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).
HeartFlow is the imaging vendor
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
308
Evolocumab will be provided as a single-dose, prefilled AI pen for fixed dose subcutaneous (SC) injection.
Routine lipid management therapies will be administered at the discretion of the investigator per SoC.
AI for SC injection of Evolocumab
Change in Non-Calcified Plaque (NCP) Volume from Baseline to Week 72
Time frame: From Baseline to Week 72
Change From Baseline in Low Attenuation Plaque Volume
Time frame: From Baseline to Week 72
Change From Baseline in Total Plaque Volume
Time frame: From Baseline to Week 72
Change From Baseline in Calcified Plaque Volume
Time frame: From Baseline to Week 72
Change From Baseline in Lumen Volume
Time frame: From Baseline to Week 72
Change From Baseline in Lesion-specific and nadir Coronary Computed Tomography Angiography (CCTA) derived Fractional Flow Reserve (FFRct)
Time frame: From Baseline to Week 72
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