Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

MIVAR - Milrinone Infusion for VAsospam treatment in subarachnoid hemoRrhage

This research study, called MIVAR, is investigating a medicine named Milrinone for patients who have experienced a specific type of stroke called a subarachnoid haemorrhage (SAH), caused by a burst blood vessel in the brain. After this type of stroke, blood vessels can sometimes narrow, a problem known as vasospasm, which can cause further brain damage. The study wants to find out if giving Milrinone can help reduce this narrowing and ultimately improve how well patients recover. Researchers will be looking at patients' overall health and independence three months after their stroke. The study is in its final stages of testing, meaning it's comparing the new treatment against standard care to confirm its effectiveness.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Centre Hospitalier Universitaire D'Angers

Enrolment target

370

Start

19 Aug 2024

aneurysmal subarachnoid hemorrhage with a vasospasm

What is this study about?

This study, known as MIVAR, is looking for better ways to help people who have had a serious type of stroke called a subarachnoid haemorrhage. This happens when a blood vessel in the brain bursts, causing bleeding. A common and serious problem after this type of stroke is called 'vasospasm', where the blood vessels in the brain can tighten or narrow. This can reduce blood flow to parts of the brain and cause further damage, affecting a person's recovery.

The MIVAR study is testing a medicine called Milrinone. Doctors want to see if Milrinone can help stop or reduce this vasospasm, and in turn, lead to a better recovery for patients. They will be carefully checking how well patients are doing three months after their stroke, especially their ability to do everyday tasks and live independently. This is a very important step in finding possible new treatments to improve the lives of people affected by this challenging condition.

Researchers will also be looking at many other things, like how long people stay in hospital, their quality of life, and what brain scans show about the effect of the treatment. This helps them get a complete picture of how Milrinone might work and if it's safe to use.

Key takeaways

This study is testing a drug called Milrinone for bleeding strokes.
It aims to prevent a problem called 'vasospasm' after the stroke.
Researchers want to see if it improves recovery at 3 months.
It's a Phase III study, meaning it's in the later stages of testing.
Participation involves receiving the drug and follow-up assessments.

Who may be eligible?

To be able to join this study, people need to be adults, aged 18 or older. The study is open to both men and women.

The most important requirement is that you must have recently had a specific type of stroke called an aneurysmal subarachnoid haemorrhage, and doctors must suspect you are developing or are at risk of developing vasospasm. This is the condition the treatment is designed to help.

There will be other specific medical conditions or treatments that might mean someone can't join the study, to make sure it's safe for everyone involved and that the results are clear. Your doctor will be able to explain all these details and check if you are a good fit for the study.

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 18 years old or older?
Have you recently had an aneurysmal subarachnoid haemorrhage?
Are doctors concerned about or treating you for vasospasm?
Are you able to participate in follow-up medical checks?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the study medication, Milrinone, as an infusion. Doctors will closely monitor you in the intensive care unit. Over the next few months, there will be several follow-up assessments. These will include check-ups to see how you are recovering, possibly some brain scans, and questionnaires about your quality of life. The main aim is to see how you are doing at 3 months and 6 months after your stroke. This careful monitoring helps the doctors understand if the treatment is working and if it is safe. The exact number of visits and tests will be explained in detail by the study team.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from receiving a new treatment that could improve your recovery from a subarachnoid haemorrhage. However, there's always a possibility that the treatment might not work or could have side effects, which the medical team will explain in full detail. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is a subarachnoid haemorrhage?

It's a serious type of bleeding stroke that happens when a blood vessel in the brain bursts, causing bleeding around the brain surface.

What is vasospasm?

After a subarachnoid haemorrhage, blood vessels in the brain can sometimes narrow or tighten, reducing blood flow. This is called vasospasm.

What is Milrinone?

Milrinone is the specific medicine being tested in this study to see if it can help prevent or treat vasospasm.

How long will the study last for me?

The main recovery checks for the study are at 3 months and 6 months after your stroke, but the hospital stay and initial treatment phase would be much shorter.

Will I get normal medical care if I join?

Yes, you will continue to receive all the usual medical care for your condition, in addition to the study treatment.