Effects of Cox-II Inhibitor on Biochemical Markers in Cardiovascular-related Adverse Effects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00944866
Recruitment Status : Unknown
Verified July 2009 by National Chung Hsing University.
Recruitment status was:  Active, not recruiting
First Posted : July 23, 2009
Last Update Posted : July 23, 2009
Information provided by:
National Chung Hsing University

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.

Condition or disease

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Study Start Date : March 2008
Estimated Primary Completion Date : February 2010
Estimated Study Completion Date : February 2010

RA with drug
RA without drug

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Inclusion Criteria:

  • Male/female age >18
  • Clinical diagnosed of arthritis

Exclusion Criteria:

  • Must not be pregnant/breastfeeding
  • Other conditions may lead to exclusion from the trial (e.g. Diabetes mellitus, malignant melanoma, cardiac conduction disorders, hepatic/renal insufficiency.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: En-Pei Isabel Chiang, National Chung Hsing University Identifier: NCT00944866     History of Changes
Other Study ID Numbers: C07146
First Posted: July 23, 2009    Key Record Dates
Last Update Posted: July 23, 2009
Last Verified: July 2009