Efficacy of Proton Pump Inhibitor in Prevention of Clopidogrel-related Peptic Ulcer
1 other identifier
interventional
165
1 country
1
Brief Summary
Proton Pump Inhibitors (PPI) can prevent the recurrence of peptic ulcer in clopidogrel users.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2008
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
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 7, 2010
CompletedFirst Posted
Study publicly available on registry
June 8, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedResults Posted
Study results publicly available
February 4, 2013
CompletedSeptember 9, 2015
September 1, 2015
4.3 years
June 7, 2010
December 31, 2012
September 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recurrent Peptic Ulcer
Number of participants with recurrent peptic ulcer within 6 months
6 months
Secondary Outcomes (1)
Peptic Ulcer Bleeding
6 months
Study Arms (2)
Esomeprazole plus clopidogrel group
ACTIVE COMPARATOResomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months
Clopidogrel group
NO INTERVENTIONclopidogrel 75 mg qd for 6 months
Interventions
esomeprazole 20 mg qd for 6 months
Eligibility Criteria
You may qualify if:
- We plan to enroll 300 clopidogrel users without baseline gastroduodenal ulcer at initial endoscopy. The patients will be randomly assigned to receive either (1) esomeprazole (20 mg qd) plus clopidogrel or (2) clopidogrel treatment alone for 6 months.
You may not qualify if:
- serious disease 2.refuse informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kaohsiung Veterans General Hospital
Kaohsiung City, 813, Taiwan
Related Publications (1)
Hsu PI, Lai KH, Liu CP. Esomeprazole with clopidogrel reduces peptic ulcer recurrence, compared with clopidogrel alone, in patients with atherosclerosis. Gastroenterology. 2011 Mar;140(3):791-8. doi: 10.1053/j.gastro.2010.11.056. Epub 2010 Dec 7.
PMID: 21144850DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The patients without symptoms who refused follow-up endoscopy were regarded as having no recurrent ulcers. Because peptic ulcer may be asymptomatic, the cumulative number of recurrent peptic ulcer might be underestimated in both groups.
Results Point of Contact
- Title
- Dr. Ping-I Hsu
- Organization
- KaohsiungVGH
Study Officials
- STUDY CHAIR
Kwok-Hung Lai, MD
Kaohsiung Veterans General Hospital.
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief, Gastroenterology Division
Study Record Dates
First Submitted
June 7, 2010
First Posted
June 8, 2010
Study Start
August 1, 2008
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
September 9, 2015
Results First Posted
February 4, 2013
Record last verified: 2015-09