Phase 3 N=58 Randomized Quadruple-blind Treatment

Inflammation and Vascular Function in Atherosclerosis

Atherosclerosis

Bottom Line

View on ClinicalTrials.gov: NCT00760019 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2017

Primary outcome: Primary: Flow-mediated, Endothelium-dependent Vasodilation — 6.8; 8.7 percentage vasodilation

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: salsalate (Drug); placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Brigham and Women's Hospital
Primary completion: Oct 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Flow-mediated, Endothelium-dependent Vasodilation	6.8; 8.7	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00760019). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.