Effect of Celecoxib on Markers of Vascular Inflammation

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Collaborator: Pfizer
• Treatments: Celecoxib

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