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 in Palo Alto (17 mi)

+80 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Novartis Pharmaceuticals

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

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.

Eligibility Criteria

Inclusion Criteria

Signed informed consent must be obtained prior to participation in the study

Males and females ≥18 years of age

History of ASCVD, documented by hospital records, claims data and/or prior laboratory/imaging assessments

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

Treatment Details

Interventions

• Inclisiran (siRNA)

Participant Groups

Group I: Inclisiran First Experimental Treatment 1 Intervention

Inclisiran sodium 300 mg 1.5 ml (equivalent to 284 mg of inclisiran) + usual care

Group II: Usual Care Active Control 1 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

Research Locations Nearby Select from list below to view details:

Capital Area Research Newport, PA

Cardiology Consultants of Philadelphia Yardley, PA

Alliance for Multispecialty Res LLC Nashville, TN

Cypress Heart and Vascular Center Cypress, TX

More Trial Locations

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals Lead Sponsor

References