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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 22, 2014