Status:
COMPLETED
Effect of Celecoxib on Markers of Vascular Inflammation
Lead Sponsor:
University of Florida
Collaborating Sponsors:
Pfizer
Conditions:
Hypertension and Coronary Artery Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE4
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...
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 proinflammator...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
End Date :
December 1 2004
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00471341
Start Date
July 1 2002
End Date
December 1 2004
Last Update
September 19 2011
Active Locations (2)
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1
University of Florida
Gainesville, Florida, United States, 32610
2
University of Texas Health Science Center
Houston, Texas, United States