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

Last updated: January 20, 2026
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Not Recruiting

Phase

4

Condition

Angina

Heart Defect

Coronary Artery Disease

Treatment

atorvastatin

IVUS/OCT

inclisiran

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 by coronary angiography.

  2. 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:

  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 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
  2. Uncontrolled severe hypertension with systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg prior to randomization despite antihypertensive therapy.
  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, 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.

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

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

  5. Previous (within 90 days before randomization), current or planned treatment with a PCSK9 monoclonal antibody (mAb).

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

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

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

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

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

Study Design

Total Participants: 318
Treatment Group(s): 3
Primary Treatment: atorvastatin
Phase: 4
Study Start date:
July 09, 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

    Hefei, An Hui 230001
    China

    Site Not Available

  • Novartis Investigative Site

    Hefei 1808722, Anhui 1818058 230001
    China

    Site Not Available

  • Novartis Investigative Site

    Fuzhou, Fujian 350001
    China

    Site Not Available

  • Novartis Investigative Site

    Fuzhou 1810821, Fujian 1811017 350001
    China

    Site Not Available

  • Novartis Investigative Site

    Guangzhou, Guangdong 510000
    China

    Site Not Available

  • Novartis Investigative Site

    Shenzhen, Guangdong 518000
    China

    Site Not Available

  • Novartis Investigative Site

    Guangzhou 1809858, Guangdong 1809935 510000
    China

    Site Not Available

  • Novartis Investigative Site

    Shenzhen 1795565, Guangdong 1809935 518000
    China

    Site Not Available

  • Novartis Investigative Site

    Zunyi, Guizhou 563000
    China

    Site Not Available

  • Novartis Investigative Site

    Zunyi 1783621, Guizhou 1809445 563000
    China

    Site Not Available

  • Novartis Investigative Site

    Harbin, Heilongjiang 150086
    China

    Site Not Available

  • Novartis Investigative Site

    Harbin 2037013, Heilongjiang 2036965 150086
    China

    Site Not Available

  • Novartis Investigative Site

    Zhengzhou, Henan 450052
    China

    Site Not Available

  • Novartis Investigative Site

    Zhengzhou 1784658, Henan 1808520 450003
    China

    Site Not Available

  • Novartis Investigative Site

    Wuhan, Hubei 430060
    China

    Site Not Available

  • Novartis Investigative Site

    Wuhan 1791247, Hubei 1806949 430060
    China

    Site Not Available

  • Novartis Investigative Site

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • Novartis Investigative Site

    Nanchang 1800163, Jiangxi 1806222 330006
    China

    Site Not Available

  • Novartis Investigative Site

    Changchun, Jilin 130033
    China

    Site Not Available

  • Novartis Investigative Site

    Changchun 2038180, Jilin 2036500 130033
    China

    Site Not Available

  • Novartis Investigative Site

    Dalian, Liaoning 116000
    China

    Site Not Available

  • Novartis Investigative Site

    Dalian 1814087, Liaoning 2036115 116023
    China

    Site Not Available

  • Novartis Investigative Site

    Jining, Shandong 272000
    China

    Site Not Available

  • Novartis Investigative Site

    Jining 1805518, Shandong 1796328 272000
    China

    Site Not Available

  • Novartis Investigative Site

    Xian, Shanxi 1795912 710061
    China

    Site Not Available

  • Novartis Investigative Site

    Chengdu, Sichuan 610072
    China

    Site Not Available

  • Novartis Investigative Site

    Chengdu 1815286, Sichuan 1794299 610072
    China

    Site Not Available

  • Novartis Investigative Site

    Wenzhou, Zhejiang 325027
    China

    Site Not Available

  • Novartis Investigative Site

    Wenzhou 1791388, Zhejiang 1784764 325027
    China

    Site Not Available

  • Novartis Investigative Site

    Beijing, 101149
    China

    Site Not Available

  • Novartis Investigative Site

    Beijing 1816670, 101149
    China

    Site Not Available

  • Novartis Investigative Site

    Lanzhou, 730000
    China

    Site Not Available

  • Novartis Investigative Site

    Lanzhou 1804430, 730000
    China

    Site Not Available

  • Novartis Investigative Site

    Tianjin, 300000
    China

    Site Not Available

  • Novartis Investigative Site

    Tianjin 1792947, 300000
    China

    Site Not Available

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