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

• Conditions: Arthritis

• Registration Number: NCT00944866
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Status Verified: 2009-07
• Study First Submitted: 2009-07-22
• Study First Submitted QC: 2009-07-22
• Last Update Submitted: 2009-07-22
• Study First Posted: 2009-07-23
• Last Update Posted: 2009-07-23
• Primary Completion: 2010-02
• Study Completion: 2010-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified