The purpose of this study is to evaluate the clinical utility of zastaprazan compared to proton pump inhibitors (PPIs) in patients receiving dual antiplatelet therapy (DAPT) including clopidogrel after percutaneous coronary intervention (PCI), by comparing their effects on platelet reactivity.
Age 19 years or older at the time of providing informed consent.
Patients with Chronic Coronary Syndrome (CCS) who have undergone Percutaneous Coronary Intervention (PCI) and agreed to participate in the study.
Patients who are required to maintain dual antiplatelet therapy (DAPT) including clopidogrel for at least 6 months after PCI.
Patients who have voluntarily provided written informed consent to participate in this clinical study.
History of hypersensitivity to P-CABs, PPIs, benzimidazoles, aspirin, clopidogrel, or any of the excipients in the study drugs.
History of or planned surgery that may affect gastric acid secretion, such as upper gastrointestinal resection, acid suppression surgery, or gastric mucosal resection. (However, patients who have undergone simple perforation repair of the stomach or duodenum, appendectomy, cholecystectomy, hysterectomy, or endoscopic/laparoscopic resection of benign tumors are eligible).
Diagnosis of Zollinger-Ellison syndrome or inflammatory diseases (e.g., pancreatitis, or inflammatory bowel diseases such as Crohn's disease or ulcerative colitis).
Currently receiving HIV protease inhibitors (atazanavir, nelfinavir) or rilpivirine-containing products.
Parallel
Zastaprazan
DrugParticipants will receive Zastaprazan \[20 mg\] orally once daily for \[6 month\] in addition to standard dual antiplatelet therapy (DAPT) including clopidogrel (75 mg/day).
Rabeprazole
DrugParticipants will receive Rabeprazole \[10 mg\] orally once daily for \[6month\] in addition to standard dual antiplatelet therapy (DAPT) including clopidogrel (75 mg/day).
Assessment of platelet reactivity using P2Y12 Reaction Units (PRU) by the VerifyNow assay at 1 month
Assessment of platelet reactivity using P2Y12 Reaction Units (PRU) by the VerifyNow assay at 1 month
Change in Platelet Reactivity
Change in Platelet Reactivity
Proportion of Participants Achieving Platelet Reactivity Within the Therapeutic Range
Change in Platelet Reactivity
Incidence of Major Adverse Cardiovascular Events (MACE)
Composite of cardiovascular death, myocardial infarction, or stroke.
Incidence of Individual Components of Major Adverse Cardiovascular Events (MACE)
Cardiovascular death, myocardial infarction, and stroke evaluated separately.
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Yonsei University
Lead sponsor
Jeil Pharmaceutical Co., Ltd.
Collaborator
