Effect of ALBIS on Gastroduodenal Mucosal Injury in Patie... | NCT02175186

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

NCT02175186

Sponsor

Young-Hak Kim, MD, PhD

Status

Completed

Last Update Posted

Mar 22, 2023Actual

Enrollment

47Actual

Phase

Phase 4

Conditions

Gastritis
Gastroduodenal Ulcer

Interventions

ALBIS
Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 21, 2015Actual

Primary Completion Date

Dec 1, 2018Actual

Completion Date

Jan 8, 2019Actual

First Submitted Date

Jun 25, 2014

First Submission Date that Met QC Criteria

Jun 25, 2014

First Posted Date

Jun 26, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 21, 2023

Last Update Posted Date

Mar 22, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

47Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
ALBIS	Drug		ALBIS
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Incidence of gastritis	defined as Modified Lanza Score(MLS) grade 2~4(measured by gastrointestinal endoscopy)at 12weeks	12weeks
The Endoscopic improvement rate of hemorrhage	defined as Modified Lanza Score(MLS) grade

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Young-Hak Kim, MD	Asan Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asan Medical Center		Seoul	Songpa-Gu		South Korea

Condition Browse Module

MeSH Terms

ID	Term
D005756	Gastritis
D010437	Peptic Ulcer

Ancestor Terms

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D013272	Stomach Diseases

Browse Leaves

Not provided

Browse Branches

Not provided