Cytoprotective Agent and Peptic Ulcer in Dual Antiplatelet :RCT
NCT ID: NCT02166008
Last Updated: 2019-02-27
Study Results
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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COMPLETED
PHASE2/PHASE3
142 participants
INTERVENTIONAL
2014-07-31
2018-06-30
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Repamipide
Rebamipide (100) 1 tab oral tid for 1 year or peptic ulcer occurred
Repamipide
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.
Placebo
Interventions
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Repamipide
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Had cardiovascular disease which needed clopidogrel and aspirin
3. Stable enough for gastroscopy
Exclusion Criteria
2. Had contraindication for gastroscopy
3. Not allowed for gastroscopy by cardiologist
18 Years
70 Years
ALL
No
Sponsors
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King Chulalongkorn Memorial Hospital
OTHER
Responsible Party
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Rapat Pittayanon, MD
Doctor
Locations
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King Chulalongkorn Memorial Hospital
Patumwan, Bangkok, Thailand
Countries
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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.
Related Links
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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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