Sulfasalazine and Endothelial Function

This study has been completed.
Sponsor:
Information provided by:
Boston University
ClinicalTrials.gov Identifier:
NCT00554203
First received: November 5, 2007
Last updated: May 13, 2008
Last verified: May 2008
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Drug: Sulfasalazine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Sulfasalazine on Endothelial Function

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • Brachial artery flow-mediated dilation [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • serum markers of inflammation [ Time Frame: 6 weeks ]

Estimated Enrollment: 60
Study Start Date: July 2003
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Sulfasalazine
    sulfasalazine 2 grams daily for 6 weeks
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00554203

Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
Investigators
Principal Investigator: Joseph A Vita, MD Boston Medical Center
  More Information

No publications provided by Boston University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00554203     History of Changes
Other Study ID Numbers: H-22844
Study First Received: November 5, 2007
Last Updated: May 13, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sulfasalazine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Anti-Infective Agents
Gastrointestinal Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014