Adults 18 to 99, any sex, with Hypercholesterolemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Percent Atheroma Volume at Week 78Primary· Baseline and 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.
Group
Value
95% CI
Placebo
0.053
± 0.189
Evolocumab
-0.955
± 0.190
Change From Baseline in Total Atheroma Volume at Week 78Secondary· Baseline and 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.
Group
Value
95% CI
Placebo
-0.910
± 1.214
Evolocumab
-5.799
± 1.216
Percentage of Participants With Regression in Percent Atheroma VolumeSecondary· Baseline and 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.
Regression in PAV was defined as any reduction from baseline in PAV.
Group
Value
95% CI
Placebo
47.3
42.6 – 52.0
Evolocumab
64.3
59.6 – 68.7
Percentage of Participants With Regression in Total Atheroma VolumeSecondary· Baseline and 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.
Regression in TAV was defined as any reduction from baseline in TAV.
Group
Value
95% CI
Placebo
48.9
44.2 – 53.7
Evolocumab
61.5
56.7 – 66.0
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose of study drug until week 80.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06081153 — Mechanistic Clinical Trial of PCSK9 Inhibition for AAA
· EARLY_PHASE1
· not yet recruiting
NCT06858332 — Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia
· recruiting
NCT06284564 — A Phase II Study Bolstering Outcomes by Optimizing Immunotherapy Strategies With Evolocumab and Nivolumab in Patients Wi
· Phase 2
· active not recruiting
NCT06134635 — Short-term Effect of PCSK9 Inhibitor in Patients With Acute Ischemic Stroke
· unknown
NCT05974345 — In Silico Study Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Patients With Established C
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Amgen
Last refreshed: 20 February 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01813422.