Sulfasalazine and Endothelial Function
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sulfasalazine
Sponsored by
About this trial
This is an interventional basic science trial for Coronary Artery Disease
Eligibility 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
Sites / Locations
- Boston Medical Center
Outcomes
Primary Outcome Measures
Brachial artery flow-mediated dilation
Secondary Outcome Measures
serum markers of inflammation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00554203
Brief Title
Sulfasalazine and Endothelial Function
Official Title
Effect of Sulfasalazine on Endothelial Function
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Boston University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Sulfasalazine
Intervention Description
sulfasalazine 2 grams daily for 6 weeks
Primary Outcome Measure Information:
Title
Brachial artery flow-mediated dilation
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
serum markers of inflammation
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph A Vita, MD
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22496207
Citation
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.
Results Reference
derived
Learn more about this trial
Sulfasalazine and Endothelial Function
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