450 Participants Needed

A Randomized Study to Evaluate the Effect of an "Inclisiran First" Implementation Strategy Compared to Usual Care in Patients With Atherosclerotic Cardiovascular Disease and Elevated LDL-C Despite Receiving Maximally Tolerated Statin Therapy (VICTORION-INITIATE)

(V-INITIATE Trial)

Recruiting at 80 trial locations
NP
Overseen ByNovartis Pharmaceuticals
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Novartis Pharmaceuticals
Must be taking: Statins
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires participants to be on the highest dose of statins they can tolerate. If you are statin intolerant, you can still participate if you've had side effects from at least two different statins.

How is the drug Inclisiran different from other treatments for its condition?

Inclisiran is unique because it is a small interfering RNA (siRNA) therapy that targets PCSK9, a protein involved in cholesterol regulation, and is administered via injection only twice a year, offering a novel approach compared to traditional cholesterol-lowering medications that require more frequent dosing.12345

What is the purpose of this trial?

This trial is testing whether adding inclisiran to statin therapy helps adults with heart disease and high cholesterol better than usual care. Inclisiran helps lower bad cholesterol by aiding the liver in removing it from the blood.

Research Team

NP

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

Inclusion Criteria

Signed informed consent must be obtained prior to participation in the study
History of ASCVD, documented by hospital records, claims data and/or prior laboratory/imaging assessments
Serum LDL-C ≥70 mg/dL or non-HDL-C ≥100 mg/dL
See 4 more

Exclusion Criteria

An underlying known disease, or surgical, physical, or medical condition that, in the opinion of the investigator (or delegate) might interfere with interpretation of the clinical study results
You have had a bad reaction or allergy to any of the study treatments or their ingredients, or to similar drugs in the past.
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 [or delegate] judgment) if he/she participates in the clinical study
See 11 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Inclisiran is administered initially at randomization, 90 days later, and six months thereafter

330 days
Visits at randomization, Day 90, Day 180, and Day 330

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Inclisiran
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Inclisiran FirstExperimental Treatment1 Intervention
Inclisiran sodium 300 mg 1.5 ml (equivalent to 284 mg of inclisiran) + usual care
Group II: Usual CareActive Control1 Intervention
Treating physicians were recommended to treat patients in accordance with the 2018 ACC/AHA guidelines

Inclisiran is already approved in European Union, United States, China for the following indications:

🇪🇺
Approved in European Union as Leqvio for:
  • Primary hypercholesterolemia (heterozygous familial and non-familial)
  • Mixed dyslipidemia
🇺🇸
Approved in United States as Leqvio for:
  • Heterozygous familial hypercholesterolemia (HeFH)
  • Clinical atherosclerotic cardiovascular disease (ASCVD)
  • Primary hypercholesterolemia
🇨🇳
Approved in China as Leqvio for:
  • Primary hypercholesterolemia (heterozygous familial and non-familial)
  • Mixed dyslipidemia

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials
2,963
Recruited
4,275,000+
Founded
1996
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Gleevec, Cosentyx, Entresto, Kisqali
Dr. Vas Narasimhan profile image

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye profile image

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

References

Human beta interferon scaffold attachment region inhibits de novo methylation and confers long-term, copy number-dependent expression to a retroviral vector. [2019]
COP9 signalosome subunit 6 binds and inhibits avian leukosis virus integrase. [2017]
An avian leukosis virus subgroup J isolate with a Rous sarcoma virus-like 5'-LTR shows enhanced replication capability. [2020]
A defective retroviral vector encoding human interferon-alpha2 can transduce human leukemic cell lines. [2013]
Genetics of the replication and maintenance functions of the hemolytic plasmid pSU316. Cloning of an IncFIII determinant. [2019]
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