Sulfasalazine and Endothelial Function
Information source: Boston University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Artery Disease
Intervention: Sulfasalazine (Drug)
Phase: N/A
Status: Completed
Sponsored by: Boston University Official(s) and/or principal investigator(s):
Joseph A Vita, MD, Principal Investigator, Affiliation: Boston Medical Center
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.
Clinical Details
Official title: Effect of Sulfasalazine on Endothelial Function
Study design: Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment
Primary outcome: Brachial artery flow-mediated dilation
Secondary outcome: serum markers of inflammation
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Boston Medical Center, Boston, Massachusetts 02118, United States
Additional Information
Starting date: July 2003
Ending date: December 2007
Last updated: May 13, 2008
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