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Plaque, AtheroscleroticPhase 4V-ACCELERATENCT06372925

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

A Phase 4 study testing atorvastatin, IVUS/OCT and inclisiran in people with Plaque, Atherosclerotic, run by Novartis Pharmaceuticals at 19 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Plaque, Atherosclerotic
What is being tested?
atorvastatin, IVUS/OCT and inclisiran
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
318 participants
Where
19 sitesChina
Study dates
9 Jul 2024to 26 Jan 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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:
  • 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.
  • 5. Written informed consent must be obtained.

Who cannot join

  • 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.
Show all 21Show fewer
  • 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:
  • 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.

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

China19 sites

  • Novartis Investigative Site

    Beijing, 101149

  • Novartis Investigative Site

    Changchun, Jilin, 130033

  • Novartis Investigative Site

    Chengdu, Sichuan, 610072

  • Novartis Investigative Site

    Dalian, Liaoning, 116023

  • Novartis Investigative Site

    Fuzhou, Fujian, 350001

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510000

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510080

  • Novartis Investigative Site

    Harbin, Heilongjiang, 150086

  • Novartis Investigative Site

    Hefei, Anhui, 230001

  • Novartis Investigative Site

    Jining, Shandong, 272000

  • Novartis Investigative Site

    Lanzhou, 730000

  • Novartis Investigative Site

    Nanchang, Jiangxi, 330006

  • Novartis Investigative Site

    Shenzhen, Guangdong, 518000

  • Novartis Investigative Site

    Tianjin, 300000

  • Novartis Investigative Site

    Wenzhou, Zhejiang, 325027

  • Novartis Investigative Site

    Wuhan, Hubei, 430060

  • Novartis Investigative Site

    Xian, Shanxi, 710061

  • Novartis Investigative Site

    Zhengzhou, Henan, 450003

  • Novartis Investigative Site

    Zunyi, Guizhou, 563000

Other trials in China

About this study

Official title: 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

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).

Read the detailed description

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

Being tested
atorvastatin, IVUS/OCT, inclisiran
Keywords
Acute myocardial infarction,, Atherosclerotic plaque,, Inclisiran,, IVUS,, OCT,, PCI
Medical subject headings
Plaque, Atherosclerotic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • atorvastatinDrug

    20mg atorvastatin PO

  • IVUS/OCTProcedure or surgery

    performed the IVUS/OCT at baseline and Day 360

  • inclisiranDrug

    Inclisiran 284mg SC

Study groups in NCT06372925
Study groupRoleWhat they receive
Inclisiran and atorvastatinExperimentalInclisiran 284mg SC (at D1,D90,D270)+ 20mg atorvastatin PO
Receives: Drug: atorvastatin; Procedure: IVUS/OCT; Drug: inclisiran
atorvastatinActive comparator20mg atorvastatin PO
Receives: Drug: atorvastatin; Procedure: IVUS/OCT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in percent atheroma volume (PAV)

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

    Measured: Up to 360 days

Secondary outcomes (13)

  1. Change in minimum fibrous cap thickness (FCT)

    Change in minimum FCT as determined by optical coherence tomography (OCT) from baseline to Day 360

    Measured: Up to 360 days

  2. Change in mean minimum FCT of all images

    Change in mean minimum fibrous cap thickness (FCT) of all images as determined by OCT from baseline to Day 360.

    Measured: 360 days

  3. Change in normalized total atheroma volume (NTAV)

    Change in NTAV as determined by intravascular ultrasound (IVUS) from baseline to Day 360

    Measured: Up to 360 days

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

    Proportion of participants with progression, regression, or no change in percent atheroma volume (PAV) at Day 360

    Measured: Up to 360 days

  5. Change in LDL-C

    Change in low-density lipoprotein cholesterol (LDL-C)

    Measured: Baseline, Day 30, Day 150 and Day 360

  6. Change in TC

    Change in total cholesterol (TC).

    Measured: Baseline, Day 30, Day 150 and Day 360

  7. Change in HDL-C

    Change in high-density lipoprotein cholesterol (HDL-C).

    Measured: Baseline, Day 30, Day 150 and Day 360

  8. Change in non-HDL-C

    Change in non-high-density lipoprotein cholesterol (non-HDL-C).

    Measured: Baseline, Day 30, Day 150 and Day 360

  9. Change in ApoB

    Change in apolipoprotein B (ApoB).

    Measured: Baseline, Day 30, Day 150 and Day 360

  10. Change in ApoA1

    Change in apolipoprotein A1 (ApoA1).

    Measured: Baseline, Day 30, Day 150 and Day 360

  11. Change in Lp(a)

    Change in lipoprotein (a) (Lp(a))

    Measured: Baseline, Day 30, Day 150 and Day 360

  12. Change in TG

    Change in triglycerides (TG)

    Measured: Baseline, Day 30, Day 150 and Day 360

  13. Proportion of participants with LDL-C target attainment

    Proportion of participants with LDL-C target attainment at Day 30, Day 150, and Day 360

    Measured: Day 30, Day 150 and Day 360

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2024
  2. Study start9 Jul 2024
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion26 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
318 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06372925
Sponsor's protocol ID
CKJX839A1CN04
Other IDs
CKJX839A1CN04
Acronym
V-ACCELERATE
Status last verified
Jul 2026
First submitted
15 Apr 2024
Last updated
28 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing atorvastatin, IVUS/OCT and inclisiran in people with Plaque, Atherosclerotic, run by Novartis Pharmaceuticals at 19 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in percent atheroma volume (PAV) (time frame: Up to 360 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06372925.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.

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