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

Phase 4

Completed

• Conditions: Gastritis; Gastroduodenal Ulcer
• Interventions: Drug: ALBIS; Drug: Placebo

• Registration Number: NCT02175186
• Lead Sponsor: Young-Hak Kim, MD, PhD

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-25
• Study First Submitted QC: 2014-06-25
• Study First Posted: 2014-06-26
• Study Start: 2015-01-21
• Primary Completion: 2018-12-01
• Study Completion: 2019-01-08
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ALBIS	ALBIS	Albis Tab 2 tab twice a day 12weeks
Placebo	Placebo	placebo Tab 2 tab twice a day 12weeks

Primary Outcome Measures

Name	Time	Method
Incidence of gastric ulcer	12weeks	defined as a mucosal break of at least 5 mm in diameter(measured by gastrointestinal endoscopy) with depth, at 12weeks

Secondary Outcome Measures

Name	Time	Method
The Endoscopic improvement rate of subjective symptom	12weeks
Total amount of antacid used during study period	12weeks
Incidence of gastritis	12weeks	defined as Modified Lanza Score(MLS) grade 2\~4(measured by gastrointestinal endoscopy)at 12weeks
The Endoscopic improvement rate of hemorrhage	12weeks	defined as Modified Lanza Score(MLS) grade

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Songpa-Gu, Korea, Republic of