Sulfasalazine and Endothelial Function - Tabular View

Tracking Information

First Received Date ^ICMJE

November 5, 2007

Last Updated Date

May 13, 2008

Start Date ^ICMJE

July 2003

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Brachial artery flow-mediated dilation [ Time Frame: 6 weeks ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00554203 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

serum markers of inflammation [ Time Frame: 6 weeks ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Sulfasalazine and Endothelial Function

Official Title ^ICMJE

Effect of Sulfasalazine on Endothelial Function

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment

Condition ^ICMJE

Coronary Artery Disease

Intervention ^ICMJE

Drug: Sulfasalazine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

December 2007

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00554203

Responsible Party

Study ID Numbers ^ICMJE

H-22844

Study Sponsor ^ICMJE

Boston University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Joseph A Vita, MD

Boston Medical Center

Information Provided By

Boston University

Verification Date

May 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP