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V-ACCELERATE: Inclisiran for Coronary Atherosclerotic Plaque in Acute Myocardial Infarction

NCT06372925Phase 4

Key facts

Status: Active, not recruiting
Start: Jul 2024
Primary completion: Dec 2026
Countries: 1
Sponsor: Novartis
Modality: Antisense DNA, Conjugated siRNA, MicroRNA (miRNA)

Drugs: inclisiran
Conditions: atherosclerosisacute myocardial infarction (AMI)hypercholesterolemia

Overview

Phase 4, randomised, open-label trial of inclisiran in atherosclerosis, acute myocardial infarction (AMI) and hypercholesterolemia (2 arms), sponsored by Novartis. Primary endpoint: Change in percent atheroma volume at 360 days. Started Jul 2024; status: active, not recruiting.

Design

2 arms

Study design: RandomizedOpen-label

Inclisiran and atorvastatin
Inclisiran 284mg SC (at D1, D90, D270) + 20mg atorvastatin PO
atorvastatin
20mg atorvastatin PO

Who it enrols

Adults aged 18-75 with acute myocardial infarction (STEMI/NSTEMI) planned for PCI, with elevated LDL-C and suitable target vessel for IVUS/OCT evaluation. Excludes patients with familial hypercholesterolemia, left main or three-vessel disease, severe hypertension, severe renal impairment, active liver disease, or prior PCSK9-targeted therapy.

Endpoints

Primary

Change in percent atheroma volume360 days

Secondary

Change in minimum fibrous cap thickness360 days
Change in mean minimum fibrous cap thickness of all images360 days
Change in normalized total atheroma volume360 days
Proportion of participants with progression, regression, or no change in PAV360 days
Change in Low-density Lipoprotein CholesterolDay 360
Change in Total CholesterolDay 360
Change in High-density Lipoprotein CholesterolDay 360
Change in non-High-density Lipoprotein CholesterolDay 360

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