None listed
Conditions
Interventions
Drug : Experimental Group:
ZAQBO (20 mg, 1 tablet) + Placebo of Pariet (10 mg, 1 tablet) (Total: 2 tablets) administered orally once daily.
Control Group:
Pariet (10 mg, 1 tablet) + Placebo of Zacubo
Sponsors
Seoul National University Bundang Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients aged 19 years or older. 2) Patients who have undergone Percutaneous Coronary Intervention (PCI) and are planned for Dual Antiplatelet Therapy (DAPT). 3) Patients who have voluntarily provided written informed consent to participate in this study. 4) Patients meeting the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria, specifically fulfilling at least one Major criterion or at least two Minor criteria. Major Criteria 1) History of peptic ulcer. 2) Anticipated long-term use of oral anticoagulants 3) Severe chronic kidney disease or end-stage renal disease (eGFR < 30 mL/min) 4) Hemoglobin < 11g/dL 5) Spontaneous bleeding requiring hospitalization or transfusion within the past 6 months, or recurrent bleeding 6) Moderate or severe thrombocytopenia (platelet count < 100×10?/L) 7) Chronic bleeding diathesis (tendency) 8) Liver cirrhosis with portal hypertension 9) Active malignancy (excluding non-melanoma skin cancer) within the past 12 months 10) Prior spontaneous intracranial hemorrhage (at any time) 11) Traumatic intracranial hemorrhage within the past 12 months 12) Presence of brain arteriovenous malformation (bAVM) 13) Moderate or severe ischemic stroke (NIHSS =5) within the past 6 months Minor Criteria 1) Age =75 years 2) Moderate chronic kidney disease (eGFR 30–59 mL/min) 3) Hemoglobin 11–12.9 g/dL for men, 11–11.9 g/dL for women 4) Spontaneous bleeding requiring hospitalization or transfusion within the past 12 months that does not meet major criteria. 5) History of ischemic stroke not meeting major criteria 6) Long-term use of oral NSAIDs or systemic steroids
Exclusion criteria
Exclusion criteria: 1) Inability to provide informed consent: Patients who are unable to provide voluntary informed consent. 2) Patients with a life expectancy of less than one year due to non-cardiovascular causes. 3) Patients with a known hypersensitivity or a history of allergic reactions to any components of the investigational product(s). 4) Women who are pregnant, breastfeeding, or planning to become pregnant during the study period. 5) Patients with current active bleeding or a history of congenital or acquired bleeding disorders. 6) Patients with clinical contraindications to the use of antithrombotic agents, Proton Pump Inhibitors (PPIs), or Potassium-Competitive Acid Blockers (P-CABs). 7) Patients presenting with one or more of the following hemodynamically unstable conditions: - Cardiogenic shock at the time of randomization. - Refractory ventricular arrhythmia. - Congestive heart failure, specifically NYHA Class IV.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Upper gastrointesinal clinical event at 1year(GI Bleeding, Peptic Ulcer, Perforation, Obstruction) | — |
Secondary
| Measure | Time frame |
|---|---|
| Major adverse cardiovascular events at 1year(Death, MI, Repeat Revascularization, CVA, Stent Thrombosis) | — |
Countries
Korea, Republic of
Contacts
Public ContactGimi Park
Seoul National University Bundang Hospital
Outcome results
None listed