Active not recruitingNAINTERVENTIONAL

STREAM Trial - Statins in Multimorbid Older Adults Without Cardiovascular Disease

The STREAM study is investigating whether older adults (aged 70 and above) who have multiple health conditions and are currently taking statins to prevent heart attacks or strokes, would benefit more from continuing or stopping these medications. Whilst statins are known to help younger and middle-aged people, it's not clear if they provide the same benefits for older people with several health problems, as side effects might be more common. This research aims to understand the pros and cons of either continuing or stopping statins for this specific group. Participants will be randomly assigned to either stop or continue their statin treatment, and their health will be monitored closely.

At a glance

Status

Active not recruiting

Phase

Sponsor

Insel Gruppe AG, University Hospital Bern

Enrolment target

1,880

Start

16 Nov 2021

Estimated completion

15 Nov 2026

Statin Treatment for Primary Prevention

What is this study about?

Statins are widely used medicines that help lower cholesterol and reduce the risk of heart attacks and strokes. For many years, we've known they're very helpful for middle-aged people, both for those who've already had a heart problem (called 'secondary prevention') and for those who haven't (called 'primary prevention').

However, it's not completely clear how much statins help older adults (aged 70 and over) who haven't had a heart problem but have several other health conditions. These conditions are sometimes called 'multimorbidity'. Older adults with multiple health issues can be more affected by medication side effects and interactions between different drugs they take. Common side effects of statins can include muscle aches and pains. This study is designed to explore whether the benefits of taking statins outweigh these potential risks for this specific group of older adults.

The STREAM study is a clinical trial that aims to answer this important question. It will compare what happens when some older adults who fit this description continue taking their statins, and others stop taking them. By carefully studying these two groups, researchers hope to provide clear guidance to doctors and patients about the best approach for statin use in multimorbid older adults.

Key takeaways

This study helps understand statin use in older adults (70+) with multiple health issues.
It compares stopping statins versus continuing them.
Participation involves phone follow-ups over 1 to 4 years.
Aims to give clearer guidance for doctors and patients.
You're randomly assigned to a group, like a coin toss.

Who may be eligible?

To join this study, you must be aged 70 or over and have at least two long-term health conditions in addition to high cholesterol, for which you've been taking a statin for most of the past year.

However, you won't be able to join if you've previously had a heart attack, certain types of severe chest pain (angina), a stroke (unless it was caused by a specific heart problem like atrial fibrillation), or surgery to unblock arteries in your heart, neck, or legs. You also can't participate if you have a serious heart condition called an aortic aneurysm that's a certain size, or a genetic condition causing very high cholesterol.

Finally, if doctors believe you might not live for at least another three months, you wouldn't be able to take part. This study is open to both men and women.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 70 years old or older?
Do you have at least two other long-term health conditions (besides high cholesterol)?
Have you been taking a statin for most of the past year?
Have you NOT had a heart attack, stroke, or major heart/artery surgery?
Do you feel generally well and not have a life-limiting illness with a very short life expectancy?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to one of two groups: either you'll continue taking your statin as usual, or you'll stop taking it. It's like flipping a coin, so neither you nor your doctor can choose which group you're in. This helps make the study fair.

You'll have regular contact with the study team by phone, starting after 3 months and then yearly. These phone calls will help the researchers keep track of your health and any changes you experience. The study will last for an average of two years, but it could be shorter (at least one year) or longer (up to four years) for different people.

Potential risks and benefits

Taking part in a study like this could help us learn more about the best ways to use statins in older adults with multiple health conditions. This could benefit many people in the future. However, there are potential risks, depending on which group you're in. If you stop statins, there's a chance your risk of heart problems could go up, or it could stay the same. If you continue statins, you might still experience side effects like muscle pain or interactions with other medications. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (24)

UNIVERSITY HOSPITAL CENTER of Bordeaux
Verified postcode
Bordeaux, France
Leids Universitair Medisch Centrum
Verified postcode
Leiden, Netherlands
Klinik Barmelweid AG
Approximate
Barmelweid, Switzerland
Centre hospitalier Bienne
Verified postcode
Biel/Bienne, Switzerland
Spital Limmattal
Verified postcode
Schlieren, Switzerland
Kantonsspital Graubünden
Verified postcode
Chur, Switzerland
Luzerner Höhenklinik Montana AG
Verified postcode
Crans-Montana, Switzerland
Kantonsspital Aarau
Verified postcode
Aarau, Switzerland
Kantonsspital Baden
Verified postcode
Baden, Switzerland
Universitätsspital Basel
Verified postcode
Basel, Switzerland
Ospedale Regionale di Bellinzona e Valli
Verified postcode
Bellinzona, Switzerland
Clinic for General Internal Medicine, Bern University Hospital Bern
Verified postcode
Bern, Switzerland

Common questions

What is a statin?

A statin is a medicine often prescribed to lower cholesterol in your blood, which can help reduce your risk of heart attacks and strokes.

What does 'multimorbid' mean?

This means having several (two or more) long-term health conditions at the same time, in addition to having high cholesterol.

Why is this study only for older adults?

We already know statins help younger and middle-aged people. This study focuses on older adults (70+) because the benefits and risks of statins for them, especially those with multiple health conditions, are less clear.

What does 'randomly assigned' mean?

It means you'll be put into one of two groups (either continuing or stopping statins) by chance, like drawing names from a hat. This makes the study fair and scientific.

Can I still take other medications during the study?

Yes, you generally continue with your other medications. The study is particularly interested in how statins work alongside other treatments for people with multiple health conditions.