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

Sponsor
Novartis Pharmaceuticals
Study ID
NCT06372925
Phase
PHASE4
Status
Recruiting
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Conditions

  • Plaque, Atherosclerotic

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date
Jul 9, 2024
Status verified
May 2026
Primary completion
Dec 30, 2026
Completion
Jan 26, 2027

Study Design

Enrollment
318 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Inclisiran and atorvastatin
    Inclisiran 284mg SC (at D1,D90,D270)+ 20mg atorvastatin PO
  • Active Comparator: atorvastatin
    20mg atorvastatin PO

Primary Outcome Measure

Change in percent atheroma volume (PAV) [ Time Frame: Up to 360 days ]

Central Contacts