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

Gastritis Clinical Trial

— DAPTALBIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02175186
• Other study ID #: AMCCV 2014-05
• Status: Completed
• Phase: Phase 4
• Start date: January 21, 2015
• Est. completion date: January 8, 2019

Study information

• Verified date: March 2023
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: January 8, 2019
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastritis
• Gastroduodenal Ulcer
• Peptic Ulcer

Intervention

Drug:
• ALBIS

• Placebo

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul	Songpa-Gu

Sponsors (1)

Lead Sponsor	Collaborator
Young-Hak Kim, MD, PhD

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of gastric ulcer	defined as a mucosal break of at least 5 mm in diameter(measured by gastrointestinal endoscopy) with depth, at 12weeks	12weeks
Secondary	Incidence of gastritis	defined as Modified Lanza Score(MLS) grade 2~4(measured by gastrointestinal endoscopy)at 12weeks	12weeks
Secondary	The Endoscopic improvement rate of hemorrhage	defined as Modified Lanza Score(MLS) grade	12weeks
Secondary	The Endoscopic improvement rate of subjective symptom		12weeks
Secondary	Total amount of antacid used during study period		12weeks