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Sulfasalazine and Endothelial Function

NCT ID: NCT00554203

Last Updated: 2008-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2007-12-31

Brief Summary

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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

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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Sulfasalazine

sulfasalazine 2 grams daily for 6 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston University

OTHER

Sponsor Role lead

Principal Investigators

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Joseph A Vita, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

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Boston Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Tabit CE, Holbrook M, Shenouda SM, Dohadwala MM, Widlansky ME, Frame AA, Kim BH, Duess MA, Kluge MA, Levit A, Keaney JF Jr, Vita JA, Hamburg NM. Effect of sulfasalazine on inflammation and endothelial function in patients with established coronary artery disease. Vasc Med. 2012 Apr;17(2):101-7. doi: 10.1177/1358863X12440117.

Reference Type DERIVED
PMID: 22496207 (View on PubMed)

Other Identifiers

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H-22844

Identifier Type: -

Identifier Source: org_study_id