Sulfasalazine and Endothelial Function - Full Text View

Sponsor:	Boston University
Information provided by:	Boston University
ClinicalTrials.gov Identifier:	NCT00554203

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:	Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment
Official Title:	Effect of Sulfasalazine on Endothelial Function

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Sulfasalazine

U.S. FDA Resources

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:

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

Study ID Numbers:	H-22844
Study First Received:	November 5, 2007
Last Updated:	May 13, 2008
ClinicalTrials.gov Identifier:	NCT00554203 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Arterial Occlusive Diseases
Anti-Infective Agents
Heart Diseases
Myocardial Ischemia
Sulfasalazine
Physiological Effects of Drugs
Gastrointestinal Agents
Vascular Diseases
Arteriosclerosis
Pharmacologic Actions

Coronary Disease
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents
Coronary Artery Disease

ClinicalTrials.gov processed this record on November 27, 2009