Effect of Evolocumab on Coronary Plaque Characteristics
Status:
Recruiting
Trial end date:
2024-02-01
Target enrollment:
Participant gender:
Summary
The aim of the study is to assess the effect of evolocumab on coronary plaque morphology
using intravascular imaging and gene expression analysis of peripheral blood mononuclear
cells (PBMC) in patients with stable CAD on maximally tolerated statin therapy. The study
combines multi-modality intravascular imaging approaches and transcriptomic based machine
learning algorithms to uncover molecular mechanisms responsible for the beneficial changes in
atherosclerotic lesions of patients treated with evolocumab. The primary end-points are the
changes from baseline to follow-up in (1) the minimal fibrous cap thickness (FCT) assessed by
optical coherence tomography (OCT) and (2) maxLCBI4mm assessed by near-infrared spectroscopy
(NIRS) after 26 weeks of evolocumab. The secondary endpoints are the changes in (1) the
maximal lipid arc, lipid length, lipid volume index, macrophage accumulation and
calcification by OCT; (2) PAV and TAV defined by intravascular ultrasound (IVUS) and (3)
Changes in PBMC gene expression.