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NOT YET RECRUITING
NCT07803679
PHASE4

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

Sponsor: Amgen

View on ClinicalTrials.gov

Summary

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).

Official title: A Phase 4, Open-label, Blinded Primary Endpoint, Randomized Multicenter Trial to Assess the Effectiveness of Evolocumab With Routine Lipid Management Compared With Routine Lipid Management Alone in Reducing the Plaque Burden in Patients With Subclinical Atheroma

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

308

Start Date

2027-01-31

Completion Date

2029-04-30

Last Updated

2026-09-21

Healthy Volunteers

No

Interventions

DRUG

Evolocumab

Evolocumab will be provided as a single-dose, prefilled AI pen for fixed dose subcutaneous (SC) injection.

DRUG

Routine Lipid Management

Routine lipid management therapies will be administered at the discretion of the investigator per SoC.

DEVICE

Autoinjector

AI for SC injection of Evolocumab