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siRNA
Inclisiran + Statins for Coronary Artery Disease (V-PLAQUE 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
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 belowSelect...
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:Select...
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
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
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?
Inclisiran for the Treatment of Heterozygous Familial Hypercholesterolemia.HDL hypothesis: where do we stand now?
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Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,917 Previous Clinical Trials
4,253,584 Total Patients Enrolled
8 Trials studying Coronary Artery Disease
15,471 Patients Enrolled for Coronary Artery Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart scan shows significant plaque but good blood flow and no past heart events.Participants may have already been identified based on certain heart imaging tests showing specific results.Your cholesterol levels need to meet certain standards when you haven't eaten for a while, depending on whether you are taking statin medication or not.My heart's pumping ability is significantly reduced.I have a history of Peripheral Artery Disease.I am on a stable dose of the highest statin therapy I can tolerate.My kidney function is not normal, as confirmed by a specific test.My heart condition severely limits my daily activities.I have a history of heart problems, including a heart attack or surgery to improve blood flow to my heart.Your cholesterol level is too high when you haven't eaten for a while, according to the local lab test.You have a pacemaker or implantable cardioverter-defibrillator (ICD) already implanted in your body.You can't have a CCTA scan or if you've had it, the results don't meet the standards.I am scheduled for a procedure to improve blood flow to my heart.My recent heart scan can be used for this study.I have a current liver condition.I am between 18 and 80 years old.I have a heart condition.My high blood pressure is not under control.I have a narrowed artery by more than 50% but my blood flow test shows less than 0.8.I have had a stroke that wasn't due to a specific condition.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Inclisiran sodium
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: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.