Trials / Not Yet Recruiting
Not Yet RecruitingNCT07467213
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
- Not Yet Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 5,000 (estimated)
- Sponsor
- Samsung Medical Center · Academic / Other
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2026-04-01
- Primary completion
- 2029-12-31
- Completion
- 2030-12-31
- First posted
- 2026-03-12
- Last updated
- 2026-03-12
Source: ClinicalTrials.gov record NCT07467213. Inclusion in this directory is not an endorsement.