Chronic Coronary SyndromePhase 4EZ-STARNCT07471867
Effect of ZaStaprazan on Platelet Reactivity of Clopidogrel After PercuTaneous CoronAry InteRvention
A Phase 4 study testing Zastaprazan and Rabeprazole in people with Chronic Coronary Syndrome, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Coronary Syndrome
- What is being tested?
- Zastaprazan and Rabeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Apr 2026to 12 Jul 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Yongin Severance Hospital, Yonsei University
Yongin-si, Gyeonggi-do, 16995
Yongcheol Kim, MD, +823151898967, yongcheol@yuhs.ac
About this study
Official title: Effect of ZaStaprazan on Platelet Reactivity of Clopidogrel After PercuTaneous CoronAry InteRvention: A Randomized Double-Blind Pilot Study (EZ-STAR)
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.
Read the 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.
- Conditions
- Chronic Coronary Syndrome
- Being tested
- Zastaprazan, Rabeprazole
- Keywords
- Chronic Coronary Syndrome, zastaprazan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZastaprazanDrug
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).
RabeprazoleDrug
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 group | Role | What they receive |
|---|---|---|
| zastaprazan 20mg | Experimental | Participants receive zastaprazan 20mg and Placebo matching Pariet 10mg tablet 10mg. Receives: Drug: Rabeprazole |
| Pariet 10mg | Experimental | Participants receive Pariet 10mg and Placebo matching zastaprazan 20mtablet 10mg. Receives: Drug: Zastaprazan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Secondary outcomes (9)
Change in Platelet Reactivity
Change in Platelet Reactivity
Measured: 1 month, 3 months, and 6 months
Proportion of Participants Achieving Platelet Reactivity Within the Therapeutic Range
Change in Platelet Reactivity
Measured: 1 month
Incidence of Major Adverse Cardiovascular Events (MACE)
Composite of cardiovascular death, myocardial infarction, or stroke.
Measured: 6 month
Incidence of Individual Components of Major Adverse Cardiovascular Events (MACE)
Cardiovascular death, myocardial infarction, and stroke evaluated separately.
Measured: 6 month
Incidence of Coronary Revascularization
Incidence of Coronary Revascularization
Measured: 6 month
All-cause Mortality
All-cause Mortality
Measured: 6 month
Incidence of Upper Gastrointestinal (GI) Bleeding
Incidence of Upper Gastrointestinal (GI) Bleeding
Measured: 6 month
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)
Measured: 6 month
Incidence of Adverse Drug Reactions (ADRs)
Incidence of Adverse Drug Reactions (ADRs)
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start2 Apr 2026
- Primary completion12 Jul 2028 (estimated)
- Study completion12 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Collaborators
- Jeil Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Yongcheol Kim, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07471867
- Sponsor's protocol ID
- 9-2025-0234
- Acronym
- EZ-STAR
- Status last verified
- Apr 2026
- First submitted
- 4 Mar 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of ZaStaprazan on Platelet Reactivity of Clopidogrel After PercuTaneous CoronAry InteRvention: A Randomized Double-Blind Pilot Study (EZ-STAR)
- ClinicalTrials.gov ID
- NCT07471867
- Acronym / sponsor ID
- EZ-STAR / 9-2025-0234
- Conditions
- Chronic Coronary Syndrome
- Keywords
- Chronic Coronary Syndrome, zastaprazan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Collaborators
- Jeil Pharmaceutical Co., Ltd.
- Study start
- 2 Apr 2026 (actual)
- Primary completion
- 12 Jul 2028 (estimated)
- Study completion
- 12 Jul 2028 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| zastaprazan 20mg | Experimental | Drug: RabeprazoleParticipants receive zastaprazan 20mg and Placebo matching Pariet 10mg tablet 10mg. |
| Pariet 10mg | Experimental | Drug: ZastaprazanParticipants receive Pariet 10mg and Placebo matching zastaprazan 20mtablet 10mg. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZastaprazanParticipants will receive Zastaprazan [20 mg] orally once daily for [6 month] in addition to standard dual antiplatelet therapy (DAPT) including clopidogrel (75 mg/day). | Drug | Pariet 10mg |
| RabeprazoleParticipants will receive Rabeprazole [10 mg] orally once daily for [6month] in addition to standard dual antiplatelet therapy (DAPT) including clopidogrel (75 mg/day). | Drug | zastaprazan 20mg |
Primary outcome
Assessment of platelet reactivity using P2Y12 Reaction Units (PRU) by the VerifyNow assay at 1 month
Time frame: 1 month
Assessment of platelet reactivity using P2Y12 Reaction Units (PRU) by the VerifyNow assay at 1 month
9 secondary outcomes
Change in Platelet Reactivity
Time frame: 1 month, 3 months, and 6 months
Proportion of Participants Achieving Platelet Reactivity Within the Therapeutic Range
Time frame: 1 month
Incidence of Major Adverse Cardiovascular Events (MACE)
Time frame: 6 month
Incidence of Individual Components of Major Adverse Cardiovascular Events (MACE)
Time frame: 6 month
Incidence of Coronary Revascularization
Time frame: 6 month
All-cause Mortality
Time frame: 6 month
Incidence of Upper Gastrointestinal (GI) Bleeding
Time frame: 6 month
Incidence of Bleeding Events According to BARC Criteria (Types 2, 3, or 5)
Time frame: 6 month
Incidence of Adverse Drug Reactions (ADRs)
Time frame: 6 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zastaprazan and Rabeprazole in people with Chronic Coronary Syndrome, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yongcheol Kim, MD, PhD (+82-031-5189-8967, yongcheol@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of platelet reactivity using P2Y12 Reaction Units (PRU) by the VerifyNow assay at 1 month (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.