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siRNA

Inclisiran for Cardiovascular Disease (VICTORION-2P Trial)

Verified Trial
Phase 3
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have you experienced a heart attack, stroke, or peripheral arterial disease?
Are you current on lipid-lowering regimen that includes medications like statins?
Timeline
Screening 3 days
Treatment 36 months
Follow Up from randomization to total follow-up time (up to 72 months)
Awards & highlights

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.

Who is the study for?
This trial is for people with a history of heart issues like heart attacks, strokes, or peripheral arterial disease. They should be on a stable cholesterol-lowering regimen but not taking PCSK9 inhibitors. Those with severe non-heart diseases, pregnant women, and individuals who've had recent cardiovascular events or used inclisiran before are excluded.Check my eligibility
What is being tested?
The study tests if Inclisiran can prevent major heart problems in those already diagnosed with heart disease compared to a placebo. Participants will randomly receive either Inclisiran sodium 300 mg or a placebo to see which is more effective at reducing cardiovascular events.See study design
What are the potential side effects?
While the specific side effects of Inclisiran aren't listed here, similar medications often cause injection site reactions, flu-like symptoms, nausea, muscle pain, and potentially liver-related issues.

VICTORION-2P Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had a heart attack, stroke, or peripheral arterial disease.
Select...
I am currently taking medication to lower my cholesterol.
Select...
I am not using nor planning to use PCSK9 inhibitors like Repatha or Praluent.

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

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

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,859 Previous Clinical Trials
4,181,744 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 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
Other
California
Tennessee
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?
2
0
What site did they apply to?
Novartis Investigative Site
Accellacare Research Site (37938)
Other

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

Why did patients apply to this trial?

To help me be healthier. If you can make a difference I will try it. to clear my body of plague and try to stay healthy.
PatientReceived 1 prior treatment
I am looking for solutions for my medical condition. I have not been diagnosed. I think I responded in error.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Email
Phone Call
Most responsive sites:
  1. Accellacare Research Site (37938): < 48 hours
  2. Novartis Investigative Site: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease
2021. "Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05030428.
All > Atherosclerosis
~9664 spots leftby Oct 2027
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