None listed
Conditions
Interventions
Drug : Test Drug: Zastaprazan (Jaquvo®) 20 mg, administered orally once daily (P-CAB group)
Control Drug: Rabeprazole (Pariet®) 10 mg, administered orally once daily (PPI group)
A total of two tablet
Sponsors
Yonsei University Yongin Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who are 19 years of age or older at the time of providing informed consent 2. Patients diagnosed with chronic coronary syndrome (CCS) who have undergone percutaneous coronary intervention (PCI) and have agreed to participate in the study. 3. Patients required to maintain dual antiplatelet therapy (DAPT), including aspirin and clopidogrel, for at least 6 months following percutaneous coronary intervention (PCI). 4. Patients who have voluntarily provided written informed consent to participate in this clinical study.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of hypersensitivity to P-CAB or PPI class ingredients, benzimidazoles, aspirin, or clopidogrel. 2. Patients who have a history of, or are scheduled for, surgery that may affect gastric acid secretion, such as upper gastrointestinal resection, acid suppression surgery, or gastric mucosal resection. (However, those who have undergone simple perforation repair of the stomach or duodenum, appendectomy, cholecystectomy, hysterectomy, laparoscopic benign tumor resection, or endoscopic benign tumor resection are eligible to participate.) 3. Patients with Zollinger-Ellison syndrome or inflammatory diseases (including inflammatory bowel disease such as Crohn's disease or ulcerative colitis, and pancreatitis). 4. Patients currently receiving HIV protease inhibitors (atazanavir, nelfinavir) or rilpivirine-containing preparations. 5. Patients who show the following abnormal blood chemistry values within 4 weeks prior to the screening date: - AST, ALT, ALP, or total bilirubin exceeding 3 times the upper limit of normal (ULN) of the institution. -Subjects with an eGFR less than 30 mL/min/1.73 m2. eGFR (IDMS-MDRD) (mL/min/1.73 m2) = 175 ×(Serum Creatinine Concentration(mg/dl))-1.154 × (Age (years) Full years of age)-0.203 (× 0.742,if female) 6. Subjects who have received medications expected to affect the study results, such as P2Y12 inhibitors, within 2 weeks prior to baseline. 7. Pregnant or lactating women Women who are pregnant or lactating, or those with a positive pregnancy test; individuals (male or female) planning for pregnancy during the study period; or those of childbearing potential (including female partners of male subjects) who are not surgically sterile and do not agree to use the specified contraceptive methods during the stud. ? Applicable to both female subjects and female partners of male subjects, acceptable contraceptive methods include the use of an intrauterine device (IUD), tubal ligation or other surgical sterilization, or the combination of a condom or diaphragm with spermicide. ? Male subjects only (not applicable to male partners of female subjects): Condom *Oral or implantable hormonal contraceptives are not considered acceptable methods of contraception for this study; however, the use of oral hormonal contraceptives by the spouses or female partners of male subjects is permitted. 8. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of platelet reactivity (Measurement of P2Y12 Reaction Units [PRU] using the VerifyNow assay) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in platelet reactivity;Achievement of platelet reactivity within the therapeutic range;Composite cardiovascular events (Cardiovascular death, myocardial infarction, or ischemic stroke);Each component of the composite cardiovascular endpoints;Coronary revascularization;All-cause death;Upper gastrointestinal (UGI) bleeding;BARC type 2, 3, or 5 bleeding;Adverse drug reactions (ADRs) of Zacuovo or Pariet | — |
Countries
Korea, Republic of
Contacts
Public ContactYONGCHEOL KIM
Yonsei University Yongin Severance Hospital
Outcome results
None listed