To evaluate the effect of evolocumab on fibrous cap thickness (FCT) in participants with non-ST-elevation acute coronary syndrome (NSTE-ACS) who are taking maximally tolerated statin therapy.
This study seeks to identify morphologic changes, such as increase in FCT in atherosclerotic plaques associated with treatment with evolocumab and maximally tolerated statin therapy with or without additional lipid-modifying medication in patients presenting with NSTE-ACS using optical coherence tomography (OCT; primary, secondary, and exploratory endpoints).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
164
Participants will receive evolocumab (AMG 145) subcutaneous monthly.
Participants will receive matching placebo subcutaneous monthly.
high-intensity statin treatment with atorvastatin ≥ 40 mg daily or equivalent as background therapy Investigators will up-titrate statin therapy to the maximally tolerated dose, in accordance with local guidelines, prior to randomization.
Absolute Change From Baseline in Minimum FCT
Absolute change from baseline in minimum FCT in a matched segment of artery as determined by OCT. Minimum FCT for a participant is defined as the minimum of all minimum FCT measurements within each individual frame across all frames of that participant. Higher value of FCT indicates a better situation.
Time frame: Baseline, week 50
Percent Change From Baseline in Minimum FCT
Percent change from baseline in minimum FCT in a matched segment of artery as determined by OCT. Minimum FCT for a participant is defined as the minimum of all minimum FCT measurements within each individual frame across all frames of that participant. Higher value of FCT indicates a better situation.
Time frame: Baseline, week 50
Absolute Change From Baseline in Mean Minimum FCT
Absolute change from baseline in mean minimum FCT for all images assessed in an individual participant as determined by OCT. Minimum FCT for a participant is defined as the minimum of all minimum FCT measurements within each individual frame across all frames of that participant. Higher value of FCT indicates a better situation.
Time frame: Baseline, week 50
Absolute Change From Baseline in the Maximum Lipid Arc
Absolute change from baseline in the maximum lipid arc in a matched segment of artery as determined by OCT. Lower value of lipid arc indicates a better situation.
Time frame: Baseline, week 50
Absolute Change From Baseline in Minimum FCT in Lipid Rich Plaques
Absolute change from baseline in minimum FCT in lipid rich plaques as determined by OCT. Lipid rich plaques are defined as minimum FCT less than 120 μm and lipid arc greater than 90° in at least 3 consecutive images as determined by OCT. Higher value of FCT indicates a better situation
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University of California at Los Angeles
Los Angeles, California, United States
Medstar Heart and Vascular Institute
Washington D.C., District of Columbia, United States
Midwest Cardiovascular Research And Education Foundation
Elkhart, Indiana, United States
Saint Louis University Hospital
St Louis, Missouri, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Monash Medical Centre
Clayton, Victoria, Australia
The Northern Hospital
Epping, Victoria, Australia
...and 23 more locations
Time frame: Baseline, week 50
Absolute Change From Baseline in Maximum Lipid Arc in Lipid Rich Plaques
Absolute change from baseline in maximum lipid arc in lipid rich plaques. Lipid rich plaques are defined as minimum FCT less than 120 μm and lipid arc greater than 90° in at least 3 consecutive images as determined by OCT. Lower value of lipid arc indicates a better situation.
Time frame: Baseline, week 50
Absolute Change From Baseline in Lipid Core Length in Lipid Rich Plaques
Absolute change from baseline in lipid core length in lipid rich plaques. Lipid rich plaques are defined as minimum FCT less than 120 μm and lipid arc greater than 90° in at least 3 consecutive images as determined by OCT. Lower value of lipid core length indicates a better situation.
Time frame: Baseline, week 50