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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 0 days
Awards & highlights
Pivotal Trial

Summary

This trial is testing inclisiran, an injectable drug, on people with heart disease who are already on strong cholesterol-lowering medications. The goal is to see if inclisiran can further reduce the risk of heart attacks and strokes by lowering bad cholesterol levels. Participants will receive the injection periodically. Inclisiran works by significantly reducing bad cholesterol levels.

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 days
Treatment ~ 36 months
Follow Up ~0 days
This trial's timeline: 3 days for screening, 36 months for treatment, and 0 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to First Occurrence of 3P-MACE (3-Point Major Adverse Cardiovascular Events)
Secondary study objectives
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.

Trial Design

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
PCSK9 inhibitors, such as Inclisiran, work by blocking the PCSK9 enzyme, which leads to increased recycling of LDL receptors and enhanced clearance of LDL cholesterol from the bloodstream. This results in significantly lower LDL cholesterol levels, reducing the risk of cardiovascular events. Statins, another common treatment, inhibit HMG-CoA reductase, an enzyme involved in cholesterol synthesis, thereby lowering LDL cholesterol levels. Ezetimibe works by inhibiting the absorption of cholesterol in the small intestine. These treatments are crucial for CVD patients as they help manage cholesterol levels, thereby reducing the risk of atherosclerosis, heart attacks, and strokes.

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
2,893 Previous Clinical Trials
4,184,451 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
~8486 spots leftby Oct 2027