Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Impact of Evolocumab on Major Cardiovascular Events in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke

This important study is testing a new medicine called Evolocumab. It's for adults who have a higher chance of developing heart problems, but who haven't yet had a heart attack or a stroke. The main aim is to find out if Evolocumab can reduce the risk of these serious events, including death from heart disease, heart attacks, or strokes. To do this, some people in the study will receive Evolocumab, while others will receive a 'dummy' medicine (placebo), without knowing which they are taking. We hope this research will help improve how we protect people from heart disease and stroke.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Amgen Inc.

Enrolment target

6,020

Start

08 Apr 2024

Adults at high risk of cardiovascular events without prior MI or stroke.

What is this study about?

This study is a type of research called a 'clinical trial'. It's specifically designed to see how a new medicine, called Evolocumab, affects people at high risk of heart and blood vessel problems. Think of it like this: if someone has a high chance of having a heart attack or stroke in the future, even if they haven't had one yet, this study wants to see if Evolocumab can help prevent it. The researchers are particularly interested in whether the medicine can stop or delay serious events like a heart attack, a stroke, or death related to heart disease. They will also look at events where blood flow to the heart or brain is partly blocked, needing a procedure to open it up.

To make sure the results are fair and reliable, this study is 'double-blind' and 'placebo-controlled'. 'Double-blind' means neither the patients nor their doctors will know whether they are receiving the actual medicine (Evolocumab) or a 'dummy' pill (called a placebo). A 'placebo' looks exactly like the real medicine but contains no active drug. This helps us understand if any improvements are genuinely due to the medicine and not just other factors. 'Multicenter' means the study is happening in many different hospitals or clinics, which helps gather information from a wide range of patients.

This is a 'Phase III' study, which means it's a large, final stage of testing for the medicine. If Evolocumab proves to be safe and effective in reducing heart problems, it could become a new treatment option for people with similar risks. Finding new ways to prevent heart attacks and strokes is vital for public health, and this study aims to contribute significantly to that goal.

Key takeaways

This study evaluates a new medicine, Evolocumab, for preventing heart attacks and strokes.
It's for adults at high risk of heart problems who haven't had a heart attack or stroke before.
Participants will receive either Evolocumab or a dummy medicine, without knowing which.
The study aims to see if Evolocumab reduces serious heart-related events.
It's a large, important study (Phase III) that could lead to new preventative treatments.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or over. This study is open to both men and women.

The most important health requirement is that you must be considered by doctors to be at 'high risk' of having a heart attack or stroke. However, you must *not* have had a heart attack or stroke in the past yourself. This study is specifically looking at prevention in people who are at risk, rather than treating those who have already experienced these events.

Your doctor will be able to tell you if your individual health situation and risk factors meet the specific criteria for this study. There might be other medical conditions or medicines you are taking that would mean you can't join, but your doctor will check all of these details with you.

Quick self-check

Are you 18 years old or older?
Have you been told you are at 'high risk' for heart problems?
Have you *never* had a heart attack?
Have you *never* had a stroke?
Are you able to attend regular clinic visits?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would be assigned by chance (like flipping a coin) to either receive the study medicine, Evolocumab, or a dummy medicine called a placebo. You, and your study doctor, would not know which one you are receiving.

Taking part would involve regular visits to the clinic for health checks, blood tests, and to receive your study medicine. These visits would allow the research team to monitor your health closely, check how you are responding to the treatment, and record any changes. You would also need to report any new health concerns or side effects you experience.

The study will follow you for a period to see how the medicine performs over time. The total duration of your participation would be explained fully by the study team, and it could last for several years, as serious heart events can take time to develop. You would have ongoing support from the study team throughout.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of taking part in this study is contributing to valuable medical research that could help prevent serious heart problems for many people in the future. If you receive Evolocumab, it's possible it could lower your risk of a heart attack or stroke. However, there's also a chance you might receive the placebo medicine, which has no active drug. As with any medicine, Evolocumab may have side effects, and some are not yet fully known. The study team will explain all known risks and monitor you closely for any health changes. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (22)

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Latvia
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Italy
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Estonia
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Czechia
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Finland
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Netherlands
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Hungary
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Sweden
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France
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Portugal
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Romania
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Lithuania

+10 more sites — see the official record for the full list.

Common questions

What is 'high cardiovascular risk'?

This means you have certain health conditions or lifestyle factors that make it more likely you could have a heart attack or stroke in the future, even if you haven't had one yet. Your doctor can assess your individual risk.

What is a 'placebo'?

A placebo is a 'dummy' medicine that looks like the real treatment but doesn't contain any active drug. It helps researchers fairly compare the new medicine's effects.

Will I know if I'm getting the real medicine?

No, neither you nor your study doctor will know whether you are receiving Evolocumab or the placebo. This is called a 'double-blind' study and helps keep the results unbiased.

What if I experience side effects?

The study team will monitor you closely, and you should report any new or worrying symptoms immediately. They will provide guidance and care.

How long will I be in the study?

The study involves long-term follow-up, as heart events can take time to develop. The exact duration will be explained to you by the study team, but it could be for several years.