Clinical trial NCT00570752: Efficacy Study of p38 Kinase Inhibitor to Treat Patients With Atherosclerosis
Official title: A 12-Week, Randomized, Semi Double-Blinded Study Evaluating the Effects of Daily Oral High-Dose Atorvastatin or BMS-582949 on Atherosclerotic Plaque Inflammation as Determined by FDG-PET in High Risk Atherosclerotic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vascular Diseases
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2007-12-11
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine whether a p38 kinase inhibitor reduces inflammation in atherosclerotic plaque


Eligibility criteria: 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

Primary outcomes:
measure: FDG-PET signal of the carotid and/or ascending aorta
timeFrame: at 4 and 12 weeks
Secondary outcomes:
measure: Inflammatory and thrombotic biomarkers
timeFrame: will be measured throughout the 12 weeks of treatment
Other outcomes:
Locations:
city: Chiefland
country: United States
facility: Southeast Clinical Research, Llc
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center For Clinical Research - Univ Campus
state: Florida
city: Tampa
country: United States
facility: Florida Cardiovascular Institute
state: Florida
city: Indianapolis
country: United States
facility: Phillip D. Toth, Md
state: Indiana
city: Louisville
country: United States
facility: L-Marc Research Center
state: Kentucky
city: Madisonville
country: United States
facility: Commonwealth Biomedical Research, Llc
state: Kentucky
city: Boston
country: United States
facility: Mgh Cardiac Mr Pet Ct Program
state: Massachusetts
city: Troy
country: United States
facility: Troy Internal Medince Pc/Research
state: Michigan
city: Edina
country: United States
facility: Radiant Research, Inc.
state: Minnesota
city: New York
country: United States
facility: Mount Sinai School Of Medicine Imaging Science Laboratories
state: New York
city: Statesville
country: United States
facility: The Lipid Center
state: North Carolina
city: Cincinnati
country: United States
facility: Metabolic And Atherosclerosis Research Center
state: Ohio
city: Cincinnati
country: United States
facility: Sterling Research Group
state: Ohio
city: Philadelphia
country: United States
facility: Hospital Of The University Of Pennsylvania
state: Pennsylvania
city: Dallas
country: United States
facility: Radiant Research, Inc.
state: Texas
city: Houston
country: United States
facility: Baylor College Of Medicine
state: Texas
city: Mc Allen
country: United States
facility: Mcallen Heart Clinic
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Emami H, Vucic E, Subramanian S, Abdelbaky A, Fayad ZA, Du S, Roth E, Ballantyne CM, Mohler ER, Farkouh ME, Kim J, Farmer M, Li L, Ehlgen A, Langenickel TH, Velasquez L, Hayes W, Tawakol A. The effect of BMS-582949, a P38 mitogen-activated protein kinase (P38 MAPK) inhibitor on arterial inflammation: a multicenter FDG-PET trial. Atherosclerosis. 2015 Jun;240(2):490-6. doi: 10.1016/j.atherosclerosis.2015.03.039. Epub 2015 Mar 28.