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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 belowSelect...
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.
Timeline
Screening ~ 3 days1 visit
Treatment ~ 36 months6 visits
Follow Up ~ 0 days0 visits
Screening ~ 3 days
Treatment ~ 36 months
Follow Up ~0 days
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 moreAwards & 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had a stroke more than 4 weeks ago.I haven't taken inclisiran or similar PCSK9 drugs in the last 2 years.You are currently pregnant or breastfeeding.I have had a heart attack, stroke, or peripheral arterial disease.I have been on a stable high-dose statin treatment for my cholesterol for at least 4 weeks.I have not used PCSK9 inhibitors recently and don't plan to start them soon.I am not using nor planning to use PCSK9 inhibitors like Repatha or Praluent.I have leg pain from poor circulation or have had surgery or an amputation due to this.I have a serious illness besides heart disease that may shorten my life to under 5 years.My heart condition severely limits my daily activities.I have a diagnosed heart condition.I had a heart attack more than 4 weeks ago.There may be additional requirements that you have to meet or factors that exclude you from participating in the study based on the specific details of the study.I haven't had a heart attack, stroke, or surgery for artery disease in the last 4 weeks.I am currently taking medication to lower my cholesterol.
Research Study Groups:
This trial has the following groups:- Group 1: Inclisiran sodium
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 36 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 0 Months after you stop receiving the treatment.
Cardiovascular Disease Patient Testimony for trial: Trial Name: NCT05030428 — Phase 3
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