608 Participants Needed

Inclisiran + Statins for Coronary Artery Disease

(V-PLAQUE Trial)

Recruiting at 149 trial locations
NP
Overseen ByNovartis Pharmaceuticals
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Novartis Pharmaceuticals
Must be taking: Statins
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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?

Inclisiran has been shown to be safe and well-tolerated in clinical trials, with no severe adverse effects or safety concerns reported. Mild to moderate reactions at the injection site were more common with inclisiran compared to placebo.12345

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?

NP

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

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.
See 3 more

Exclusion Criteria

My heart's pumping ability is significantly reduced.
I have a history of Peripheral Artery Disease.
My kidney function is not normal, as confirmed by a specific test.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive inclisiran or placebo in addition to maximally tolerated statin therapy

24 months
Regular visits for subcutaneous injections and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Inclisiran
  • Placebo
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Inclisiran sodiumExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Inclisiran is already approved in European Union, United States, China for the following indications:

🇪🇺
Approved in European Union as Leqvio for:
🇺🇸
Approved in United States as Leqvio for:
🇨🇳
Approved in China as Leqvio for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials
2,963
Recruited
4,275,000+
Founded
1996
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Gleevec, Cosentyx, Entresto, Kisqali
Dr. Vas Narasimhan profile image

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye profile image

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Published Research Related to This Trial

In a study of 84 patients with 89 coronary lesions, pemirolast significantly reduced the rate of restenosis after stent placement, with rates of 15.0% in the pemirolast group compared to 34.1% in the control group.
Pemirolast treatment resulted in a larger lumen cross-sectional area and smaller neointima area, suggesting it may prevent restenosis by inhibiting neointimal hyperplasia, which is the growth of tissue that can block the artery.
Preventive effect of an antiallergic drug, pemirolast potassium, on restenosis after stent placement: quantitative coronary angiography and intravascular ultrasound studies.Ohsawa, H., Noike, H., Kanai, M., et al.[2016]
In a study of 287 patients with unprotected left main coronary artery (LMCA) stenosis, those treated with drug-eluting stents (DES) had a 1-year mortality rate of 4%, compared to 11% for those who underwent coronary artery bypass grafting (CABG), indicating that PCI with DES can be a safe option for selected patients.
The study found that after the first month, mortality rates between PCI and CABG were not significantly different, suggesting that PCI with DES offers comparable short- and midterm outcomes to CABG for treating LMCA stenosis.
Coronary angioplasty in drug eluting stent era for the treatment of unprotected left main stenosis compared to coronary artery bypass grafting.Mäkikallio, TH., Niemelä, M., Kervinen, K., et al.[2010]
This study analyzed the early use of drug-eluting stents (DES) in 1833 patients undergoing percutaneous coronary intervention (PCI) in Portugal in 2003, finding that 19.1% experienced major adverse cardiac events (MACE) over a 5-year follow-up period.
The results showed that the clinical outcomes of DES use in this cohort were comparable to international registries, indicating that DES can be an effective option for patients with coronary artery disease.
Five-year clinical results of coronary angioplasty with drug-eluting stents. National initiative in strategic innovation, iNOS.Baptista, J., Teles, RC., da Silva, PC., et al.[2010]

Citations

Preventive effect of an antiallergic drug, pemirolast potassium, on restenosis after stent placement: quantitative coronary angiography and intravascular ultrasound studies. [2016]
Coronary angioplasty in drug eluting stent era for the treatment of unprotected left main stenosis compared to coronary artery bypass grafting. [2010]
Five-year clinical results of coronary angioplasty with drug-eluting stents. National initiative in strategic innovation, iNOS. [2010]
Percutaneous treatment with drug-eluting stent implantation versus bypass surgery for unprotected left main stenosis: a single-center experience. [2022]
Atorvastatin stent coating does not reduce neointimal proliferation after coronary stenting. [2018]
Inclisiran: a small interfering RNA strategy targeting PCSK9 to treat hypercholesterolemia. [2022]
Inclisiran: First Approval. [2021]
Can Clinicians Start Prescribing Inclisiran for Hypercholesterolemia Today? A Review of Clinical Studies for Internal Medicine Physicians and Endocrinologists. [2021]
Inclisiran: A Review in Hypercholesterolemia. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
New Adjunct Therapy for Elevated Lipid Levels. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
A Highly Durable RNAi Therapeutic Inhibitor of PCSK9. [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
The N-Acetylgalactosamine-conjugated small interfering RNA inclisiran can be coadministered safely with atorvastatin in cynomolgus monkeys resulting in additive low-density lipoprotein cholesterol reductions. [2023]
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