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siRNA

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)

Phase 3
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 90, day 180, day 270 and day 330
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

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.

Eligible Conditions
  • Atherosclerotic Cardiovascular Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 90, day 180, day 270 and day 330
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 90, day 180, day 270 and day 330 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent Change From Baseline in LDL-C
Percentage of Participants Who Discontinued Statin Therapy
Secondary study objectives
Absolute Change From Baseline in LDL-C
Absolute Change in Lipids and Other Lipoproteins From Baseline
Average Absolute Change From Baseline in LDL-C Levels Across Visits
+10 more

Side effects data

From 2019 Phase 3 trial • 482 Patients • NCT03397121
12%
Nasopharyngitis
9%
Injection site reaction
7%
Upper respiratory tract infection
7%
Back pain
5%
Influenza
1%
Acute myocardial infarction
1%
Aortic valve stenosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Inclisiran

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Inclisiran
2021
Completed Phase 3
~3220

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,916 Previous Clinical Trials
4,253,435 Total Patients Enrolled

Media Library

Inclisiran (siRNA) Clinical Trial Eligibility Overview. Trial Name: NCT04929249 — Phase 3
Cardiovascular Disease Research Study Groups: Inclisiran First, Usual Care
Cardiovascular Disease Clinical Trial 2023: Inclisiran Highlights & Side Effects. Trial Name: NCT04929249 — Phase 3
Inclisiran (siRNA) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04929249 — Phase 3
~102 spots leftby Dec 2025
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