Sulfasalazine and Endothelial Function

Not Applicable

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT00554203
• Lead Sponsor: Boston University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-07
• Study First Submitted: 2007-11-05
• Study First Submitted QC: 2007-11-05
• Study First Posted: 2007-11-06
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-13
• Last Update Posted: 2008-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Brachial artery flow-mediated dilation	6 weeks

Secondary Outcome Measures

Name	Time	Method
serum markers of inflammation	6 weeks

Trial Locations

Locations (1)

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States