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

Sponsor
Amgen
Study ID
NCT07803679
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Evolocumab — DRUG
    Evolocumab will be provided as a single-dose, prefilled AI pen for fixed dose subcutaneous (SC) injection.
  • Routine Lipid Management — DRUG
    Routine lipid management therapies will be administered at the discretion of the investigator per SoC.
  • Autoinjector — DEVICE
    AI for SC injection of Evolocumab

Study Details

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).

Key Dates

First listed
Sep 4, 2026
Start date
Jan 31, 2027
Status verified
Sep 2026
Primary completion
Apr 30, 2029
Completion
Apr 30, 2029

Study Design

Enrollment
308 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Evolocumab and Routine Lipid Management
    Participants will receive Evolocumab via Autoinjector (AI) every 2 weeks (Q2W) plus routine lipid management.
  • Active Comparator: Routine Lipid Management
    Participants will receive routine lipid management per standard of care (SoC).

Primary Outcome Measure

Change in Non-Calcified Plaque (NCP) Volume from Baseline to Week 72 [ Time Frame: From Baseline to Week 72 ]

Central Contacts

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