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Evaluating Inclisiran's effect on coronary plaque in heart attack patients

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

Phase 4 Interventional Novartis · NCT06372925

This study is testing if adding Inclisiran to a common cholesterol medication can help reduce heart artery plaque in patients who have recently had a heart attack.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment334 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorNovartis Industry-sponsored
Locations20 sites (Hefei, Anhui and 19 other locations)
Trial IDNCT06372925 on ClinicalTrials.gov

What this trial studies

This study evaluates the impact of Inclisiran on coronary atherosclerosis in patients who have experienced an acute myocardial infarction and have elevated levels of low-density lipoprotein cholesterol (LDL-C). It is a multi-center, randomized, open-label phase 4 study involving approximately 318 Chinese adults. Participants will be randomly assigned to receive either Inclisiran combined with atorvastatin or atorvastatin alone for a duration of 360 days. The study will utilize intravascular ultrasound (IVUS) and optical coherence tomography (OCT) to assess changes in atherosclerotic plaque.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 who have recently experienced an acute myocardial infarction and have elevated LDL-C levels.

Not a fit: Patients who have undergone previous PCI in the target vessel or those with bypass grafts may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients with coronary artery disease by effectively reducing atherosclerotic plaque.

How similar studies have performed: Other studies have shown promising results with similar approaches to managing atherosclerosis, suggesting potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Male or female ≥ 18 and ≤ 75 years of age.
2. Acute myocardial infarction (STEMI ≤ 24h/NSTEMI ≤ 72h of onset of symptoms) with planned PCI.
3. At least 1 major, non-infarct-related coronary artery ("target vessel") meet all of the 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 ≥ 4 weeks 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.

5\. Written informed consent must be obtained.

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 coronary artery by coronary angiography.
4. Three-vessel disease, defined as ≥ 70% diameter stenosis of 3 major epicardial coronary 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 or rosuvastatin 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 of coronary 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 3) Uncontrolled severe hypertension with systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg prior to randomization despite antihypertensive therapy.

11\. Rapid lipid test triglyceride (TG) level \> 400mg/dL (4.5 mmol/L) at screening.

12\. 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.

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

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

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

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

17\. 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.

18\. 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.

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

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

Where this trial is running

Hefei, Anhui and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Plaque, AtheroscleroticAcute myocardial infarction,Atherosclerotic plaque,Inclisiran,IVUS,OCT,PCI
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.