Phase 3
N=23
Fenofibrate Treatment in SCI
Spinal Cord Injury · Dyslipidemia
Bottom Line
View on ClinicalTrials.gov: NCT02455336 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Triglyceride Concentration (Percent Change From Baseline) — -40; -2 percent change from baseline
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fenofibrate (Drug); No intervention (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Triglyceride Concentration (Percent Change From Baseline) |
-40; 7 | — |
| SECONDARY Triglyceride Concentration (Percent Change From Baseline) |
-40; 7 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Male or female, age 21 to 69;
- Chronic (e.g., duration of injury at least 6 months), stable SCI (regardless of level of neurological lesion);
- American Spinal Injury Association Impairment Scale (AIS) designation of A, B or C; and
- TG concentration 135 mg/dl (paraplegia) or 115 mg/dl (tetraplegia).
Exclusion Criteria
- Acute illness or infection;
- Reduced kidney function (by glomerular filtration rate (GFR 126 mg/dl.
Data sourced from ClinicalTrials.gov (NCT02455336). 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.