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)
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
Novartis Pharmaceuticals
Principal Investigator
Novartis Pharmaceuticals
Eligibility Criteria
Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Inclisiran is administered initially at randomization, 90 days later, and six months thereafter
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Inclisiran
Inclisiran is already approved in European Union, United States, China for the following indications:
- Primary hypercholesterolemia (heterozygous familial and non-familial)
- Mixed dyslipidemia
- Heterozygous familial hypercholesterolemia (HeFH)
- Clinical atherosclerotic cardiovascular disease (ASCVD)
- Primary hypercholesterolemia
- Primary hypercholesterolemia (heterozygous familial and non-familial)
- Mixed dyslipidemia
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Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD