Inflammation and Vascular Function in Atherosclerosis

Phase 2

Completed

• Conditions: Atherosclerosis
• Interventions: Drug: placebo; Drug: salsalate

• Registration Number: NCT00760019
• Lead Sponsor: Brigham and Women's Hospital

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.

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2008-09-24
• Study First Submitted QC: 2008-09-24
• Study First Posted: 2008-09-25
• Primary Completion: 2009-10
• Study Completion: 2011-02
• Results First Submitted: 2016-12-08
• Results First Submitted QC: 2017-02-22
• Status Verified: 2017-04
• Results First Posted: 2017-04-06
• Last Update Submitted: 2017-04-17
• Last Update Posted: 2017-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo first, then Salsalate	placebo	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.
Salsalate first, then Placebo	salsalate	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.

Primary Outcome Measures

Name	Time	Method
Flow-mediated, Endothelium-dependent Vasodilation	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.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States