Protective Effect of ALBIS on Gastroduodenal Mucosal Injury in Patients Receiving Dual Antiplatelet Therapy After Percutaneous Coronary Intervention

AMCCV 2014-05

The purpose of this study is to evaluate effectiveness of ALBIS on Gastroduodenal Mucosal Injury in Patients Receiving Dual Antiplatelet Therapy after Percutaneous Coronary Intervention.

2015-01-21

2018-12-01

2019-01-08

Completed

Early phase I

47

Inclusion Criteria: * Age between 20 and 80 years * Patients undergoing percutaneous coronary intervention and need to take dual antiplatelet therapy continuously at least 12weeks * Modified Lanza Score grade 0-1 measured by upper gastrointestinal endoscopy * mild gastrointestinal symptom * Creatinen in blood ≤ 3mg/dl * BUN ≤ 50mg/dl * Birilubin ≤ 3mg/dl * AST and ALT ≤ 80U/L Exclusion Criteria: * Pregnant or breast feeding * History of Stomach or esophagus surgery * Peptic ulcer or reflux esophagitis * Zollinger-Ellison syndrome or primary esophageal motility disorders * Malignant tumor * Bleeding tendency or coagulopathy * Contraindication of ALBIS * Long term use of aspirin or P2Y12 receptor antagonist within 1month * Patients who tool medicine such as PPI, APA,H2blocker, Muscarine receptor antagonist, anti-gastic agent, antacid, anticaogulant, Bisphosphonate agents, Cytotoxic drug, NSAID, adrenal cortex hormone agents (topical treatment is allowed) * Terminal patient

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 47, 'type': 'ACTUAL'}}

2023-03-22