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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Chung Hsing University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Chung Hsing University
ClinicalTrials.gov Identifier:
NCT00944866
First received: July 22, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

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
Arthritis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional

Further study details as provided by National Chung Hsing University:

Estimated Enrollment: 30
Study Start Date: March 2008
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
RA with drug
RA without drug

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Arthritis

Criteria

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: En-Pei Isabel Chiang, National Chung Hsing University
ClinicalTrials.gov Identifier: NCT00944866     History of Changes
Other Study ID Numbers: C07146
Study First Received: July 22, 2009
Last Updated: July 22, 2009
Health Authority: Taiwan: Institutional Review Board

Additional relevant MeSH terms:
Arthritis
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on June 17, 2013