Inclisiran for Cardiovascular Disease
(VICTORION-2P Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the effectiveness of inclisiran in reducing major heart-related problems in individuals with cardiovascular disease (CVD). Inclisiran, administered as an injection, will be compared to a placebo, a harmless substance without active medicine. The trial targets individuals who have experienced heart attacks, strokes, or specific leg artery issues and are on a stable cholesterol-lowering medication regimen. Participants should have an LDL cholesterol level of 70 mg/dL or higher and be on high-intensity statin therapy. The primary goal is to determine if inclisiran can lower the risk of serious heart issues. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to potentially groundbreaking treatment advancements.
Do I have to stop taking my current medications for the trial?
The trial requires participants to be on a stable lipid-lowering regimen that includes high-intensity statin therapy. If you are taking PCSK9 inhibitors, you must stop them at least 90 days before the trial. Other medications are not specifically mentioned, so it's best to discuss with the trial team.
Is there any evidence suggesting that inclisiran is likely to be safe for humans?
Research has shown that inclisiran is generally safe for people with heart conditions. Long-term studies indicate that most patients tolerate inclisiran well, with no new safety issues emerging over time. This means no unexpected side effects have made it unsafe.
One study found that inclisiran reduced bad cholesterol (LDL-C) by over 50% after just two doses. Lowering cholesterol is important because it can decrease the risk of heart problems. Nearly 80% of patients reached their cholesterol goals, demonstrating the treatment's effectiveness.
Overall, inclisiran has been safely used by many people for several years. For those considering joining a trial, this suggests the treatment has maintained a good safety record so far.12345Why do researchers think this study treatment might be promising?
Unlike the standard of care for cardiovascular disease, which often includes statins like atorvastatin or other cholesterol-lowering drugs, inclisiran stands out with its unique mechanism of action. Inclisiran works by using small interfering RNA (siRNA) to target and degrade PCSK9 mRNA in the liver, leading to a significant reduction in LDL cholesterol levels. This approach allows for a more sustained effect, with injections needed only twice a year, which is a major convenience compared to the daily dosing required by most current treatments. Researchers are excited about inclisiran because it offers a novel way to manage cholesterol levels, potentially improving both patient adherence and health outcomes.
What evidence suggests that inclisiran might be an effective treatment for cardiovascular disease?
Research has shown that inclisiran, which participants in this trial may receive, can lower "bad" cholesterol (LDL cholesterol) by about 50%. Studies have found that reducing LDL cholesterol with inclisiran decreases the risk of major heart problems, such as heart attacks or strokes. Nearly 80% of patients reach their cholesterol goals with inclisiran. This evidence suggests that inclisiran could help prevent serious heart issues in people with heart disease.12567
Who Is on the Research Team?
Novartis Pharmaceuticals
Principal Investigator
Novartis Pharmaceuticals
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive inclisiran sodium 300 mg subcutaneously on Day 1, Month 3, and every 6 months thereafter
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Inclisiran
Trial Overview
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Subcutaneous injection
Subcutaneous injection
Inclisiran is already approved in European Union, United States, China for the following indications:
- Primary hypercholesterolemia (heterozygous familial and non-familial)
- Mixed dyslipidemia
- Heterozygous familial hypercholesterolemia (HeFH)
- Clinical atherosclerotic cardiovascular disease (ASCVD)
- Primary hypercholesterolemia
- Primary hypercholesterolemia (heterozygous familial and non-familial)
- Mixed dyslipidemia
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD
Citations
Current usage of inclisiran for cardiovascular diseases
Across pivotal trials, including ORION-9, ORION-10, and ORION-11, inclisiran demonstrated LDL-C reductions of approximately 50%, with effects ...
Two Phase 3 Trials of Inclisiran in Patients with Elevated ...
In one trial, the LDL cholesterol level was lowered by 52.6% at 180 days after two doses of 284 mg of inclisiran (equivalent to 300 mg of inclisiran sodium) ...
Novartis presents new long-term Leqvio® (inclisiran) data ...
Nearly 80% (78.4% (95% CI: 76.8, 80.0)) of patients reached their pre-specified LDL-C targets**, and on average, LDL-C levels were reduced by ...
Abstract 4139801: Predicted efficacy of Inclisiran compared ...
Data quantifying how lowering LDL-C with inclisiran translates into a reduced risk of major adverse cardiovascular events (MACE) and comparison ...
Inclisiran in Cardiovascular Health: A Review of ...
In the ORION-7 study, inclisiran demonstrated similar lipid-lowering effects across patients with mild, moderate, and severe renal impairment, with drug ...
Study Details | NCT03705234 | A Randomized Trial ...
The study aims to find out if a new cholesterol-lowering injection (inclisiran) safely lowers the risk of heart attacks and strokes in people who have already ...
Safety and Tolerability of Inclisiran for Treatment ...
Long-term treatment with inclisiran was well tolerated in a diverse population, without new safety signals, supporting the safety of inclisiran in patients ...
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