Chronic Coronary Syndrome
Conditions
Keywords
Chronic Coronary Syndrome, zastaprazan
Brief summary
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.
Detailed description
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.
Interventions
DRUGZastaprazan
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).
DRUGRabeprazole
Participants will receive Rabeprazole \[10 mg\] orally once daily for \[6month\] in addition to standard dual antiplatelet therapy (DAPT) including clopidogrel (75 mg/day).
Sponsors
Yonsei University
Jeil Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 19 years or older at the time of providing informed consent. 2. Patients with Chronic Coronary Syndrome (CCS) who have undergone Percutaneous Coronary Intervention (PCI) and agreed to participate in the study. 3. Patients who are required to maintain dual antiplatelet therapy (DAPT) including clopidogrel for at least 6 months after PCI. 4. Patients who have voluntarily provided written informed consent to participate in this clinical study.
Exclusion criteria
1. History of hypersensitivity to P-CABs, PPIs, benzimidazoles, aspirin, clopidogrel, or any of the excipients in the study drugs. 2. 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). 3. Diagnosis of Zollinger-Ellison syndrome or inflammatory diseases (e.g., pancreatitis, or inflammatory bowel diseases such as Crohn's disease or ulcerative colitis). 4. Currently receiving HIV protease inhibitors (atazanavir, nelfinavir) or rilpivirine-containing products. 5. Abnormal blood chemistry values within 4 weeks prior to screening: AST, ALT, ALP, or total bilirubin \> 3 times the upper limit of normal (ULN). Estimated Glomerular Filtration Rate (eGFR) \< 30 mL/min/1.73m², calculated using the IDMS-traceable MDRD equation. 6. Recent Medication Use: Use of medications expected to affect the study results, such as P2Y12 inhibitors (other than the prescribed clopidogrel), within 2 weeks prior to baseline. 7. Pregnant or lactating women, or women with a positive pregnancy test. 8. Patients with hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of platelet reactivity using P2Y12 Reaction Units (PRU) by the VerifyNow assay at 1 month | 1 month | Assessment of platelet reactivity using P2Y12 Reaction Units (PRU) by the VerifyNow assay at 1 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Platelet Reactivity | 1 month, 3 months, and 6 months | Change in Platelet Reactivity |
| Proportion of Participants Achieving Platelet Reactivity Within the Therapeutic Range | 1 month | Change in Platelet Reactivity |
| Incidence of Major Adverse Cardiovascular Events (MACE) | 6 month | Composite of cardiovascular death, myocardial infarction, or stroke. |
| Incidence of Individual Components of Major Adverse Cardiovascular Events (MACE) | 6 month | Cardiovascular death, myocardial infarction, and stroke evaluated separately. |
| Incidence of Coronary Revascularization | 6 month | Incidence of Coronary Revascularization |
| All-cause Mortality | 6 month | All-cause Mortality |
| Incidence of Upper Gastrointestinal (GI) Bleeding | 6 month | Incidence of Upper Gastrointestinal (GI) Bleeding |
| Incidence of Bleeding Events According to BARC Criteria (Types 2, 3, or 5) | 6 month | Incidence of Bleeding Events According to BARC Criteria (Types 2, 3, or 5) |
| Incidence of Adverse Drug Reactions (ADRs) | 6 month | Incidence of Adverse Drug Reactions (ADRs) |
Countries
South Korea
Contacts
CONTACTYongcheol Kim, MD, PhD
Outcome results
None listed