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RecruitingPhase III and phase IV (Integrated)Interventional

Reperfusion with P2Y12 inhibitors in addition to mechanical thrombectomy for perfusion imaging selected acute stroke patients : a multicentric randomized controlled trial.

An ischemic stroke happens when a blood clot suddenly blocks blood flow to part of the brain. The standard emergency treatment is a procedure called mechanical thrombectomy, where doctors physically remove the clot using a tiny wire. This clinical trial is testing whether adding an intravenous medicine called Kengrexal (cangrelor) during this procedure improves recovery. Kengrexal stops blood platelets from sticking together and forming new clots in tiny blood vessels. Doctors use specialised brain scans to choose suitable adult patients. Half the patients receive the extra medicine, while the other half receive standard care. Researchers will check patients at 24 hours, perform brain scans, and assess their overall recovery and independence after three months. The study aims to see if this combined treatment is safe and helps stroke survivors return to their normal daily activities.

At a glance

Status
Recruiting
Phase
Phase III and phase IV (Integrated)
Sponsor
Fondation A De Rothschild
Enrolment target
368
Start
01 Aug 2024

What is this study about?

A stroke is a medical emergency that occurs when blood supply to part of the brain is cut off. Without oxygen and nutrients, brain cells quickly become damaged. The most common type is an ischemic stroke, caused by a blood clot lodged in an artery. In the UK, doctors often treat severe strokes by carrying out a procedure called mechanical thrombectomy. During this treatment, a specialist doctor threads a tiny tube through a blood vessel to pull the clot directly out of the brain.

While thrombectomy is very effective, tiny clots can sometimes remain or reform in smaller blood vessels, preventing the brain tissue from getting full blood flow. This trial is testing whether a medicine called Kengrexal can solve this problem. Kengrexal is a powerful, fast-acting drug given directly into a vein that stops blood cells called platelets from clumping together.

In this study, patients who arrive at the hospital with a fresh stroke will have special brain scans. If the scans show brain tissue that can still be saved, doctors will perform the thrombectomy and randomly give some patients Kengrexal alongside it. The study will track how well blood flows back into the brain immediately after the procedure and check for any swelling or bleeding on follow-up scans.

Ultimately, researchers want to see if adding Kengrexal helps more stroke survivors regain their independence. At three months after treatment, doctors will measure how easily patients can walk, take care of themselves, and carry out their daily routines. Finding better ways to restore full blood flow could improve quality of life for thousands of stroke patients.

Key takeaways

  • Tests whether adding the blood thinner Kengrexal to clot-removal surgery improves stroke recovery.
  • Aimed at adults arriving at hospital with an acute ischemic stroke.
  • Uses advanced brain scans to select patients with brain tissue that can be saved.
  • Patients are checked closely in hospital and assessed again after three months.
  • Taking part is voluntary, and safety is monitored closely by specialist stroke doctors.

Who may be eligible?

This trial is open to adults aged 18 and over who have been rushed to hospital with an acute ischemic stroke. Because stroke treatments work best early on, patients must arrive within a short time window after their symptoms first begin.

Doctors will perform advanced brain imaging scans upon arrival. These scans check whether a major blood vessel is blocked and whether there is brain tissue that can still be rescued by restoring blood flow. Only patients whose scans show they could benefit from clot removal will be invited to participate.

People may not be able to join if they have an active bleed, a very high risk of bleeding, or other medical conditions that make strong blood-thinning medicines unsafe. The hospital stroke team carefully reviews each person's scans and medical history before deciding if the study is right for them.

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.

  1. Aged 18 or older
  2. Diagnosed with an acute ischemic stroke (caused by a blood clot)
  3. Arrived at the hospital within the safe time window for emergency clot removal
  4. Brain scans confirm a blocked artery and salvageable brain tissue
  5. No medical conditions causing a high risk of dangerous bleeding
Answer every question to see your result.

What does participation involve?

Because stroke is an emergency, joining the study happens right away in the hospital. If eligible, the patient will receive standard clot-removal surgery and may also receive the trial medicine through a drip. Doctors will monitor blood pressure, brain function, and overall health very closely during the first 24 to 36 hours. Patients will also have follow-up brain scans (such as a CT scan) to check how well the brain is healing and ensure there is no bleeding. The total active hospital treatment takes a few days, followed by standard rehabilitation. Researchers will follow up with a final health assessment at three months to see how well the patient has recovered their movement and independence.

Potential risks and benefits

Taking part in this study may help restore blood flow to the brain more completely, which could lead to a better recovery and less disability. However, there is no guarantee of direct benefit. Because Kengrexal is a blood thinner, the main risk is an increased chance of bleeding, including bleeding inside the brain or bruising at the injection site. All patients will be monitored closely in an intensive or specialist stroke unit. Participation is entirely voluntary; if a patient or their family decides not to take part, or wishes to withdraw at any time, it will not affect the quality of NHS care they receive.

Locations (1)

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

Common questions

What is mechanical thrombectomy?

It is a routine emergency procedure where a doctor gently guides a thin plastic tube through an artery to pull a blood clot out of the brain.

What is Kengrexal?

Kengrexal (cangrelor) is a medicine given into a vein that stops blood cells called platelets from sticking together, helping to keep blood flowing freely.

Will every patient receive the study medicine?

No. This is a randomised trial, meaning a computer system randomly decides whether a patient receives Kengrexal or standard care alongside their clot removal.

How can consent be given during a stroke emergency?

If a patient cannot speak or decide for themselves due to the stroke, doctors will ask a family member or follow strict legal and ethical emergency research rules.

Does taking part cost anything?

No. All treatments, scans, and doctor visits related to the trial are provided free of charge through the hospital.

How to find out more

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

Interested in taking part?

Register your interest

Share your details and the research team for "Reperfusion with P2Y12 inhibitors in addition to mechanical …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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