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

NCT06372925 | Recruiting Phase 4

• 1 other identifier: CKJX839A1CN04
• Study Type: interventional
• Target: 334
• Locations: 1 country
• Sites: 20

Brief 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).

Conditions

Plaque, Atherosclerotic

Keywords

Acute myocardial infarction,; Atherosclerotic plaque,; Inclisiran,; IVUS,; OCT,; PCI

Outcome Measures

Primary Outcomes (1)

• Change in percent atheroma volume (PAV)

  Change in PAV assessed by intravascular ultrasound (IVUS) from baseline to Day 360.

  Up to 360 days

Secondary Outcomes (13)

• Change in minimum fibrous cap thickness (FCT)

  Up to 360 days

• Change in mean minimum FCT of all images

  360 days

• Change in normalized total atheroma volume (NTAV)

  Up to 360 days

• Proportion of participants with progression, regression, or no change in PAV

  Up to 360 days

• Change in LDL-C

  Baseline, Day 30, Day 150 and Day 360

Study Arms (2)

Inclisiran and atorvastatin

EXPERIMENTAL

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

Drug: atorvastatin; Procedure: IVUS/OCT; Drug: inclisiran

atorvastatin

ACTIVE COMPARATOR

20mg atorvastatin PO

Drug: atorvastatin; Procedure: IVUS/OCT

Interventions

IVUS/OCT PROCEDURE

performed the IVUS/OCT at baseline and Day 360

Inclisiran and atorvastatin; atorvastatin

atorvastatin DRUG

20mg atorvastatin PO

Inclisiran and atorvastatin; atorvastatin

inclisiran DRUG

Inclisiran 284mg SC

Inclisiran and atorvastatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥ 18 and ≤ 75 years of age.
• Acute myocardial infarction (STEMI ≤ 24h/NSTEMI ≤ 72h of onset of symptoms) with planned PCI.
• At least 1 major, non-infarct-related coronary artery ("target vessel") meet all of the following criteria judged by the investigator:
• \) Presence of atherosclerotic plaque with ≥ 20% and ≤ 50% diameter stenosis by coronary angiography.
• \) Target vessel deemed to be accessible to imaging catheters and suitable for intravascular imaging in the proximal (50 mm) segment ("target segment") 3) Target vessel is suitable for IVUS and OCT evaluation. 4) Not have undergone previous PCI within target vessel. 5) Not be a bypass graft or a bypassed native vessel. 4. Rapid LDL-C test value at screening period of:
• LDL-C \> 1.8 mmol/L if on stable dose of statin (with or without ezetimibe) for ≥ 4 weeks upon signing ICF.
• LDL-C \> 2.6 mmol/L if not on stable dose of statin (with or without ezetimibe) for ≥ 4 weeks upon signing ICF.
• \. Written informed consent must be obtained.

You may not qualify if:

• Familial hypercholesterolemia or secondary hypercholesterolemia.
• Clinically instable AMI (hemodynamic or electrical instability).
• Left main disease, defined as ≥ 50% diameter stenosis of the left main coronary artery by coronary angiography.
• Three-vessel disease, defined as ≥ 70% diameter stenosis of 3 major epicardial coronary vessels or in major branches of these arteries by coronary angiography.
• Have a plan for interventional procedure within 12 months after signing ICF.
• Known intolerance to Atorvastatin OR known statin intolerance.
• Patients already on high-intensity statin including atorvastatin 40 or 80 mg or rosuvastatin 20 mg upon signing ICF.
• Patients not suitable for IVUS/OCT evaluation (e.g., significant calcification , etc) judged by the investigator.
• Patients qualify for coronary artery bypass surgery at screening and history of coronary artery bypass surgery.
• Cardiac disorders:
• \) Uncontrolled cardiac arrhythmia, defined as recurrent and symptomatic ventricular tachycardia or atrial fibrillation with rapid ventricular response not controlled by medications in the past 3 months prior to screening; 2) Pacemaker or ICD in situ; and/or 3) Uncontrolled severe hypertension with systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg prior to randomization despite antihypertensive therapy.
• \. Rapid lipid test triglyceride (TG) level \> 400mg/dL (4.5 mmol/L) at screening.
• \. Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver or unexplained elevations in alanine aminotransferase (ALT), aspartate aminotransferase (AST), \> 3x the upper limit of normal (ULN), or total bilirubin \> 2x ULN before the randomization.
• \. Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m2(Calculated according to the modified MDRD equation).
• \. Severe concomitant non-cardiovascular disease that carries the risk of reducing life expectancy to less than 2 years.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (20)

Novartis Investigative Site

Hefei, Anhui, 230001, China

RECRUITING

Novartis Investigative Site

Fuzhou, Fujian, 350001, China

RECRUITING

Novartis Investigative Site

Guangzhou, Guangdong, 510000, China

RECRUITING

Novartis Investigative Site

Guangzhou, Guangdong, 510030, China

RECRUITING

Novartis Investigative Site

Guangzhou, Guangdong, 510080, China

RECRUITING

Novartis Investigative Site

Shenzhen, Guangdong, 518000, China

RECRUITING

Novartis Investigative Site

Zunyi, Guizhou, 563000, China

RECRUITING

Novartis Investigative Site

Harbin, Heilongjiang, 150086, China

RECRUITING

Novartis Investigative Site

Zhengzhou, Henan, 450003, China

RECRUITING

Novartis Investigative Site

Wuhan, Hubei, 430060, China

RECRUITING

Novartis Investigative Site

Nanchang, Jiangxi, 330006, China

RECRUITING

Novartis Investigative Site

Changchun, Jilin, 130033, China

RECRUITING

Novartis Investigative Site

Dalian, Liaoning, 116023, China

RECRUITING

Novartis Investigative Site

Jining, Shandong, 272000, China

RECRUITING

Novartis Investigative Site

Xian, Shanxi, 710061, China

RECRUITING

Novartis Investigative Site

Chengdu, Sichuan, 610072, China

RECRUITING

Novartis Investigative Site

Wenzhou, Zhejiang, 325027, China

RECRUITING

Novartis Investigative Site

Beijing, 101149, China

RECRUITING

Novartis Investigative Site

Lanzhou, 730000, China

RECRUITING

Novartis Investigative Site

Tianjin, 300000, China

RECRUITING

MeSH Terms

Conditions

Plaque, Atherosclerotic

Interventions

Atorvastatin; ALN-PCS

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: IVUS/OCT will be conducted in local lab and blinded analyzed to Independent Review Committee(IRC).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 18, 2024
• Study Start: July 9, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): January 26, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (20)