Around 15,000 participants from approximately 50 countries around the world are expected to take part in the VICTORION-2 PREVENT Study.
Why is the VICTORION-2 PREVENT Study being carried out? One of the aims of the VICTORION-2 PREVENT Study is to see how the investigational drug works when taken alongside your current statin – medication that lowers the level of LDL cholesterol, or ‘bad’ cholesterol, in the blood. It is hoped that this combination can safely and effectively reduce the risk of future cardiovascular events, such as strokes and heart attacks.
How does the investigational drug work?
There is a specific protein in the body that controls the amount of cholesterol in blood. The investigational drug is designed to prevent production of this protein and reduce the amount of bad cholesterol.
What will happen during the study?
This VICTORION-2 PREVENT Study could last between 3 and 6 years, depending on when you enter the study, and consists of 3 parts:
• Part 1: Screening (1–2 weeks) – at this visit, the study doctor will discuss the study and explain what participation involves. After you have read and signed the Informed Consent Form, the study doctor will ask you questions and perform tests to see if you can join the study. If your current statin does not meet the study requirements, but you are eligible to enter the statin optimisation period, your screening could last up to 8 weeks (see below).
• Part 2: Study treatment (minimum 3 years and up to 6 years) – you will now receive either the investigational drug or placebo and attend study visits for further tests.
• Part 3: Follow-up – 30 days after your last study visit, the study doctor will contact you by telephone to check on your health and well-being.
Which study drug will I receive? A computer will assign you randomly to receive either the investigational drug or placebo. You have a 50% (1 in 2) chance of receiving the investigational drug and a 50% chance of receiving placebo. You cannot choose which study drug to receive. Neither you nor the study doctor will know which study drug you are taking. This strategy is commonly used during studies to ensure that results from the tests are handled in an unbiased w
Criteria:I2. Male or female ≥ 40 years of age at signing of informed consent.
I3. Fasting LDL-C ≥1.8 mmol/L (70 mg/dL)
I4. At the Screening Visit, participants must be on a stable (≥4 weeks) and well-tolerated lipid lowering regimen (including e.g. with or without Ezetimibe) that must include a high intensity statin therapy with either atorvastatin ≥40 mg QD or rosuvastatin ≥20 mg QD .Participants who enter the Statin Optimization Period must satisfy all statin treatment criteria defined in Section 3.1 at the Statin Optimization Screening Visit.
I5. Established CV disease defined as ANY of the following three conditions:
a) MI: Spontaneous MI (either ST-elevation MI or non-ST-elevation MI),
b) Stroke: History of ischemic stroke (an acute episode of focal cerebral, spinal, or visual
dysfunction caused by infarction of central nervous system tissue) having occurred in
the period >4 weeks prior to the first study visit (Statin Optimization Screening Visit
or Screening Visit) documented by computerized tomography (CT) scan, Magnetic
Resonance Imaging (MRI) or other visualization method. Transient ischemic attack,
lacunar infarction or embolic stroke (not of atherosclerotic origin) are not qualifying
events.
c) Symptomatic PAD, as evidenced by either intermittent claudication with (ABI) <0.85,
prior peripheral arterial revascularization procedure, or, amputation due to
atherosclerotic disease.
Exclusion Criteria
E1. Acute coronary syndrome, ischemic stroke, peripheral arterial revascularization procedure or amputation due to atherosclerotic disease <4 weeks prior to the first study visit (defined as either the Statin Optimization Screening Visit or the Screening Visit, whichever comes first) or during the Statin Optimization or Screening periods.
E2. Planned or expected cardiac, cerebrovascular or peripheral artery surgery or revascularization within the 6 months after the first study visit.
E3. Heart failure NYHA class III or IV at the Statin Optimization Screening Visit (if applicable), the Screening Visit, or before randomization.
E4. Active liver disease defined as any known current infectious, neoplastic, or metabolic
E5. Previous (within 90 days prior to the first study visit i.e. the Statin Optimization Screening Visit or the Screening Visit) treatment with a mAb directed towards PCSK9 (e.g.,