NCT00944866

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2008

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 23, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

July 23, 2009

Status Verified

July 1, 2009

Enrollment Period

1.9 years

First QC Date

July 22, 2009

Last Update Submit

July 22, 2009

Conditions

Study Arms (2)

RA with drug

RA without drug

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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.

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

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