Effect of Celecoxib on Markers of Vascular Inflammation

Hypertension and Coronary Artery Disease Clinical Trial

Official title:

A Pilot Study to Determine the Effect of Celecoxib on Markers of Inflammation in Patients With Hypertension and Coronary Artery Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00471341
• Other study ID #: 219-2001
• Status: Completed
• Phase: Phase 4
• First received: May 7, 2007
• Last updated: September 16, 2011
• Start date: July 2002
• Est. completion date: December 2004

Study information

• Verified date: May 2007
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Hypertension
• Hypertension and Coronary Artery Disease
• Inflammation
• Myocardial Ischemia

Intervention

Drug:
• Celecoxib

• placebo

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida
United States	University of Texas Health Science Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in CRP
Secondary	Change in IL6
Secondary	Change in TNF alpha
Secondary	Change in BP
Secondary	Change in indices of vascular function (FMD and vascular compliance)