Vascular Diseases
Conditions
Brief summary
The purpose of the study is to determine whether a p38 kinase inhibitor reduces inflammation in atherosclerotic plaque
Interventions
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* History of documented atherosclerosis * LDL between 70 and 130 mg/dL * Patients receiving stable low- to moderate-dose statin * BMI 18-37 kg/m² * Must be able to swallow tablets * Must be able to medically tolerate the procedures, contrast medium, and medications involved
Exclusion criteria
* Statin intolerance * Renal impairment (serum creatinine \> 1.5 mg/dL) * History of chronic viral hepatitis or other liver dysfunction * Major infection requiring hospitalization or receipt of IV antibiotics due to an infection within 2 months prior to initiation of study treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FDG-PET signal of the carotid and/or ascending aorta | at 4 and 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Inflammatory and thrombotic biomarkers | will be measured throughout the 12 weeks of treatment |
Countries
United States
Outcome results
None listed