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A Trial Assessing the Effectiveness of Evolocumab in Reducing the Plaque Burden in Participants With Subclinical Atheroma

StatusNot Yet Recruiting
PhasePhase 4
SponsorAmgen
Started2027-01-31
View on ClinicalTrials.gov ↗
The main aim of this trial is to demonstrate that Evolocumab plus routine lipid management is superior to routine lipid management alone in modifying plaque (non-calcified) volume as measured by Artificial Intelligence-enabled Quantitative Coronary Plaque Analysis (AI-QCPA) from Coronary Computed Tomography Angiography (CCTA).

Amendment history 7 changes detected by DataLookout

2026-09-11
Trial status changed: Withheld → Not Yet Recruiting
2026-09-11
Phase changed: not specified → Phase 4
2026-09-11
Primary endpoint(s) modified
2026-09-11
Enrollment changed: None → 308
2026-09-11
Sponsor changed: [Redacted] → Amgen
Was[Redacted]
NowAmgen
2026-09-11
Trial arms changed: 0 → 2
2026-09-11
Interventions modified
Trial Details
NCT Number NCT07803679
Lead Sponsor Amgen
Conditions Coronary Artery Disease, Hypercholesterolemia, Atheroma, Atherosclerotic Plaque
Enrollment 308 participants
Start Date 2027-01-31
Primary Completion 2029-04-30 (estimated)
Study Completion 2029-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-10