What side effects are associated with this type of intervention?

Common treatments for Coronary Artery Disease (CAD) that focus on reducing LDL cholesterol, such as Inclisiran, PCSK9 inhibitors (evolocumab, alirocumab), statins, and ezetimibe, have a range of side effects. Inclisiran and PCSK9 inhibitors are generally well-tolerated but can cause mild injection site reactions (e.g., pain, erythema, bruising) and, rarely, hypersensitivity reactions like rash or urticaria. Statins are known for muscle-related side effects, including myalgia and, in rare cases, rhabdomyolysis, as well as potential liver enzyme elevations. Ezetimibe is usually well-tolerated but can occasionally cause gastrointestinal symptoms such as diarrhea. Overall, these treatments are considered safe with manageable side effects for most patients.

What prior FDA approvals exist?

The FDA has approved several treatments for Coronary Artery Disease that focus on lowering LDL cholesterol. Notably, PCSK9 inhibitors such as alirocumab and evolocumab have been approved and are effective in reducing LDL-C levels. These drugs work by inhibiting the PCSK9 protein, which increases the liver's ability to remove LDL cholesterol from the blood. Inclisiran, currently under study, uses RNA interference to achieve a similar outcome by targeting the production of PCSK9, thereby reducing LDL cholesterol levels. This approach represents a novel mechanism compared to traditional statins and PCSK9 inhibitors.

What other types of research exist?

Promising alternatives to Inclisiran for reducing LDL cholesterol in CAD patients include PCSK9 inhibitors such as Evolocumab and Alirocumab, which have shown long-term efficacy and safety. Additionally, antisense oligonucleotides like Inotersen and other RNA interference therapies such as Vutrisiran are also potential options. These therapies have demonstrated significant LDL cholesterol reduction and benefits in clinical trials.

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siRNA

Inclisiran + Statins for Coronary Artery Disease (V-PLAQUE Trial)

Q: What is the mechanism of action of this treatment?

Common treatments for Coronary Artery Disease (CAD) focus on reducing LDL cholesterol, a key factor in managing the disease. Inclisiran uses RNA interference to inhibit PCSK9 synthesis, increasing LDL receptors in the liver to clear LDL cholesterol from the bloodstream. PCSK9 inhibitors like alirocumab and evolocumab also target and inhibit PCSK9, while statins inhibit HMG-CoA reductase to reduce cholesterol synthesis. Ezetimibe inhibits cholesterol absorption in the intestine. These treatments are vital for CAD patients as high LDL levels contribute to atherosclerotic plaque formation, leading to heart attacks and other cardiovascular events.

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

At the Baseline Visit, participants must be on a stable dose of maximally tolerated statin therapy

Male or female ≥18 years or ≤80 years of age at signing of informed consent

Must not have

Systolic Left Ventricle Ejection Fraction <30% at the Screening Visit

History of Peripheral Artery Disease (PAD) meeting specific criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to month 24

Awards & highlights

Pivotal Trial

Summary

This trial is testing inclisiran, an injectable medication, to see if it can reduce plaque in heart arteries of patients with non-obstructive coronary artery disease who have not had previous heart events. Inclisiran works by lowering 'bad' cholesterol levels in the blood.

Who is the study for?

This trial is for adults aged 18-80 with non-obstructive coronary artery disease (NOCAD) and no past heart events. They must be on a stable dose of the highest tolerated statin therapy, have specific LDL cholesterol levels, and confirmed NOCAD via CCTA scans without severe hypertension, liver disease, or history of cardiovascular events.

What is being tested?

The study tests if inclisiran plus maximum tolerated statins can slow down plaque buildup in heart vessels compared to placebo. Participants' plaque levels are measured using CCTA at the start and after 24 months to see if there's any difference between the two groups.

What are the potential side effects?

While not specified here, common side effects of drugs like inclisiran may include injection site reactions such as pain or swelling, flu-like symptoms including fever and chills, nausea, muscle aches, allergic reactions, and possibly liver enzyme changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am on a stable dose of the highest statin therapy I can tolerate.

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I am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My heart's pumping ability is significantly reduced.

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I have a history of Peripheral Artery Disease.

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My kidney function is not normal, as confirmed by a specific test.

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My heart condition severely limits my daily activities.

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I have a history of heart problems, including a heart attack or surgery to improve blood flow to my heart.

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I am scheduled for a procedure to improve blood flow to my heart.

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I have a current liver condition.

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I have a heart condition.

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My high blood pressure is not under control.

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I have had a stroke that wasn't due to a specific condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to month 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to month 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to month 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage change in total coronary atheroma volume

Secondary study objectives

Percentage change in LDL-C

Dental Plaque

Percentage of participants with progression, regression, or no change of total plaque atheroma volume

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 / 12Eligibility 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

Common treatments for Coronary Artery Disease (CAD) focus on reducing LDL cholesterol, a key factor in managing the disease. Inclisiran uses RNA interference to inhibit PCSK9 synthesis, increasing LDL receptors in the liver to clear LDL cholesterol from the bloodstream. PCSK9 inhibitors like alirocumab and evolocumab also target and inhibit PCSK9, while statins inhibit HMG-CoA reductase to reduce cholesterol synthesis. Ezetimibe inhibits cholesterol absorption in the intestine. These treatments are vital for CAD patients as high LDL levels contribute to atherosclerotic plaque formation, leading to heart attacks and other cardiovascular events.

Inclisiran for the Treatment of Heterozygous Familial Hypercholesterolemia.HDL hypothesis: where do we stand now?