At a glance
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An Open Label Safety and Efficacy Trial of Fenofibrate in Persons With SCI
In Brief
A Phase 3 clinical trial evaluating Fenofibrate and No intervention for Spinal Cord Injury and Dyslipidemia. Completed, enrolled 23 participants across 2 sites.
Detailed Summary
Cardiovascular disease-related morbidity in persons with spinal cord injury (SCI) occurs earlier in life, at a greater prevalence than that of the general population, and is the primary cause of death after the first year of injury. During the chronic phase of SCI, a characteristic dyslipidemia emerges, which is characterized by low serum high density lipoprotein cholesterol (HDL-C) concentrations, with values often qualifying to be an independent risk factor for coronary artery disease, and elevations in serum triglycerides (TG). Serum low density lipoprotein cholesterol concentrations in those with SCI are usually similar to those of the general population. The current proposal in persons with SCI aims to determine the safety and efficacy of short-term fenofibrate treatment, an anti-lipid medication whose primary action lowers serum TG and raises serum HDL-C levels.
Study Details
Timeline
Interventions
Fenofibrate is a peroxisome proliferator-activated receptor alpha agonist that is demonstrated to reduce triglyceride concentrations in the blood.
A cohort of participants will be randomized to receive no study drug, but will engage in study encounters.