Sulfasalazine and Endothelial Function

Completed · Not applicable

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT00554203

Run by

Boston University

People needed

60

Starts

2003-07-01

Expected to finish

2007-12-01

Last updated by the study team

2008-05-15

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• History of coronary artery disease

You may not qualify if…

• 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

Where it is running

• Boston Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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