Effect of Celecoxib on Markers of Vascular Inflammation

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: NCT00471341
Recruitment Status : Completed
First Posted : May 9, 2007
Last Update Posted : September 19, 2011
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment Phase
Hypertension and Coronary Artery Disease Drug: Celecoxib Drug: placebo Phase 4

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 : Interventional  (Clinical Trial)
Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Pilot Study to Determine the Effect of Celecoxib on Markers of Inflammation in Patients With Hypertension and Coronary Artery Disease
Study Start Date : July 2002
Actual Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Celecoxib

Primary Outcome Measures :
  1. Change in CRP

Secondary Outcome Measures :
  1. Change in IL6
  2. Change in TNF alpha
  3. Change in BP
  4. Change in indices of vascular function (FMD and vascular compliance)

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00471341

United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
United States, Texas
University of Texas Health Science Center
Houston, Texas, United States
Sponsors and Collaborators
University of Florida
Principal Investigator: Rhonda M Cooper-DeHoff, Pharm D University of Florida Faculty

Responsible Party: University of Florida Identifier: NCT00471341     History of Changes
Other Study ID Numbers: 219-2001
First Posted: May 9, 2007    Key Record Dates
Last Update Posted: September 19, 2011
Last Verified: May 2007

Keywords provided by University of Florida:
coronary disease
COX-2 inhibition

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Heart Diseases
Arterial Occlusive Diseases
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents