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RNA-based Therapeutic

Inclisiran for Cardiovascular Disease Prevention

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
Participants at an increased risk for a first MACE (i.e., no prior major ASCVD event)
Intermediate 10-year ASCVD risk 7.5% - <20% with at least 2 risk-enhancing factors
Must not have
History of major ASCVD event
Timeline
Screening 1 day
Treatment Varies
Follow Up time to the first occurrence of 4p-mace (up to approximately 75 months)
Awards & highlights

Study Summary

This trial tests if inclisiran sodium can reduce the risk of major cardiovascular events in people at high risk of heart disease.

Who is the study for?
This trial is for adults aged 40-80 with high cholesterol and at increased risk of a first major cardiovascular event, but who haven't had one before. They should have an intermediate 10-year heart disease risk score with additional risk factors. Pregnant women, nursing mothers, or those in another study can't participate.Check my eligibility
What is being tested?
The trial tests if Inclisiran sodium (a drug given by injection) can prevent serious heart-related events when administered initially, after three months, and then every six months compared to a placebo. The goal is to see if it reduces the occurrence of events like heart attacks or strokes.See study design
What are the potential side effects?
While specific side effects are not listed here, Inclisiran may cause reactions at the injection site, allergic responses, liver enzyme changes, muscle pain or weakness among others based on its mechanism of action.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have a higher risk of experiencing a first major cardiovascular event and have not had one before.
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My heart disease risk for the next 10 years is between 7.5% and 20%, and I have at least two risk factors.
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I am between 40 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a major heart or blood vessel event.

Timeline

Screening ~ 1 day
Treatment ~ Varies
Follow Up ~time to the first occurrence of 4p-mace (up to approximately 75 months)
This trial's timeline: 1 day for screening, Varies for treatment, and time to the first occurrence of 4p-mace (up to approximately 75 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 the first occurrence of 4P-MACE
Secondary outcome measures
Time to occurrence of Cardiovascular death
Time to occurrence of death due to any reason
Time to the first occurrence of 3P-MACE
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Inclisiran Sodium 300mgExperimental Treatment1 Intervention
Inclisiran sodium 300 mg in 1.5 mL Solution for injection (subcutaneous) in pre-filled syringe. Randomized in a 1:1 ratio with matching placebo
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo in 1.5ml pre-filled syringe. Randomized in a 1:1 ratio with Inclisiran.

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
2,860 Previous Clinical Trials
4,184,309 Total Patients Enrolled

Media Library

Inclisiran sodium (RNA-based Therapeutic) Clinical Trial Eligibility Overview. Trial Name: NCT05739383 — Phase 3
Type 2 Diabetes Research Study Groups: Inclisiran Sodium 300mg, Placebo
Type 2 Diabetes Clinical Trial 2023: Inclisiran sodium Highlights & Side Effects. Trial Name: NCT05739383 — Phase 3
Inclisiran sodium (RNA-based Therapeutic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05739383 — Phase 3
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT05739383 — Phase 3

Frequently Asked Questions

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

Has the FDA sanctioned Inclisiran Sodium 300mg for usage?

"The safety of Inclisiran Sodium 300mg was deemed satisfactory, garnering a score of 3. This is due to the existing body of evidence proving its efficacy and multiple studies affirming its security parameters."

Answered by AI

Is this medical trial open to minors?

"According to the inclusion criteria, only individuals aged between 40 and 79 may enrol in this trial. There are 31 studies conducted on persons under 18 years old, as well as 463 for those who exceed 65."

Answered by AI

Is recruitment for this trial still open to new participants?

"According to the information advertised on clinicaltrials.gov, this trial is actively recruiting participants. The original post was made on March 9th 2023 while its most recent update occurred on 23rd of the same month."

Answered by AI

How many participants has this trial recruited thus far?

"Indeed, the clinicaltrials.gov database shows that this trial is still enrolling participants. The research first appeared on March 9th 2023 and was last updated two weeks later on March 23rd 2023. In total, 14000 patients are being sought from 8 different sites."

Answered by AI

What is the geographical scope of this clinical trial?

"8 medical centres in the United States are currently enrolling patients, including Covington, Zachary and Amarillo. To minimise travel expenses related to participation in this study it is advised that you select the closest site to your location."

Answered by AI

To which demographic is enrollment in this trial available?

"This clinical trial seeks to enrol 14,000 patients aged 40-79 with the purpose of preventing atherosclerotic cardiovascular disease. The contenders must meet a few criteria such as having a stable dose of lipid-lowering medication for 4 weeks before screening and an LDL cholesterol concentration between 70 mg/dL (1.81 mmol/L) and 190 mg/dL (4.91 mmol/L). Furthermore, they should have either coronary artery calcium score ≥100 Agatston units or evidence of CAD on CT scan representing stenosis 20%-50% in left main coronary artery & 20%-70% any major epicardial vessel"

Answered by AI

Who else is applying?

What state do they live in?
Florida
Tennessee
New Jersey
What site did they apply to?
Novartis Investigative Site
Tustin Research Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0

What questions have other patients asked about this trial?

How long will the study last? How long does a screening visit normally take?
PatientReceived 2+ prior treatments
How long is the trial? Is there compensation or money for travel.?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

I have tried 3 times. I want to be healthy in every way. It looks interesting and I need money.
PatientReceived no prior treatments
I want to decrease my risk of heart disease. I need something to lower my elevated Lp(a).
PatientReceived no prior treatments

How responsive is this trial?

Most responsive sites:
  1. Novartis Investigative Site: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Email
~9333 spots leftby Apr 2029