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Recruiting Phase 4

Effect of ZaStaprazan on Platelet Reactivity of Clopidogrel After PercuTaneous CoronAry InteRvention

NCT07471867 · tracked via the Priya Life Science South Korea tracker
Phase
Phase 4
Started
2026-04-02
Last updated
2026-04-24

Condition(s) studied

Chronic Coronary Syndrome

Investigational drug(s) / intervention(s)

Zastaprazan →Rabeprazole →

Zastaprazan: 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).

Rabeprazole: Participants will receive Rabeprazole \[10 mg\] orally once daily for \[6month\] in addition to standard dual antiplatelet therapy (DAPT) including clopidogrel (75 mg/day).

Study 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.

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
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.

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Yongin Severance Hospital, Yonsei University Yongin-si Gyeonggi-do Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07471867 on ClinicalTrials.gov ↗ ← All trials in South Korea