Back to results

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

Primary Purpose

Gastritis, Gastroduodenal Ulcer

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

ALBIS

Placebo

About this trial

This is an interventional treatment trial for Gastritis focused on measuring Gastritis, Gastroduodenal Ulcer, Percutaneous Coronary Revascularization, Dual Antiplatelet Therapy

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ALBIS

Placebo

Arm Description

Albis Tab 2 tab twice a day 12weeks

placebo Tab 2 tab twice a day 12weeks

Outcomes

Primary Outcome Measures

Incidence of gastric ulcer

defined as a mucosal break of at least 5 mm in diameter(measured by gastrointestinal endoscopy) with depth, at 12weeks

Secondary Outcome Measures

Incidence of gastritis

defined as Modified Lanza Score(MLS) grade 2~4(measured by gastrointestinal endoscopy)at 12weeks

The Endoscopic improvement rate of hemorrhage

defined as Modified Lanza Score(MLS) grade

The Endoscopic improvement rate of subjective symptom

Total amount of antacid used during study period

Full Information

NCT ID

NCT02175186

First Posted

June 25, 2014

Last Updated

March 21, 2023

Sponsor

Young-Hak Kim, MD, PhD

1. Study Identification

Unique Protocol Identification Number

NCT02175186

Brief Title

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

Acronym

DAPTALBIS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

January 21, 2015 (Actual)

Primary Completion Date

December 1, 2018 (Actual)

Study Completion Date

January 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Young-Hak Kim, MD, PhD

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastritis, Gastroduodenal Ulcer

Keywords

Gastritis, Gastroduodenal Ulcer, Percutaneous Coronary Revascularization, Dual Antiplatelet Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

47 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ALBIS

Arm Type

Experimental

Arm Description

Albis Tab 2 tab twice a day 12weeks

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

placebo Tab 2 tab twice a day 12weeks

Intervention Type

Drug

Intervention Name(s)

ALBIS

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Incidence of gastric ulcer

Description

defined as a mucosal break of at least 5 mm in diameter(measured by gastrointestinal endoscopy) with depth, at 12weeks

Time Frame

12weeks

Secondary Outcome Measure Information:

Title

Incidence of gastritis

Description

defined as Modified Lanza Score(MLS) grade 2~4(measured by gastrointestinal endoscopy)at 12weeks

Time Frame

12weeks

Title

The Endoscopic improvement rate of hemorrhage

Description

defined as Modified Lanza Score(MLS) grade

Time Frame

12weeks

Title

The Endoscopic improvement rate of subjective symptom

Time Frame

12weeks

Title

Total amount of antacid used during study period

Time Frame

12weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Young-Hak Kim, MD

Organizational Affiliation

Asan Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Asan Medical Center

City

Seoul

State/Province

Songpa-Gu

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs