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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Routine Potassium Competitive Acid Blocker Group | Experimental |
| |
| Guideline-Directed Gastrointestinal Protection Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zastaprazan | Drug | Zastaprazan citrate 20mg will be administered orally once daily for gastrointestinal protection according to the study protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Net Adverse Clinical Events (NACE) | A composite of death from any causes, myocardial infarction, stroke, or Bleeding Academic Research Consortium (BARC) type 2, 3-5 bleeding. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical center | Recruiting | Seoul | 06351 | South Korea |
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| Proton Pump Inhibitors (PPI) | Drug | Guideline-directed gastrointestinal protection using various proton pump inhibitors as determined by the physician. |
|
| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D054328 | Proton Pump Inhibitors |
| ID | Term |
|---|---|
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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