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

NCT07471867 | Recruiting Phase 4 DMC

• 1 other identifier: 9-2025-0234
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Coronary Syndrome

Keywords

Chronic Coronary Syndrome; zastaprazan

Outcome Measures

Primary Outcomes (1)

• 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

  1 month

Secondary Outcomes (9)

• Change in Platelet Reactivity

  1 month, 3 months, and 6 months

• Proportion of Participants Achieving Platelet Reactivity Within the Therapeutic Range

  1 month

• Incidence of Major Adverse Cardiovascular Events (MACE)

  6 month

• Incidence of Individual Components of Major Adverse Cardiovascular Events (MACE)

  6 month

• Incidence of Coronary Revascularization

  6 month

Study Arms (2)

zastaprazan 20mg

EXPERIMENTAL

Participants receive zastaprazan 20mg and Placebo matching Pariet 10mg tablet 10mg.

Drug: Rabeprazole

Pariet 10mg

EXPERIMENTAL

Participants receive Pariet 10mg and Placebo matching zastaprazan 20mtablet 10mg.

Drug: Zastaprazan

Interventions

Zastaprazan DRUG

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).

Pariet 10mg

Rabeprazole DRUG

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

zastaprazan 20mg

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.
• Pregnant or lactating women, or women with a positive pregnancy test.
• Patients with hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.

Sponsors & Collaborators

• Jeil Pharmaceutical Co., Ltd.: collaborator
• Yonsei University: lead

Study Sites (1)

Yongin Severance Hospital, Yonsei University

Yongin-si, Gyeonggi-do, 16995, South Korea

RECRUITING

MeSH Terms

Interventions

Rabeprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Yongcheol Kim, MD, PhD

CONTACT

+82-031-5189-8967; yongcheol@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 13, 2026
• Study Start: April 2, 2026
• Primary Completion (Estimated): July 12, 2028
• Study Completion (Estimated): July 12, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)