This study will evaluate whether low-density lipoprotein (LDL-C) lowering with evolocumab (AMG 145) results in greater change from baseline in percent atheroma volume (PAV) at week 78 than placebo in adults with coronary artery disease taking lipid lowering therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
970
Administered by subcutaneous injection
Administered by subcutaneous injection
Change From Baseline in Percent Atheroma Volume at Week 78
Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. The extent of atherosclerosis was expressed as percent atheroma volume (PAV) in a ≥ 40 mm segment of one targeted (imaged) coronary artery, calculated as the percentage of the total vessel volume occupied by atheroma.
Time frame: Baseline and week 78
Change From Baseline in Total Atheroma Volume at Week 78
Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. Total atheroma volume (TAV) in a ≥ 40 mm segment of the targeted coronary artery was calculated as the average plaque area over the number of images that were evaluated by IVUS multiplied by the median vessel length to compensate for differences in segment length between participants.
Time frame: Baseline and week 78
Percentage of Participants With Regression in Percent Atheroma Volume
Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. The extent of atherosclerosis was expressed as percent atheroma volume (PAV) in a ≥ 40 mm segment of one targeted (imaged) coronary artery, calculated as the percentage of the total vessel volume occupied by atheroma. Regression in PAV was defined as any reduction from baseline in PAV.
Time frame: Baseline and week 78
Percentage of Participants With Regression in Total Atheroma Volume
Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. Total atheroma volume (TAV) in a ≥ 40 mm segment of the targeted coronary artery was calculated as the average plaque area over the number of images that were evaluated by IVUS multiplied by the median vessel length to compensate for differences in segment length between participants. Regression in TAV was defined as any reduction from baseline in TAV.
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Research Site
Huntsville, Alabama, United States
Research Site
Mobile, Alabama, United States
Research Site
Little Rock, Arkansas, United States
Research Site
La Jolla, California, United States
Research Site
La Jolla, California, United States
Research Site
Long Beach, California, United States
Research Site
Newport Beach, California, United States
Research Site
Orange, California, United States
Research Site
San Diego, California, United States
Research Site
Santa Monica, California, United States
...and 216 more locations
Time frame: Baseline and week 78