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

March 21, 2023 updated by: Young-Hak Kim, MD, PhD

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ALBIS
Albis Tab 2 tab twice a day 12weeks
Drug: ALBIS
Placebo Comparator: Placebo
placebo Tab 2 tab twice a day 12weeks
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of gastric ulcer
Time Frame: 12weeks
defined as a mucosal break of at least 5 mm in diameter(measured by gastrointestinal endoscopy) with depth, at 12weeks
12weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Young-Hak Kim, MD, PhD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2015

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

January 8, 2019

Study Registration Dates

First Submitted

June 25, 2014

First Submitted That Met QC Criteria

June 25, 2014

First Posted (Estimate)

June 26, 2014

Study Record Updates

Last Update Posted (Actual)

March 22, 2023

Last Update Submitted That Met QC Criteria

March 21, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMCCV 2014-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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