Sulfasalazine and Endothelial Function
Effect of Sulfasalazine on Endothelial Function
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable coronary-artery-disease
Started Jul 2003
Typical duration for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2003
CompletedFirst Submitted
Initial submission to the registry
November 5, 2007
CompletedFirst Posted
Study publicly available on registry
November 6, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedMay 15, 2008
May 1, 2008
4.4 years
November 5, 2007
May 13, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Brachial artery flow-mediated dilation
6 weeks
Secondary Outcomes (1)
serum markers of inflammation
6 weeks
Interventions
sulfasalazine 2 grams daily for 6 weeks
Eligibility Criteria
You may qualify if:
- History of coronary artery disease
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Boston Medical Center
Boston, Massachusetts, 02118, United States
Related Publications (1)
Tabit CE, Holbrook M, Shenouda SM, Dohadwala MM, Widlansky ME, Frame AA, Kim BH, Duess MA, Kluge MA, Levit A, Keaney JF Jr, Vita JA, Hamburg NM. Effect of sulfasalazine on inflammation and endothelial function in patients with established coronary artery disease. Vasc Med. 2012 Apr;17(2):101-7. doi: 10.1177/1358863X12440117.
PMID: 22496207DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph A Vita, MD
Boston Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 5, 2007
First Posted
November 6, 2007
Study Start
July 1, 2003
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
May 15, 2008
Record last verified: 2008-05