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Effect of Celecoxib on Markers of Vascular Inflammation

Primary Purpose

Hypertension and Coronary Artery Disease

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Celecoxib

placebo

About this trial

This is an interventional treatment trial for Hypertension and Coronary Artery Disease focused on measuring arteriosclerosis, coronary disease, inflammation, COX-2 inhibition, hypertension

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Florida
University of Texas Health Science Center

Outcomes

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)

Full Information

NCT ID

NCT00471341

First Posted

May 7, 2007

Last Updated

September 16, 2011

Sponsor

University of Florida

Collaborators

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00471341

Brief Title

Effect of Celecoxib on Markers of Vascular Inflammation

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2007

Overall Recruitment Status

Completed

Study Start Date

July 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Florida

Collaborators

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension and Coronary Artery Disease

Keywords

arteriosclerosis, coronary disease, inflammation, COX-2 inhibition, hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

75 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Celecoxib

Intervention Type

Drug

Intervention Name(s)

placebo

Primary Outcome Measure Information:

Title

Change in CRP

Secondary Outcome Measure Information:

Title

Change in IL6

Title

Change in TNF alpha

Title

Change in BP

Title

Change in indices of vascular function (FMD and vascular compliance)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rhonda M Cooper-DeHoff, Pharm D

Organizational Affiliation

University of Florida Faculty

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Florida

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

Facility Name

University of Texas Health Science Center

City

Houston

State/Province

Texas

Country

United States

12. IPD Sharing Statement

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Effect of Celecoxib on Markers of Vascular Inflammation

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