Effect of Celecoxib on Markers of Vascular Inflammation

NCT ID: NCT00471341

Last Updated: 2011-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-07-31
• Study Completion Date: 2004-12-31

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.

Conditions

Hypertension and Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Celecoxib

Intervention Type: DRUG

placebo

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rhonda M Cooper-DeHoff, Pharm D

Role: PRINCIPAL_INVESTIGATOR

University of Florida Faculty

Locations

University of Florida

Gainesville, Florida, United States

University of Texas Health Science Center

Houston, Texas, United States

Countries

United States

Other Identifiers

219-2001

Identifier Type: -

Identifier Source: org_study_id