Inclisiran + Statins for Coronary Artery Disease
(V-PLAQUE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Do I have to stop taking my current medications for this trial?
The trial does not specify if you need to stop taking your current medications. However, you must be on a stable dose of statin therapy for at least 4 weeks before the trial. If you're not on a maximally tolerated statin, you may need to go through a Statin Optimization Period.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does require participants to be on a stable dose of statin medication for at least 4 weeks before starting. If you're not on a maximally tolerated statin, you may need to adjust your statin therapy during the study.
What safety data exists for Inclisiran + Statins treatment?
Inclisiran has been evaluated in multiple clinical trials, including the ORION trials and earlier phase 1 trials. The safety profile of Inclisiran is similar to placebo, with mild to moderate, transient injection-site reactions being more frequent. No severe adverse effects, safety concerns, or fatalities directly attributable to Inclisiran were reported. It is considered safe and well-tolerated as a lipid-lowering drug.12345
Is Inclisiran safe for use in humans?
Is the drug Inclisiran a promising treatment for coronary artery disease?
Yes, Inclisiran is a promising drug for coronary artery disease because it can significantly lower bad cholesterol (LDL-C) levels, especially in people who can't reach their cholesterol goals with statins alone. It is convenient because it only needs to be taken twice a year, and it works well with statins to further reduce cholesterol.24567
How is the drug Inclisiran unique for treating coronary artery disease?
Inclisiran is unique because it is a small interfering RNA (siRNA) drug that lowers cholesterol by blocking the production of a protein called PCSK9, which is different from how traditional statins work. It is administered as a subcutaneous injection only twice a year, offering a convenient dosing schedule compared to other cholesterol-lowering treatments.24567
What data supports the idea that Inclisiran + Statins for Coronary Artery Disease is an effective drug?
The available research does not provide specific data on the effectiveness of Inclisiran + Statins for Coronary Artery Disease. Instead, it focuses on other treatments like drug-eluting stents and their benefits in coronary artery conditions. Without direct evidence from the provided studies, we cannot conclude the effectiveness of Inclisiran + Statins for this condition.89101112
Who Is on the Research Team?
Novartis Pharmaceuticals
Principal Investigator
Novartis Pharmaceuticals
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive inclisiran or placebo in addition to maximally tolerated statin therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Inclisiran
- Placebo
Inclisiran is already approved in European Union, United States, China for the following indications:
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