Expired Study
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Boston, Massachusetts 02118


Purpose:

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.


Criteria:

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 is Available At:


Original ID:

H-22844


NCT ID:

NCT00554203


Secondary ID:


Study Acronym:


Brief Title:

Sulfasalazine and Endothelial Function


Official Title:

Effect of Sulfasalazine on Endothelial Function


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Boston University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Cros


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

60


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Joseph A Vita, MD
Principal Investigator
Boston Medical Center

Study Dates

Start Date:July 2003
Completion Date:December 2007
Completion Type:Actual
Primary Completion Date:December 2007
Primary Completion Type:Actual
Verification Date:May 2008
Last Changed Date:May 13, 2008
First Received Date:November 5, 2007

Study Outcomes

Outcome Type:Secondary Outcome
Measure:serum markers of inflammation
Time Frame:6 weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Brachial artery flow-mediated dilation
Time Frame:6 weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Sulfasalazine
Description:sulfasalazine 2 grams daily for 6 weeks

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Boston University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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