Inflammation and Vascular Function in Atherosclerosis
Overview
- Phase
- Phase 2
- Intervention
- salsalate
- Conditions
- Atherosclerosis
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- Flow-mediated, Endothelium-dependent Vasodilation
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose of this study is to determine whether reducing inflammation in blood vessels with an aspirin-like drug called salsalate will improve blood vessel function.
Detailed Description
To test the hypothesis that inhibition of I \[kappa\] B kinase \[beta\] (IĸKβ), an inflammatory mediator, by high dose salsalate, will restore insulin-mediated endothelium-dependent vasodilation in subjects with atherosclerosis.
Investigators
Joshua A. Beckman, MD
MD
Brigham and Women's Hospital
Eligibility Criteria
Inclusion Criteria
- •Non-smoking adult subjects with known atherosclerosis
Exclusion Criteria
- •Uncontrolled hypertension (\> 140/90 mmHg)
- •Untreated hypercholesterolemia (LDL \> 160 mg/dL)
- •Diabetes mellitus
- •Alanine Aminotransferase \> 150
- •Creatinine \> 1.4 mg/dL
- •Concommitant use of warfarin
Arms & Interventions
Salsalate first, then Placebo
In this crossover study, this group was randomly allocated therapy with salsalate first, a 4 week washout, then 4 weeks of placebo therapy in a double-blinded fashion.
Intervention: salsalate
Placebo first, then Salsalate
In this crossover study, this group was randomly allocated therapy with placebo first, a 4 week washout, then 4 weeks of salsalate therapy in a double-blinded fashion.
Intervention: placebo
Outcomes
Primary Outcomes
Flow-mediated, Endothelium-dependent Vasodilation
Time Frame: Upon completion of 4 weeks of salsalate and placebo treatment
Flow-mediated, endothelium-dependent vasodilation (percentage increase in brachial artery diameter after a 5 minute ischemic stimulus) measured at the end of placebo treatment and end of salsalate treatment were compared.