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

NCT ID: NCT02175186

Last Updated: 2023-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-21

Study Completion Date

2019-01-08

Brief Summary

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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

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Conditions

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Gastritis Gastroduodenal Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ALBIS

Albis Tab 2 tab twice a day 12weeks

Group Type EXPERIMENTAL

ALBIS

Intervention Type DRUG

Placebo

placebo Tab 2 tab twice a day 12weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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ALBIS

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Young-Hak Kim, MD, PhD

OTHER

Sponsor Role lead

Responsible Party

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Young-Hak Kim, MD, PhD

MD,PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Young-Hak Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Asan Medical Center

Seoul, Songpa-Gu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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AMCCV 2014-05

Identifier Type: -

Identifier Source: org_study_id

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