NCT04710368

Effect of Evolocumab on Coronary Plaque Characteristics

Effect of Evolocumab on Coronary Plaque Characteristics: a Multimodality Imaging Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: Annapoorna Kini · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The single center single arm study will be performed in the Cardiac Catheterization laboratory of the Mount Sinai Hospital, New York, NY. After informed consent, patients undergoing clinically indicated elective PCI with a non-obstructive lesion and optimal background statin therapy will be eligible screening. Non-obstructive lesions (30-50% stenosis) identified by angiography in a non-culprit vessel with lipid-rich plaque will be studied. Subjects will receive evolocumab (Repatha) 140 mg subcutaneously every 2 weeks for 26 weeks. Serial NIRS/IVUS and OCT imaging will be performed in the non-obstructive lesions, first during PCI and subsequently after 26 weeks. A total of 25ml of blood will be drawn from the sheath during angiography for transcriptomic profiling of PBMC.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	Evolocumab Injections	Administered on day 1 (the day of the first treatment) and through week 26 with a personal injector or prefilled auto injector/pens.

Timeline

• Start date: 2021-05-04
• Primary completion: 2022-10-28
• Completion: 2023-11-06
• First posted: 2021-01-14
• Last updated: 2023-11-18
• Results posted: 2023-05-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study