Effect of Celecoxib on Markers of Vascular Inflammation

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00471341
First received: May 7, 2007
Last updated: September 16, 2011
Last verified: May 2007
  Purpose

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 Intervention Phase
Hypertension and Coronary Artery Disease
Drug: Celecoxib
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Change in CRP

Secondary Outcome Measures:
  • Change in IL6
  • Change in TNF alpha
  • Change in BP
  • Change in indices of vascular function (FMD and vascular compliance)

Estimated Enrollment: 75
Study Start Date: July 2002
Study Completion Date: December 2004
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00471341

Locations
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
Pfizer
Investigators
Principal Investigator: Rhonda M Cooper-DeHoff, Pharm D University of Florida Faculty
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00471341     History of Changes
Other Study ID Numbers: 219-2001
Study First Received: May 7, 2007
Last Updated: September 16, 2011
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 18, 2014