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| Name | Class |
|---|---|
| Jeil Pharmaceutical Co., Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| zastaprazan 20mg | Experimental | Participants receive zastaprazan 20mg and Placebo matching Pariet 10mg tablet 10mg. |
|
| Pariet 10mg | Experimental | Participants receive Pariet 10mg and Placebo matching zastaprazan 20mtablet 10mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Platelet Reactivity | Change in Platelet Reactivity | 1 month, 3 months, and 6 months |
| Proportion of Participants Achieving Platelet Reactivity Within the Therapeutic Range | Change in Platelet Reactivity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongcheol Kim, MD, PhD | Contact | +82-031-5189-8967 | yongcheol@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yongin Severance Hospital, Yonsei University | Recruiting | Yongin-si | Gyeonggi-do | 16995 | South Korea |
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| ID | Term |
|---|---|
| D064750 | Rabeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| 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). |
|
| 1 month |
| Incidence of Major Adverse Cardiovascular Events (MACE) | Composite of cardiovascular death, myocardial infarction, or stroke. | 6 month |
| Incidence of Individual Components of Major Adverse Cardiovascular Events (MACE) | Cardiovascular death, myocardial infarction, and stroke evaluated separately. | 6 month |
| Incidence of Coronary Revascularization | Incidence of Coronary Revascularization | 6 month |
| All-cause Mortality | All-cause Mortality | 6 month |
| Incidence of Upper Gastrointestinal (GI) Bleeding | Incidence of Upper Gastrointestinal (GI) Bleeding | 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) | 6 month |
| Incidence of Adverse Drug Reactions (ADRs) | Incidence of Adverse Drug Reactions (ADRs) | 6 month |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |