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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5,000
Zastaprazan citrate 20mg will be administered orally once daily for gastrointestinal protection according to the study protocol.
Guideline-directed gastrointestinal protection using various proton pump inhibitors as determined by the physician.
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.
Time frame: 1 year
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