Sulfasalazine and Endothelial Function

Effect of Sulfasalazine on Endothelial Function

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00554203

Enrollment

Registered

2007-11-06

Start date

2003-07-31

Completion date

2007-12-31

Last updated

2008-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

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.

Interventions

DRUGSulfasalazine

sulfasalazine 2 grams daily for 6 weeks

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Brachial artery flow-mediated dilation	6 weeks

Secondary

Measure	Time frame
serum markers of inflammation	6 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026