Sulfasalazine and Endothelial Function

• Sponsor: Boston University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00554203
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Duration (Months): 53
• Patients Per Site Per Month: 1.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Drug: Sulfasalazine	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Effect of Sulfasalazine on Endothelial Function
• Study Start Date: Jul 1, 2003
• Actual Primary Completion Date: Dec 1, 2007
• Actual Study Completion Date: Dec 1, 2007

Outcome Measures

Primary Outcome Measures

1. Brachial artery flow-mediated dilation [6 weeks]

Secondary Outcome Measures

1. serum markers of inflammation [6 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Boston Medical Center	Boston	Massachusetts	United States	02118

Sponsors and Collaborators

• Boston University

Investigators

• Principal Investigator: Joseph A Vita, MD, Boston Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00554203
• Other Study ID Numbers: H-22844
• First Posted: Nov 6, 2007
• Last Update Posted: May 15, 2008
• Last Verified: May 1, 2008

• Additional relevant MeSH terms: Coronary Artery Disease; Sulfasalazine

Study Results

No Results Posted as of May 15, 2008