What side effects are associated with this type of intervention?

PCSK9 inhibitors, such as alirocumab and evolocumab, are generally well-tolerated but can cause some side effects. Commonly reported adverse effects include mild injection site reactions (e.g., erythema, pain, or bruising), which occur in 6 to 10 percent of patients. Hypersensitivity reactions like rash, pruritus, and urticaria have also been noted, with serious allergic reactions being rare. Neurocognitive symptoms have been reported in less than 1 percent of cases, but no significant evidence of neurocognitive impairment was found in larger studies. Muscle toxicity and elevated liver enzymes are not typically associated with PCSK9 inhibitors.

What prior FDA approvals exist?

The FDA has approved several treatments for cardiovascular disease, including PCSK9 inhibitors like alirocumab (Praluent) and evolocumab (Repatha), which are monoclonal antibodies that lower LDL cholesterol. These drugs are similar to Inclisiran, which uses siRNA technology to inhibit PCSK9. Other notable FDA-approved treatments include statins, which are widely used to lower cholesterol, and antiplatelet agents like aspirin and clopidogrel, which help prevent blood clots. Additionally, newer therapies such as sodium-glucose co-transporter 2 (SGLT2) inhibitors and mineralocorticoid receptor antagonists are used in managing heart failure.

What other types of research exist?

Promising alternatives to Inclisiran for cardiovascular disease patients include: 1) Evolocumab and Alirocumab, which are monoclonal antibodies that inhibit PCSK9 and have shown efficacy in lowering LDL-C levels. 2) Antisense oligonucleotide therapies like Apo(a)-LRx, which target lipoprotein(a) and have demonstrated significant reductions in Lp(a) levels. 3) Gene therapies targeting lipid metabolism, such as those using adenoviral vectors to correct LDL receptor deficiencies, are also in development and show potential for long-term management of hypercholesterolemia.

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siRNA

Inclisiran for Cardiovascular Disease (VICTORION-2P Trial)

Verified Trial

Phase 3

Waitlist Available

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 days1 visit

Treatment ~ 36 months6 visits

Follow Up ~ 0 days0 visits

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

0 / 3Eligibility criteria met

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.