Sulfasalazine and Endothelial Function

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston University
• Treatments: Sulfasalazine

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