This study will assess the effect of RO4607381, compared to placebo, on atherosclerotic plaque in patients with coronary heart disease (CHD) including patients with other CHD risk factors. After a pre-randomisation period during which positron emission tomography computed tomography (PET/CT) and MRI will be conducted, patients will be randomized to receive either RO4607381 600mg po daily, or placebo po daily. PET/CT and MRI scans will be taken at intervals during the study. The anticipated time on study treatment is 2 years, and the target sample size is 100 individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
130
600mg po daily for 24 months
po daily for 24 months
Unnamed facility
Jacksonville, Florida, United States
Unnamed facility
Royal Oak, Michigan, United States
Unnamed facility
Minneapolis, Minnesota, United States
Unnamed facility
Kansas City, Missouri, United States
Unnamed facility
New York, New York, United States
Unnamed facility
Statesville, North Carolina, United States
Unnamed facility
Cincinnati, Ohio, United States
Unnamed facility
Cincinnati, Ohio, United States
Unnamed facility
Cleveland, Ohio, United States
Unnamed facility
Houston, Texas, United States
...and 2 more locations
Percent Change From Baseline in Mean Wall Thickness
Time frame: 24 months
Change From Baseline in Target (Plaque) to Background (Blood) Ratio From an Index Vessel.
Time frame: 6 months
Change From Baseline in Vessel Magnetic Resonance (MR) Determined Compliance
Time frame: 6 months
Change From Baseline in Vessel MR Determined Plaque Anatomy
Time frame: Up to 24 months
Blood Lipids,Lipoproteins
Time frame: Throughout study
Biomarkers
Time frame: Up to 24 months
CHD, Major Coronary Events, Adverse Events (AEs), Lab Parameters, Blood Pressure
Time frame: Throughout study
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