Coronary Artery DiseaseNCT00554203
Sulfasalazine and Endothelial Function
A study testing Sulfasalazine in people with Coronary Artery Disease, run by Boston University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Sulfasalazine
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to Dec 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of coronary artery disease
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Sulfasalazine on Endothelial Function
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.
- Conditions
- Coronary Artery Disease
- Being tested
- Sulfasalazine
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SulfasalazineDrug
sulfasalazine 2 grams daily for 6 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachial artery flow-mediated dilation
Measured: 6 weeks
Secondary outcomes (1)
serum markers of inflammation
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2007 (estimated)
- Study startJul 2003
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Investigators
- Joseph A Vita, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00554203
- Sponsor's protocol ID
- H-22844
- Status last verified
- May 2008
- First submitted
- 5 Nov 2007
- Last updated
- 15 May 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22496207
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sulfasalazine on Endothelial Function
- ClinicalTrials.gov ID
- NCT00554203
- Acronym / sponsor ID
- H-22844
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Study start
- Jul 2003
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 6 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- History of coronary artery disease
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sulfasalazinesulfasalazine 2 grams daily for 6 weeks | Drug | – |
Primary outcome
Brachial artery flow-mediated dilation
Time frame: 6 weeks
1 secondary outcome
serum markers of inflammation
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2008.
- Derived from this study: PubMed 22496207Tabit 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.
Related trials for Coronary Artery Disease
Recruiting
Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)
Coronary Artery Disease, High Risk Percutaneous Coronary Intervention
Active, not recruitingObservational study
Post-Induction Low Cardiac Output Syndrome in Coronary Artery Bypass Graft Surgery
Cardiac Output, Low, Coronary Arterial Disease
RecruitingPhase 3
A Clinical Trial To Investigate The Effect Of EA-230 On Hospital Length Of Stay In Patients With Coronary Artery Disease (CAD) Undergoing Coronary Artery Bypass Grafting (CABG) Surgery.
Coronary Artery Disease (CAD), Coronary Artery Bypass Graft Surgery(CABG)
Enrolling by invitationObservational study
Simultaneous Measurement of EpicArdial and Microvascular ResisTance Via Angiographic FLOW Study
Non-obstructive Coronary Disease, Acute or Chronic Coronary Artery Disease
Recruiting
Aggressive Lipid Lowering Therapy in ICI-Treated Melanoma
Melanoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph A Vita, MD principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sulfasalazine in people with Coronary Artery Disease, run by Boston University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brachial artery flow-mediated dilation (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00554203, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2008.