Cytoprotective Agent and Peptic Ulcer in Dual Antiplatelet :RCT

NCT ID: NCT02166008

Last Updated: 2019-02-27

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

PHASE2/PHASE3

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2018-06-30

Brief Summary

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* 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

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Repamipide

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

Group Type ACTIVE_COMPARATOR

Repamipide

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Repamipide

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Placebo will be made in the same configuration of rabamipide

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Chulalongkorn Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rapat Pittayanon, MD

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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King Chulalongkorn Memorial Hospital

Patumwan, Bangkok, Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type DERIVED
PMID: 30919492 (View on PubMed)

Related Links

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http://www.medchulairb.com

Institutional review board, Faculty of medicine, Chulalongkorn University

Other Identifiers

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RP006

Identifier Type: -

Identifier Source: org_study_id

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