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.
This study aims to evaluate the impact of zastaprazan on platelet reactivity when co-administered with clopidogrel and to identify differences in potential drug-drug interactions compared to conventional Proton Pump Inhibitors (PPIs). Through this, we intend to propose an optimal combination strategy that simultaneously addresses antiplatelet efficacy and gastrointestinal protection. Notably, as rabeprazole is known to have a lower degree of CYP2C19 inhibition among PPIs, this study will specifically compare zastaprazan with rabeprazole to evaluate and confirm the comparative effects on platelet reactivity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
Participants will receive Zastaprazan \[20 mg\] orally once daily for \[6 month\] in addition to standard dual antiplatelet therapy (DAPT) including clopidogrel (75 mg/day).
Participants will receive Rabeprazole \[10 mg\] orally once daily for \[6month\] in addition to standard dual antiplatelet therapy (DAPT) including clopidogrel (75 mg/day).
Yongin Severance Hospital, Yonsei University
Yongin-si, Gyeonggi-do, South Korea
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
Time frame: 1 month
Change in Platelet Reactivity
Change in Platelet Reactivity
Time frame: 1 month, 3 months, and 6 months
Proportion of Participants Achieving Platelet Reactivity Within the Therapeutic Range
Change in Platelet Reactivity
Time frame: 1 month
Incidence of Major Adverse Cardiovascular Events (MACE)
Composite of cardiovascular death, myocardial infarction, or stroke.
Time frame: 6 month
Incidence of Individual Components of Major Adverse Cardiovascular Events (MACE)
Cardiovascular death, myocardial infarction, and stroke evaluated separately.
Time frame: 6 month
Incidence of Coronary Revascularization
Incidence of Coronary Revascularization
Time frame: 6 month
All-cause Mortality
All-cause Mortality
Time frame: 6 month
Incidence of Upper Gastrointestinal (GI) Bleeding
Incidence of Upper Gastrointestinal (GI) Bleeding
Time frame: 6 month
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Incidence of Bleeding Events According to BARC Criteria (Types 2, 3, or 5)
Incidence of Bleeding Events According to BARC Criteria (Types 2, 3, or 5)
Time frame: 6 month
Incidence of Adverse Drug Reactions (ADRs)
Incidence of Adverse Drug Reactions (ADRs)
Time frame: 6 month