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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to month 24
Awards & highlights
V-PLAQUE Trial Summary
This trial is testing a new cholesterol-lowering drug in people with early heart disease who are also taking a statin. The goal is to see if the new drug can reduce the amount of plaque in the heart's arteries.
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.Check my eligibility
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.See study design
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.
V-PLAQUE Trial 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.
Select...
I am between 18 and 80 years old.
V-PLAQUE Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage change in total coronary atheroma volume
Secondary outcome measures
Percentage change in LDL-C
Dental Plaque
Percentage of participants with progression, regression, or no change of total plaque atheroma volume
V-PLAQUE Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Inclisiran sodiumExperimental Treatment1 Intervention
Subcutaneous injection
Group II: PlaceboPlacebo Group1 Intervention
Subcutaneous injection
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Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,857 Previous Clinical Trials
4,197,201 Total Patients Enrolled
8 Trials studying Coronary Artery Disease
15,468 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Would this research be beneficial for elderly individuals?
"This particular clinical trial is looking for individuals who are at least 18 and no older than 80."
Answered by AI
Is Inclisiran sodium 300 mg prescription safe for long-term use?
"Inclisiran sodium 300 mg is considered safe by our team at Power. This is because it has received a Phase 3 classification, signifying that there is both evidence of efficacy and multiple rounds of data supporting safety."
Answered by AI
Is there still room for more people in this study?
"The study is recruiting patients, as indicated by the information available on clinicaltrials.gov. This trial was originally posted on 7/8/2022 and has had one update on 11/7/2022."
Answered by AI
In how many different places can I enroll in this study?
"This clinical trial has 10 sites which are currently operational. They are based in Richmond, Beverly Hills and New york as well as 7 other locations. If you enroll, it would be best to choose the clinic closest to your home so that commuting is not a hassle."
Answered by AI
How many people are being given the chance to participate in this experiment?
"That is accurate, the clinical trial is still open for recruitment according to the last update on November 7th, 2022. The study was first made public on July 8th, 600 people are needed in total from 10 different locations."
Answered by AI
Who else is applying?
What state do they live in?
Florida
What site did they apply to?
Novartis Investigative Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
How responsive is this trial?
Most responsive sites:
- Novartis Investigative Site: < 48 hours
Typically responds via
Email
Average response time
- < 2 Days
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