search
Back to results

Sulfasalazine and Endothelial Function

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sulfasalazine
Sponsored by
Boston University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional basic science trial for Coronary Artery Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Boston Medical Center

Outcomes

Primary Outcome Measures

Brachial artery flow-mediated dilation

Secondary Outcome Measures

serum markers of inflammation

Full Information

First Posted
November 5, 2007
Last Updated
May 13, 2008
Sponsor
Boston University
search

1. Study Identification

Unique Protocol Identification Number
NCT00554203
Brief Title
Sulfasalazine and Endothelial Function
Official Title
Effect of Sulfasalazine on Endothelial Function
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Boston University

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Sulfasalazine
Intervention Description
sulfasalazine 2 grams daily for 6 weeks
Primary Outcome Measure Information:
Title
Brachial artery flow-mediated dilation
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
serum markers of inflammation
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph A Vita, MD
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22496207
Citation
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.
Results Reference
derived

Learn more about this trial

Sulfasalazine and Endothelial Function

We'll reach out to this number within 24 hrs