Sulfasalazine and Endothelial Function

May 13, 2008 updated by: Boston University

Effect of Sulfasalazine on Endothelial Function

Experimental studies suggest that systemic inflammation leads to endothelial dysfunction and atherosclerosis. This study will examine the effects of the anti-inflammatory drug sulfasalazine on endothelial function in patients with coronary artery disease. Subjects will be treated with sulfasalazine or to placebo for six weeks. After a two-week rest period, subjects will cross over to the alternative treatment. Endothelium-dependent flow-mediated dilation of the brachial artery will be studied before and after each drug. We hypothesize that anti-inflammatory therapy will reverse endothelial dysfunction in patients with coronary artery disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • History of coronary artery disease

Exclusion Criteria:

  • G6PD deficiency defined by red blood cell G6PD activity assay
  • Sulfa allergy
  • Aspirin allergy
  • Allergy to furosemide (lasix), hydrochlorthiazide, sulfonylureas, acetazolamide (Diamox) or other carbonic anhydrase inhibitors
  • SGOT, SGPT, alkaline phosphatase, total bilirubin greater than 2 times the upper limit of normal
  • WBC less than 4.0 or greater than 11.0 K/UL
  • Platelet count less than 150 K or greater than 450K
  • Hematocrit less than 30% 7
  • Serum creatinine greater than 1.5 mg/dl
  • Unstable angina or acute MI within 2 weeks
  • Warfarin treatment
  • Immunosuppressive treatment (methotrexate, cyclosporine, etc.)
  • Digoxin treatment
  • Phenytoin (Dilantin) treatment
  • Methenamine (Mandelamine, Urex) treatment
  • Probenecid or sulfinpyrazone (Anturane, Aprazone) treatment
  • Porphyria
  • Symptomatic GI obstruction
  • GU obstruction (not including clinical evidence of benign prostatic hypertrophy)
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Brachial artery flow-mediated dilation
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
serum markers of inflammation
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

November 5, 2007

First Submitted That Met QC Criteria

November 5, 2007

First Posted (Estimate)

November 6, 2007

Study Record Updates

Last Update Posted (Estimate)

May 15, 2008

Last Update Submitted That Met QC Criteria

May 13, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-22844

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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