Effects of Cox-II Inhibitor on Biochemical Markers in Cardiovascular-related Adverse Effects
1 other identifier
observational
30
0 countries
N/A
Brief Summary
The selective cyclooxygenase-2 (COX-2) inhibitors have been associated with increased cardiovascular risk. The goal of the present study is to investigate the impacts of COX-2 inhibitors on biochemical indices in cardiovascular disease. As the reviewer suggested, the investigators propose to study the effects of Cox-II inhibitor using experimentally induced hyperlipidemic rats. Plasma total cholesterol, LDL and triglyceride concentrations will be determined before and after animals treated with cyclooxygenase-2 (COX-2) inhibitors. Biochemical markers related to cardiovascular events including prostaglandin I2, thromboxaneA2 and others will also be investigated. The investigators will also investigate these biochemical markers in patients taking Celecoxib and NSAIDs. The investigators hope these studies will reveal clinically useful biochemical markers for cardiovascular events in patients taking Cox-II inhibitor.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2008
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
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 22, 2009
CompletedFirst Posted
Study publicly available on registry
July 23, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedJuly 23, 2009
July 1, 2009
1.9 years
July 22, 2009
July 22, 2009
Conditions
Study Arms (2)
RA with drug
RA without drug
Eligibility Criteria
Arthritis
You may qualify if:
- Male/female age \>18
- Clinical diagnosed of arthritis
You may not qualify if:
- Must not be pregnant/breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Chang HY, Tang FY, Chen DY, Chih HM, Huang ST, Cheng HD, Lan JL, Chiang EP. Clinical use of cyclooxygenase inhibitors impairs vitamin B-6 metabolism. Am J Clin Nutr. 2013 Dec;98(6):1440-9. doi: 10.3945/ajcn.113.064477. Epub 2013 Oct 23.
PMID: 24153347DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 22, 2009
First Posted
July 23, 2009
Study Start
March 1, 2008
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
July 23, 2009
Record last verified: 2009-07