Atherosclerotic Cardiovascular Disease
Conditions
Brief summary
The purpose of the study is to assess the effect of BMS-823778 on reducing atherosclerotic plaque inflammation
Interventions
DRUGBMS-823778
Capsules, Oral, 2mg, Once daily, 1 year
Capsules, Oral, 0mg, Once daily, 1 year
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Documented atherosclerotic cardiovascular disease or at high risk of cardiovascular event * On stable statin dose * Clinically stable at time of screening and randomization
Exclusion criteria
* Women of child bearing potential * Medical conditions that would impact the absorption of the study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effect of BMS-823778 versus placebo on carotids and/or ascending aortic will be measured by fluorodeoxyglucose (FDG) uptake in the index vessel as by positron emission tomography (PET) imaging | Day 168 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Structural changes in the arterial wall (absolute, percent change, and both, from baseline in four indices) | Day 364 | Structural changes in the arterial wall (absolute, percent change, and both, from baseline in four indices): total vessel area, wall area, wall thickness, and wall area/total vessel area ratio (normalized wall index), based on the average of the right and left carotids, measured by Magnetic Resonance Imaging (MRI) |
| Safety will be measured by adverse event, vital signs, electrocardiogram, physical examinations, clinical laboratory tests and Ferriman- Gallwey scores | Approximately up to 60 weeks | — |
Outcome results
None listed