Cytoprotective Agent and Peptic Ulcer in Dual Antiplatelet :RCT

February 26, 2019 updated by: Rapat Pittayanon, MD, King Chulalongkorn Memorial Hospital

Cytoprotective Agent for Peptic Ulcer Prevention in Patients Taking Dual Antiplatelet Agents: A Randomized Double-blind Placebo Control Trial Study

  • 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,

    1. Peptic ulcer from upper endoscopy at 3 and 6 month follow up
    2. Clinical of upper gastrointestinal bleeding with peptic ulcer from upper endoscopy
    3. Anemia by CBC at 1,3 ,6,12 month with peptic ulcer from upper endoscopy
    4. Evidence of recurrent myocardial infarction from stent thrombosis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

142

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Patumwan, Bangkok, Thailand, 10330
        • King Chulalongkorn Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Repamipide
Rebamipide (100) 1 tab oral tid for 1 year or peptic ulcer occurred
Drug: Repamipide
Placebo Comparator: placebo
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.
Drug: Placebo
Other Names:
  • Placebo will be made in the same configuration of rabamipide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of peptic ulcer by end0scopy
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Chulalongkorn Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2014

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

September 30, 2013

First Submitted That Met QC Criteria

June 12, 2014

First Posted (Estimate)

June 18, 2014

Study Record Updates

Last Update Posted (Actual)

February 27, 2019

Last Update Submitted That Met QC Criteria

February 26, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RP006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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