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Trial record 1 of 1 for:    NCT00471341
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Effect of Celecoxib on Markers of Vascular Inflammation

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ClinicalTrials.gov Identifier: NCT00471341
Recruitment Status : Completed
First Posted : May 9, 2007
Last Update Posted : September 19, 2011
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE May 7, 2007
First Posted Date  ICMJE May 9, 2007
Last Update Posted Date September 19, 2011
Study Start Date  ICMJE July 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2007)
Change in CRP
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2007)
  • Change in IL6
  • Change in TNF alpha
  • Change in BP
  • Change in indices of vascular function (FMD and vascular compliance)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Celecoxib on Markers of Vascular Inflammation
Official Title  ICMJE A Pilot Study to Determine the Effect of Celecoxib on Markers of Inflammation in Patients With Hypertension and Coronary Artery Disease
Brief Summary This study involves a drug called celecoxib, which is commonly prescribed for people with arthritis. Arthritis is caused by inflammation of the joints or tissues. Inflammation also occurs in the blood vessels that lead to your heart, and the purpose of this study is to see if celecoxib can reduce the blood vessel inflammation associated with high cholesterol and heart disease.
Detailed Description Chronic inflammation of the blood vessel wall is a hallmark of atherosclerosis. Elevated levels of low-density lipoprotein cholesterol (LDL-C), as well as blood pressure are known to be proinflammatory. Recent information suggests that acute ischemic events are associated with exacerbations in inflammation. Some data suggest that aspirin use is associated with suppression of markers of inflammation, and this response has been linked with improved outcome. Similarly, HMG Co-A Reductase inhibitors clearly reduce adverse outcomes in patients with atherosclerosis and recently, HMG Co-A Reductase inhibitor use has also been linked to reduction in inflammation. Due to the strong association of atherogenesis and plaque stability with inflammation, C-Reactive Protein (CRP), a marker of inflammation, has been evaluated as a potential tool for clinicians to assess cardiovascular risk, and has been found to be highly correlated. There is also evidence to suggest that cyclooxygenase 2 (COX-2) enzyme is expressed in plaque at regions which are vulnerable to rupture. Accordingly, this study is designed to investigate the potential reduction in vascular inflammation from a specific COX-2 inhibitor, celecoxib, as measured by a reduction from baseline of CRP, interleukin-6 (IL-6) and tumor necrosis factor - alpha (TNF-alpha). This is a double blind, placebo controlled pilot study in hypertensive patients with coronary artery disease and dyslipidemia, to evaluate the effect of celecoxib versus placebo on inflammatory markers. Patients will receive study drug for three months.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Hypertension and Coronary Artery Disease
Intervention  ICMJE
  • Drug: Celecoxib
  • Drug: placebo
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: May 8, 2007)
75
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age greater than or equal to 50 years old
  • Hypertension documented and treated according to the 6th report of the Joint National Committee on Detection and Evaluation of the treatment of high blood pressure (JNC VI)
  • Documented coronary artery disease, defined as classic stable angina pectoris, previous myocardial infarction (more than 1 month ago) or unstable angina (more than 1 month ago), abnormal coronary angiogram, or concordant abnormalities on two different types of stress tests
  • Dyslipidemia requiring medical therapy with HMG CoA Reductase inhibitors, and treated according to NCEP II guidelines for cholesterol lowering
  • Diabetes, if treated according to ADA guidelines for diabetes
  • Classic angina, if treated according to ACC/AHA guidelines for angina control
  • Therapy with an HMG CoA Reductase inhibitor for at least 3 months
  • Willingness to provide informed consent

Exclusion Criteria:

  • PUD
  • Coronary Artery Bypass Surgery or PTCA in the past 6 months
  • Active infection
  • Weight < 50Kg
  • History of a hematologic bleeding disorder
  • History of gastrointestinal bleeding
  • Allergy to aspirin or celecoxib or other NSAIDs or sulfonamides
  • Allergy or intolerance to HMG CoA Reductase inhibitor therapy
  • Stroke within 1 month of enrollment
  • History of a chronic inflammatory disease
  • History of asthma
  • History of hepatic disorder
  • Advanced renal disease (Serum Creatinine > 3mg/dl)
  • Anticipated need for therapy with NSAIDs within the 3 month period of the study
  • Chronic therapy (14 consecutive days) with any NSAID in the last 30 days
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00471341
Other Study ID Numbers  ICMJE 219-2001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Rhonda M Cooper-DeHoff, Pharm D University of Florida Faculty
PRS Account University of Florida
Verification Date May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP