RecruitingPHASE3INTERVENTIONAL

Induced Hypertension in Acute PRogrESsive Perforating Artery Stroke Using Peripheral Dilute noREpinephrine

This study, called PRESSURE, investigates a new way to treat a specific type of stroke that affects small blood vessels in the brain. Some people with this kind of stroke experience a worsening of their symptoms shortly after it happens. Researchers are testing if gently increasing blood pressure using a medicine called norepinephrine, given through a drip, can improve blood flow to the brain and help people recover better. This is a large study that compares this treatment to usual care. The goal is to find out if this approach is both effective and safe for patients experiencing this type of stroke and worsening symptoms.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

University Hospital, Bordeaux

Enrolment target

358

Start

28 Nov 2024

Estimated completion

28 Nov 2027

Stroke, Acute Stroke, Ischemic

What is this study about?

Imagine your brain needs a constant supply of fresh blood, just like a garden needs water. In a stroke, part of that supply gets cut off. For some specific types of strokes, especially those affecting very tiny blood vessels deep inside the brain, the symptoms can sometimes get worse in the hours or days after the stroke first happened. This might be because the affected brain tissue isn't getting enough blood flow.

This study is looking into a treatment that aims to gently increase blood pressure. The idea is that by slightly raising blood pressure, more blood might be pushed into the areas of the brain that are struggling after the stroke. The researchers are using a common medicine called norepinephrine, which is given through a drip into a vein, to achieve this mild blood pressure increase.

The PRESSURE study is a carefully designed research project. Doctors want to compare this experimental treatment with the standard care that patients usually receive. They will be closely watching to see if the increased blood pressure helps reduce the worsening of symptoms, improves recovery, and if it's a safe approach for patients.

Key takeaways

This study is for a specific type of stroke, where symptoms might worsen.
It tests if gently raising blood pressure with medicine helps brain recovery.
Norepinephrine is given through a drip and closely monitored.
Participation involves careful checks and follow-up.
You might receive the new treatment or standard care.
You can stop participating at any time.

Who may be eligible?

To be considered for this study, you would generally need to have had a specific type of stroke (affecting the perforating arteries, visible on your brain MRI) within the last three days. Importantly, your stroke symptoms would need to have worsened since the stroke, or been fluctuating, within six hours of being considered for the study.

You would also need to be at least 18 years old and have health insurance. For women who are able to have children, it's important to be using effective contraception during the study. There are also specific reasons why someone might not be able to join, such as if you have a high risk of bleeding in the brain, had a severe disability before your stroke, or have certain other medical conditions or are taking particular medications.

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.

Did you have a stroke in the last three days?
Did your stroke symptoms get worse or fluctuate recently?
Are you 18 years old or older?
Are you able to have a brain MRI scan?
Do you have a low risk of bleeding in your brain?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first undergo a careful check-up to make sure the treatment is suitable for you. If you meet all the criteria, you would then be randomly assigned to either receive the study treatment (norepinephrine given through an intravenous drip) or continue with standard medical care. This drip would be carefully monitored by doctors and nurses. You would have regular assessments, including brain scans and checks of your neurological function, to see how you are responding. The overall duration of your participation in the study, including follow-up appointments, would be explained in detail by the research team.

Potential risks and benefits

Participating in a study like this could potentially lead to benefits, such as improved recovery from your stroke, if the treatment proves to be effective. However, there are no guarantees, and it's also possible that the treatment may not help you personally. As with any medical treatment, there are potential risks and side effects associated with norepinephrine, and these would be fully explained to you. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

CHU de Bordeaux
Verified postcode
Bordeaux, France· Recruiting

Common questions

What is a 'perforating artery stroke'?

It's a type of stroke that happens when blood flow is blocked in very small, deep blood vessels within the brain.

What does 'early neurological deterioration' mean?

This means that the stroke symptoms you are experiencing have become worse or have changed significantly shortly after the stroke happened.

What is norepinephrine?

Norepinephrine is a medicine often used in hospitals to gently increase blood pressure and improve blood flow in certain medical situations.

Will I definitely receive the new treatment?

No, participants are randomly assigned to either receive the study treatment or standard care, so it's a 50/50 chance.

Is this study safe?

The study is carefully designed by medical experts, and your health will be closely monitored throughout. All potential risks will be discussed with you.

How to find out more

Pauline RENOU

pauline.renou@chu-bordeaux.fr 05-56-79-55-20 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.