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

Last updated: March 14, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

4

Condition

Angina

Heart Defect

Coronary Artery Disease

Treatment

inclisiran

IVUS/OCT

atorvastatin

Clinical Study ID

NCT06372925
CKJX839A1CN04
CKJX839A1CN04
  • Ages 18-75
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female ≥ 18 and ≤ 75 years of age.

  2. Acute myocardial infarction (STEMI ≤ 24h/NSTEMI ≤ 72h of onset of symptoms) withplanned PCI.

  3. At least 1 major, non-infarct-related coronary artery ("target vessel") meet all ofthe following criteria judged by the investigator:

  1. Presence of atherosclerotic plaque with ≥ 20% and ≤ 50% diameter stenosis bycoronary angiography.

  2. Target vessel deemed to be accessible to imaging catheters and suitable forintravascular imaging in the proximal (50 mm) segment ("target segment") 3) Targetvessel is suitable for IVUS and OCT evaluation. 4) Not have undergone previous PCIwithin target vessel. 5) Not be a bypass graft or a bypassed native vessel. 4. RapidLDL-C test value at screening period of:

  1. LDL-C > 1.8 mmol/L if on stable dose of statin (with or without ezetimibe) for ≥ 4weeks upon signing ICF.

  2. LDL-C > 2.6 mmol/L if not on stable dose of statin (with or without ezetimibe) for ≥ 4 weeks upon signing ICF.

  3. Written informed consent must be obtained.

Exclusion

Exclusion Criteria:

  1. Familial hypercholesterolemia or secondary hypercholesterolemia.

  2. Clinically instable AMI (hemodynamic or electrical instability).

  3. Left main disease, defined as ≥ 50% diameter stenosis of the left main coronaryartery by coronary angiography.

  4. Three-vessel disease, defined as ≥ 70% diameter stenosis of 3 major epicardialcoronary vessels or in major branches of these arteries by coronary angiography.

  5. Have a plan for interventional procedure within 12 months after signing ICF.

  6. Known intolerance to Atorvastatin OR known statin intolerance.

  7. Patients already on high-intensity statin including atorvastatin 40 or 80 mg orrosuvastatin 20 mg upon signing ICF.

  8. Patients not suitable for IVUS/OCT evaluation (e.g., significant calcification ,etc) judged by the investigator.

  9. Patients qualify for coronary artery bypass surgery at screening and history ofcoronary artery bypass surgery.

  10. Cardiac disorders:

  1. Uncontrolled cardiac arrhythmia, defined as recurrent and symptomatic ventriculartachycardia or atrial fibrillation with rapid ventricular response not controlled bymedications 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 ordiastolic blood pressure >110 mmHg prior to randomization despite antihypertensivetherapy.
  1. Rapid lipid test triglyceride (TG) level > 400mg/dL (4.5 mmol/L) at screening.

  2. Active liver disease defined as any known current infectious, neoplastic, ormetabolic pathology of the liver or unexplained elevations in alanineaminotransferase (ALT), aspartate aminotransferase (AST), > 3x the upper limit ofnormal (ULN), or total bilirubin > 2x ULN before the randomization.

  3. Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2(Calculated accordingto the modified MDRD equation).

  4. Severe concomitant non-cardiovascular disease that carries the risk of reducing lifeexpectancy to less than 2 years.

  5. Previous (within 90 days before randomization), current or planned treatment with aPCSK9 monoclonal antibody (mAb).

  6. Previous exposure to Inclisiran or any other non-mAb PCSK9-targeted therapy 2 yearsprior to randomization.

  7. Participation in another investigational device or drug study currently, or within 5half-live (if drug) or 30 days whichever is longer, prior to randomization.

  8. History of hypersensitivity to any study drug or its excipients. 19. Anyuncontrolled or serious disease, or any medical or surgical condition, that mayeither interfere with participation in the clinical study and/or put the participantat significant risk according to investigator's judgment.

  9. Pregnant or nursing (lactating) women. 21. Women of child-bearing potential, unlessthey are using effective methods of contraception during study treatment.

  10. Any conditions that according to the investigator could interfere with the conductof the study.

Study Design

Total Participants: 318
Treatment Group(s): 3
Primary Treatment: inclisiran
Phase: 4
Study Start date:
July 12, 2024
Estimated Completion Date:
June 24, 2026

Study Description

This study will be a multi-center, randomized, parallel-group, open-label, phase 4 study. Participants will be approximately 318 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.

Connect with a study center

  • Novartis Investigative Site

    Harbin, Heilongjiang 150086
    China

    Active - Recruiting

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