← Back to Search

siRNA

Inclisiran for Cardiovascular Disease (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 to day 330
Awards & highlights

V-INITIATE Trial Summary

This trial is testing if adding inclisiran to statin therapy right away, instead of the usual care, is more effective in treating ASCVD.

Eligible Conditions
  • Atherosclerotic Cardiovascular Disease

V-INITIATE Trial Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Discontinuation of statin therapy (i.e., no statin use ≥ 30 days before the end-of-study visit) (yes, no)
Percent change from baseline in LDL-C
Secondary outcome measures
Absolute change from baseline in LDL-C
Achieving LDL-C < 100 mg/dL (among the subset of participants with LDL-C >100 mg/dL at baseline) (yes, no)
Achieving LDL-C < 55 mg/dL (yes, no)
+14 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

V-INITIATE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Inclisiran FirstExperimental Treatment1 Intervention
Inclisiran + usual care
Group II: Usual CareActive Control1 Intervention
Usual care
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Inclisiran
2021
Completed Phase 3
~2240

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,863 Previous Clinical Trials
4,198,885 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we enrolling patients at this time for this research?

"That is correct, the online information does show that this clinical trial is still looking for participants. The first posting was on June 25th 2021 and there have been subsequent updates to the page, with the latest one being on October 17th 2022. In total, they are trying to get 444 people involved at 40 different hospitals or clinics."

Answered by AI

What other research has been conducted on Inclisiran?

"Out of the 11 ongoing studies investigating Inclisiran, 10 are currently in Phase 3. Most of these live clinical trials are being conducted in Ciudad de Mexico, but Inclisiran is also being studied at 1414 other locations around the world."

Answered by AI

When might Inclisiran be cleared for public use by the FDA?

"Inclisiran is considered safe according to our team's 3-point scale. This is due to the fact that Phase 3 trials have provided some data affirming the drug's efficacy as well as multiple rounds of data supporting its safety."

Answered by AI

Is this the initial research project of its sort?

"There have been 11 clinical trials for Inclisiran since 2018, with the most recent one concluding earlier this year. These studies took place in 588 cities and 52 countries across the globe. The first study, sponsored by Novartis Pharmaceuticals, completed its Phase 3 drug approval stage in 2018."

Answered by AI

What is Inclisiran's most common therapeutic target?

"While primary hypercholesterolemia is the most common reason to use Inclisiran, this medication can also help patients with diet-controlled hypercholesterolemia and atherosclerotic cardiovascular diseases."

Answered by AI

How many subjects are enrolled in this trial?

"That is right, the clinicaltrials.gov website has information which says that this research project is looking for more participants. The first posting was on 6/25/2021 and there have been updates as recently as 10/17/2022. So far, 444 people have signed up across 40 different locations."

Answered by AI

Are there different research facilities that are testing this in the United States?

"Presently, this clinical trial is being conducted at 40 different sites. The locations are situated in Marshfield, Weston and Hershey as well as other cities. If you elect to participate in this research study, it would be advantageous to select the clinic nearest your location to reduce travel requirements."

Answered by AI

What are the goals that researchers are hoping to achieve with this clinical trial?

"The primary objective of this trial, which will be measured over a period of 330 days, is the change in LDL cholesterol levels from baseline. Additionally, this trial will also measure secondary outcomes including changes in VLDL cholesterol and apoB levels, as well as the intensity of lipid-lowering therapy (i.e. whether the dose is increased, decreased, or remains unchanged) over the same time period."

Answered by AI
~117 spots leftby May 2025