Cytoprotective Agent and Peptic Ulcer in Dual Antiplatelet :RCT
Cytoprotective Agent for Peptic Ulcer Prevention in Patients Taking Dual Antiplatelet Agents: A Randomized Double-blind Placebo Control Trial Study
1 other identifier
interventional
142
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2014
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2013
CompletedFirst Posted
Study publicly available on registry
June 18, 2014
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedFebruary 27, 2019
February 1, 2019
2.9 years
September 30, 2013
February 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
number of peptic ulcer by end0scopy
1 year
Study Arms (2)
Repamipide
ACTIVE COMPARATORRebamipide (100) 1 tab oral tid for 1 year or peptic ulcer occurred
placebo
PLACEBO COMPARATORA 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.
Interventions
Eligibility Criteria
You may qualify if:
- Age 18-70 year-old
- Had cardiovascular disease which needed clopidogrel and aspirin
- Stable enough for gastroscopy
You may not qualify if:
- Gastroscopy revealed peptic ulcer
- Had contraindication for gastroscopy
- Not allowed for gastroscopy by cardiologist
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
King Chulalongkorn Memorial Hospital
Patumwan, Bangkok, 10330, Thailand
Related Publications (1)
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.
PMID: 30919492DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
September 30, 2013
First Posted
June 18, 2014
Study Start
July 1, 2014
Primary Completion
June 1, 2017
Study Completion
June 1, 2018
Last Updated
February 27, 2019
Record last verified: 2019-02