NCT02175186

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2015

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 26, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

January 21, 2015

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2019

Completed
Last Updated

March 22, 2023

Status Verified

March 1, 2023

Enrollment Period

3.9 years

First QC Date

June 25, 2014

Last Update Submit

March 21, 2023

Conditions

GastritisGastroduodenal Ulcer

Keywords

GastritisGastroduodenal UlcerPercutaneous Coronary RevascularizationDual Antiplatelet Therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Incidence of gastritis

    12weeks

  • The Endoscopic improvement rate of hemorrhage

    12weeks

  • The Endoscopic improvement rate of subjective symptom

    12weeks

  • Total amount of antacid used during study period

    12weeks

Study Arms (2)

ALBIS

EXPERIMENTAL

Albis Tab 2 tab twice a day 12weeks

Drug: ALBIS

Placebo

PLACEBO COMPARATOR

placebo Tab 2 tab twice a day 12weeks

Drug: Placebo

Interventions

ALBISDRUG
ALBIS
PlaceboDRUG
Placebo

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, Songpa-Gu, South Korea

Location

MeSH Terms

Conditions

GastritisPeptic Ulcer

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesStomach DiseasesDuodenal DiseasesIntestinal Diseases

Study Officials

  • Young-Hak Kim, MD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD,PhD

Study Record Dates

First Submitted

June 25, 2014

First Posted

June 26, 2014

Study Start

January 21, 2015

Primary Completion

December 1, 2018

Study Completion

January 8, 2019

Last Updated

March 22, 2023

Record last verified: 2023-03

Locations

KR(1)