NCT06372925

Intravascular Imaging Study of the Effect of Inclisiran on Plaque in Patients With Acute Myocardial Infarction

A Multi-Center, Randomized, Open-label, Parallel, Controlled Phase Ⅳ Clinical Trial to Evaluate the Effect of Inclisiran on Coronary Atherosclerotic Plaque in Patients With Acute Myocardial Infarction and Elevated Low-density Lipoprotein Cholesterol

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 334 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluate the effect of Inclisiran on coronary atherosclerosis using intravascular ultrasound (IVUS) and optical coherence tomography (OCT) in patients with acute myocardial infarction and elevated low-density lipoprotein cholesterol (LDL-C).

Detailed description

This study will be a multi-center, randomized, parallel-group, open-label, phase 4 study. Participants will be Chinese adults diagnosed with new-onset STEMI/NSTEMI and elevated LDL-C (LDL-C \> 1.8 mmol/L if on stable dose of statin (with or without ezetimibe) for ≥ 4 weeks; LDL-C \> 2.6 mmol/L if not on stable dose of statin (with or without ezetimibe) for ≥ 4 weeks). Participants will be 1:1 randomized to investigational group (Inclisiran 284mg + 20mg atorvastatin) or control group (20mg atorvastatin) for 360 days. Participants and investigator will be unblinded to the identity of the treatment from the time of randomization. Independent Review Committee (IRC) staff performing the study assessments (IVUS and OCT analysis) will be blinded to the identity of the treatment from the time of randomization until final database lock.

Conditions

• Plaque, Atherosclerotic

Interventions

Type	Name	Description
DRUG	atorvastatin	20mg atorvastatin PO
PROCEDURE	IVUS/OCT	performed the IVUS/OCT at baseline and Day 360
DRUG	inclisiran	Inclisiran 284mg SC

Timeline

• Start date: 2024-07-09
• Primary completion: 2026-12-30
• Completion: 2027-01-26
• First posted: 2024-04-18
• Last updated: 2026-04-14

Locations

20 sites across 1 country: China