routine Potassium Competitive Acid Blocker Group

EXPERIMENTAL

Drug: Zastaprazan

Guideline-Directed Gastrointestinal Protection Group

ACTIVE COMPARATOR

Drug: Proton Pump Inhibitors (PPI)

Interventions

Zastaprazan DRUG

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

Routine Potassium Competitive Acid Blocker Group

Proton Pump Inhibitors (PPI) DRUG

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

Guideline-Directed Gastrointestinal Protection Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samsung Medical Center: lead

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

Proton Pump Inhibitors

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 12, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: March 12, 2026

Record last verified: 2026-03