Is your high cholesterol level increasing your risk of having a major cardiovascular event?
Consider joining the VICTORION-1 PREVENT study
The VICTORION-1 PREVENT study will assess if an investigational drug can prevent cardiovascular events (such as heart attacks, strokes, procedures to improve blood flow, and death) in adults who are at high cardiovascular risk and who have high levels of low-density lipoprotein (LDL) cholesterol (also called ‘bad’ cholesterol), but have not yet had a major cardiovascular event.
If you have high levels of low-density lipoprotein (LDL) cholesterol (also known as ‘bad’ cholesterol) – or other risk factors such as diabetes, high blood pressure, or obesity – you are more likely to experience a heart attack or stroke. Smoking, being inactive, and getting older also increase risk.
Consistent high levels of LDL cholesterol in the blood can cause the gradual buildup of thick and fatty deposits (or plaques) on the walls of the arteries. Over time, plaques can build so much that arteries can become narrowed. Narrowed arteries can block blood flow, which can lead to a heart attack or stroke
Why is the VICTORION-1 PREVENT study important?
LDL cholesterol should be kept below a certain level. If levels get too high, making changes to our diet and lifestyle is usually recommended, but modifying lifelong habits can be challenging. Statins can also help to reduce cholesterol levels, although people can sometimes find it difficult to adhere to taking daily medications.
The VICTORION-1 PREVENT study will assess if an investigational drug can prevent cardiovascular events (such as heart attacks, strokes, procedures to improve blood flow, and death) in the future by lowering LDL cholesterol in the blood.
How does the investigational drug work?
The liver has special receptors that help to regulate LDL cholesterol levels. They work by ‘grabbing’ excess LDL cholesterol out of the blood and passing it to the liver to be broken down. Our bodies also make a
protein called PCSK9, which breaks down the LDL receptors. The fewer receptors we have, the less LDL cholesterol can be broken down.
The investigational drug works by blocking the production of PCSK9 protein, which then allows the body to remove more LDL cholesterol. So, we want to see if an investigational drug can prevent cardiovascular events in adults who are at high risk by reducing their LDL cholesterol.
We are looking for people to join this study who:
- Are 40 to 79 years of age
- Have high LDL cholesterol levels
- Have not experienced a major cardiovascular event
- Are considered high risk of having a major cardiovascular event in the future
Do not worry if you are not sure about whether you meet these criteria at the moment. We will assess each potential participant during a screening visit to make sure that they are a good fit for the study. For now, simply read this brochure and think about whether you might like to take part. And thank you for your interest in this important study.
Which study drug will I receive?
You will be randomly assigned (i.e., by chance, like the flip of a coin) to one of two groups by a computer. You have a 50% chance (1 in 2) of receiving the investigational drug and a 50% chance of receiving
placebo. A placebo looks like the investigational drug but does not contain any active ingredients. We use a placebo to be sure that any effects that happen are actually caused by the investigational drug and not some other factor(s) and/or chance.
Both the investigational drug and the placebo are given by a healthcare professional as a subcutaneous (under the skin) injection. After your first dose, you will be given a second dose after 3 months, and then
a dose every 6 months until the end of the study.
What does ‘double-blind’ mean?
This study is ‘double-blind,’ which means that neither you nor the study team will know whether you have been assigned to the investigational drug or placebo. We do this so that we can be sure that any differences seen are due to the investigational drug and not some other factor.
Frequently asked questions
How will my health be monitored?
During this study, participants will attend the clinic around once every 6 months. At clinic visits, participants will undergo assessments (such as blood samples and vital signs) to monitor their health. These assessments will vary from visit to visit.
Can I continue taking my current medications during the study?
Throughout the study, continue to take your statin – type and dose – as prescribed by your regular doctor or study doctor. Tell the study doctor about any other medications you are currently taking. Do not
start taking any new medications or changing the dose of current ones without talking to the study doctor first.
Can I get my cholesterol tested while on the study?
If you get your cholesterol tested by your regular doctor while on the study, it is important that neither you nor the study team are told the results. If you accidentally find out your LDL cholesterol level, please do not share this information with the study team. This ensures that the study results are not influenced by any other information. Throughout the study, your cholesterol will be monitored regularly by our central laboratory. The study team will be notified if you need to adjust your medication.
What are the potential benefits of taking part?
Taking part in the study may not benefit you directly, but we may learn new things that could help treat people in the future. You may also benefit from reducing your risk of having a cardiovascular event and/or lowering of your LDL cholesterol, although this cannot be guaranteed.
Taking part in the study may not benefit you directly, but we may learn new things that could help treat people in the future. You may also benefit from reducing your risk of having a cardiovascular event and/or lowering of your LDL cholesterol, although this cannot be guaranteed.
What are the potential risks of taking part?
There may be side effects (or risks) from the study drug that we do not yet know about and from some of the assessments in the study. You should tell the study team if you have any complaints or side effects, or had any other doctor visits or hospitalizations outside the study. The most common side effect of the study drug is injectionsite reactions (local skin reactions at the injection site), occurring in less than 10% of participants. As with any drug, it is possible that you may have an allergic reaction to the study drug. However, no allergic reactions were seen in three large previous clinical studies.