Sulfasalazine and Endothelial Function

Coronary Artery Disease Clinical Trial

Official title:

Effect of Sulfasalazine on Endothelial Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00554203
• Other study ID #: H-22844
• Status: Completed
• Phase: N/A
• First received: November 5, 2007
• Last updated: May 13, 2008
• Start date: July 2003
• Est. completion date: December 2007

Study information

• Verified date: May 2008
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Sulfasalazine
sulfasalazine 2 grams daily for 6 weeks

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brachial artery flow-mediated dilation		6 weeks
Secondary	serum markers of inflammation		6 weeks