Sulfasalazine and Endothelial Function

Boston University

Status

Completed

Conditions

Coronary Artery Disease

Treatments

Drug: Sulfasalazine

Study type

Interventional

Funder types

Other

Identifiers

NCT00554203

H-22844

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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