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Cytoprotective Agent and Peptic Ulcer in Dual Antiplatelet :RCT

Primary Purpose

Gastric Ulcer Induced by Anti-platelet Agent, Duodenal Ulcer Induced by Anti-platelet Agent

Status
Completed
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
Repamipide
Placebo
Sponsored by
King Chulalongkorn Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Ulcer Induced by Anti-platelet Agent focused on measuring Repamipide, Dual antiplatelet, Peptic ulcer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18-70 year-old
  2. Had cardiovascular disease which needed clopidogrel and aspirin
  3. Stable enough for gastroscopy

Exclusion Criteria:

  1. Gastroscopy revealed peptic ulcer
  2. Had contraindication for gastroscopy
  3. Not allowed for gastroscopy by cardiologist

Sites / Locations

  • King Chulalongkorn Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Repamipide

placebo

Arm Description

Rebamipide (100) 1 tab oral tid for 1 year or peptic ulcer occurred

A placebo is a simulated or otherwise medically ineffectual treatment for a disease or other medical condition intended to deceive the recipient. It will be prescribed as the same regimen of Rabamipide.

Outcomes

Primary Outcome Measures

number of peptic ulcer by end0scopy

Secondary Outcome Measures

Full Information

First Posted
September 30, 2013
Last Updated
February 26, 2019
Sponsor
King Chulalongkorn Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02166008
Brief Title
Cytoprotective Agent and Peptic Ulcer in Dual Antiplatelet :RCT
Official Title
Cytoprotective Agent for Peptic Ulcer Prevention in Patients Taking Dual Antiplatelet Agents: A Randomized Double-blind Placebo Control Trial Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
July 2014 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Chulalongkorn Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Primary objective : To evaluate the efficacy of Rapamide in peptic ulcer prevention in patients taking dual antiplatelet agents Study Design: Single center, double-blind, randomized-control trial study Study drug: Repamipide vs. placebo Assessment criteria The patients will be discharged from the study when one of the followings occurred, Peptic ulcer from upper endoscopy at 3 and 6 month follow up Clinical of upper gastrointestinal bleeding with peptic ulcer from upper endoscopy Anemia by CBC at 1,3 ,6,12 month with peptic ulcer from upper endoscopy Evidence of recurrent myocardial infarction from stent thrombosis

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Ulcer Induced by Anti-platelet Agent, Duodenal Ulcer Induced by Anti-platelet Agent
Keywords
Repamipide, Dual antiplatelet, Peptic ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
142 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Repamipide
Arm Type
Active Comparator
Arm Description
Rebamipide (100) 1 tab oral tid for 1 year or peptic ulcer occurred
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
A placebo is a simulated or otherwise medically ineffectual treatment for a disease or other medical condition intended to deceive the recipient. It will be prescribed as the same regimen of Rabamipide.
Intervention Type
Drug
Intervention Name(s)
Repamipide
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo will be made in the same configuration of rabamipide
Primary Outcome Measure Information:
Title
number of peptic ulcer by end0scopy
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-70 year-old Had cardiovascular disease which needed clopidogrel and aspirin Stable enough for gastroscopy Exclusion Criteria: Gastroscopy revealed peptic ulcer Had contraindication for gastroscopy Not allowed for gastroscopy by cardiologist
Facility Information:
Facility Name
King Chulalongkorn Memorial Hospital
City
Patumwan
State/Province
Bangkok
ZIP/Postal Code
10330
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
30919492
Citation
Pittayanon R, Piyachaturawat P, Rerknimitr R, Prueksapanich P, Chaitongrat S, Lertsuwunseri V, Srimahachota S, Mahachai V. Cytoprotective agent for peptic ulcer prevention in patients taking dual antiplatelet agents: A randomized, double-blind placebo-controlled trial. J Gastroenterol Hepatol. 2019 Sep;34(9):1517-1522. doi: 10.1111/jgh.14671. Epub 2019 May 8.
Results Reference
derived
Links:
URL
http://www.medchulairb.com
Description
Institutional review board, Faculty of medicine, Chulalongkorn University

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Cytoprotective Agent and Peptic Ulcer in Dual Antiplatelet :RCT

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