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Inclisiran for Cardiovascular Disease(VICTORION-2P Trial)

Verified Trial
Phase 3
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Answer yes if you are not currently taking or planning to take PCSK9 inhibitors. These are medications like Repatha (Evolocumab) and Praluent (Alirocumab).
Are you current on lipid-lowering regimen that includes medications like statins?
Must not have
Be younger than 18 years old
Screening 3 days
Treatment 36 months
Follow Upfrom randomization to total follow-up time (up to 72 months)
Awards & highlights
Pivotal Trial

VICTORION-2P Trial Summary

This trial is testing a new drug to see if it can help prevent major heart problems in people who already have heart disease.

Eligible Conditions
  • Atherosclerotic Cardiovascular Disease

VICTORION-2P Trial Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

VICTORION-2P Trial Timeline

Screening ~ 3 days
Treatment ~ 36 months
Follow Up ~from randomization to total follow-up time (up to 72 months)
This trial's timeline: 3 days for screening, 36 months for treatment, and from randomization to total follow-up time (up to 72 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to First Occurrence of 3P-MACE (3-Point Major Adverse Cardiovascular Events)
Secondary outcome measures
Time to First Occurrence of 4P-MACE (4-Point Major Adverse Cardiovascular Events)
Time to Occurrence of Cardiovascular (CV) Death
Time to first occurrence of Major Limb Adverse Events (MALE)
+1 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

VICTORION-2P Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Inclisiran sodiumExperimental Treatment1 Intervention
Subcutaneous injection
Group II: PlaceboPlacebo Group1 Intervention
Subcutaneous injection

Find a Location


Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,819 Previous Clinical Trials
4,018,055 Total Patients Enrolled

Media Library

Inclisiran (siRNA) Clinical Trial Eligibility Overview. Trial Name: NCT05030428 — Phase 3
Cardiovascular Disease Research Study Groups: Inclisiran sodium, Placebo
Cardiovascular Disease Clinical Trial 2023: Inclisiran Highlights & Side Effects. Trial Name: NCT05030428 — Phase 3
Inclisiran (siRNA) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05030428 — Phase 3
Cardiovascular Disease Patient Testimony for trial: Trial Name: NCT05030428 — Phase 3

Frequently Asked Questions

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

Can you tell me how many different hospitals are participating in this research project?

"There are 100 sites running this trial, such as Meridian Clinical Research in Crowley, Samaritan Cardiology in Munster, and Inpatient Research Clinical LLC in Eunice."

Answered by AI

Has Inclisiran sodium 300 mg been cleared by the FDA?

"Inclisiran sodium 300 mg is in Phase 3 of clinical trials. This means that there is some data to support its efficacy and multiple rounds of data supporting safety, so our team at Power gave it a score of 3 for safety."

Answered by AI

What are some common reasons why doctors prescribe Inclisiran sodium 300 mg?

"Inclisiran sodium 300mg can be used as a treatment for primary hypercholesterolemia, hypercholesterolemia, and diet."

Answered by AI

Have there been any other similar studies to this one in the past?

"Inclisiran sodium 300 mg has been under scientific observation since 2018. After the first clinical trial, which was sponsored by Novartis Pharmaceuticals and conducted in 2018 with 15000 participants, Inclisiran sodium 300 mg received Phase 3 drug approval. There are currently 11 active studies involving Inclisiran sodium 300 mg spanning 588 cities and 52 countries."

Answered by AI

What is the patient quota for this experiment?

"In order for this trial to move forward, 15000 volunteers that fit the pre-determined inclusion criteria must participate. Those interested can sign up at Meridian Clinical Research in Crowley, Louisiana and Samaritan Cardiology, Louisiana and Samaritan Cardiology in Munster, Indiana."

Answered by AI

Is this research project still looking for volunteers?

"Yes, this trial is still recruiting patients according to the information available on clinicaltrials.gov. This particular study was posted on 11/23/2021 and edited as recently as 9/28/2022."

Answered by AI

Are there other research studies that have used Inclisiran sodium 300 mg?

"There are 11 different ongoing clinical trials looking into the effects of Inclisiran sodium 300 mg. The majority of these studies are in Phase 3 and originate from Mexico City. However, there are a total of 1414 trial locations for Inclisiran sodium 300 mg around the world."

Answered by AI

Who else is applying?

What state do they live in?
British Columbia
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
What site did they apply to?
Novartis Investigative Site
Meridian Clinical Research LLC
Accellacare Research Site (37938)

Why did patients apply to this trial?

If you can make a difference I will try it. to clear my body of plague and try to stay healthy.
PatientReceived no prior treatments
I have not been diagnosed. I think I responded in error. I've been in several clinical trials and feel I am helping the world.
PatientReceived 1 prior treatment
I think I have heart problems and I would like to see what the trial is about.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How many months for this trial? Do you have studies near my hometown? How long do the visits last? Is the first visit longer? If I have to travel out of state do you provide airline travel?
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Accellacare Research Site (37938): < 48 hours
  2. Novartis Investigative Site: < 48 hours
Average response time
  • < 2 Days
~10843 spots leftby Oct 2027