AuthorisedTherapeutic exploratory (Phase II)Interventional

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-755 in Acute Ischemic Stroke

An ischaemic stroke happens when a blood clot blocks blood flow to part of the brain, starving brain cells of oxygen. Standard hospital care works quickly to clear this clot, but better treatments are needed to protect brain tissue and improve recovery. This Phase 2 clinical trial investigates an experimental medicine called TAK-755. Doctors want to see if giving this medicine through a drip can help open blocked blood vessels and improve recovery. A key goal is checking safety, particularly making sure the treatment does not cause dangerous bleeding in the brain. Participants will be placed into groups by chance. One group receives TAK-755, and the other receives a dummy drug (placebo) alongside standard hospital care. Doctors will closely track each patient's brain function, recovery, and overall health over about 90 days.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Takeda Development Center Americas Inc.

Enrolment target

Start

14 Jul 2026

Acute Ischemic Stroke

What is this study about?

An ischaemic stroke is a medical emergency caused by a blood clot blocking an artery that carries blood and oxygen to the brain. When brain cells are cut off from blood, they quickly become damaged or die. Current emergency treatments aim to break up or remove the clot as fast as possible. However, many people still experience lasting disability, so doctors are looking for new medicines that can help brain tissue recover more safely.

This trial is testing an experimental drug called TAK-755. It is designed to work like a natural enzyme in the blood that breaks down sticky clot-forming proteins. Researchers hope that adding this drug to standard emergency care will help clear blocked vessels more completely and protect the brain from further damage.

The main purpose of this Phase 2 study is to test both the safety and effectiveness of the medicine. Because medicines that affect blood clots can sometimes increase the risk of bleeding, researchers will watch participants very closely in the first few days to check for any bleeding inside the brain. They will also track how well participants regain everyday abilities over the following three months.

To ensure fair results, this study is 'double-blind' and 'placebo-controlled'. This means participants will receive either TAK-755 or an inactive saline solution (placebo), and neither the patients nor their treating doctors will know which one was given until the study is finished.

Key takeaways

Tests an experimental drug called TAK-755 for acute ischaemic stroke caused by a blood clot.
Aims to check if the drug can safely restore blood flow to the brain without causing serious bleeding.
Participants receive either TAK-755 or a dummy drip (placebo) alongside usual emergency hospital care.
Health and recovery are monitored closely in hospital and through follow-up visits for roughly 90 days.
Participation is entirely voluntary and will not affect standard medical care.

Who may be eligible?

This study is designed for adults aged 18 and older who are admitted to hospital with a confirmed, sudden ischaemic stroke. Because stroke treatments must be given very quickly to work, patients must arrive at the hospital within a specific time window after their symptoms first began.

Not everyone who has a stroke can take part. People who have had a bleeding (haemorrhagic) stroke, or who have conditions that put them at a very high risk of uncontrolled bleeding, will not be eligible. The medical team will also check brain scans to confirm the type and location of the stroke.

Because a stroke can affect a person's ability to communicate or make decisions, hospital staff may speak with a family member or legal representative to discuss consent before enrolling someone in the trial.

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 aged 18 or older?
Have you been diagnosed with a sudden ischaemic stroke (caused by a clot)?
Did your stroke symptoms begin within the required emergency hospital timeframe?
Do you have no known history of severe bleeding disorders?
Are you being treated in a participating hospital stroke unit?

Answer every question to see your result.

What does participation involve?

If you or your family member take part, the trial treatment begins in the emergency hospital setting shortly after arrival. The medicine (or placebo) is given as an injection or infusion through a small plastic tube into a vein (an intravenous drip).

During the hospital stay, doctors will run regular tests to monitor recovery. These include brain scans (such as CT or MRI scans) to check the size of the stroke and look for any bleeding, along with routine blood tests, blood pressure checks, and physical examinations. Doctors will assess movement, speech, and brain function at 24 hours, 72 hours, and 5 days.

After leaving the hospital, there will be follow-up checks, usually including a key appointment around 90 days (about 3 months) after the stroke. At this visit, the team will evaluate how well you can carry out daily activities and check on your overall recovery.

Potential risks and benefits

A potential benefit of taking part is that the study medicine might help clear the clot faster and reduce stroke-related disability, though this cannot be guaranteed. The study also provides very close medical monitoring throughout your recovery. The main potential risk is bleeding, including bleeding within the brain, as well as possible allergic reactions or side effects from the injection. Taking part is completely voluntary. If you decide to withdraw, or if your representative withdraws on your behalf, your normal NHS care and treatment will not be affected in any way.

Locations (4)

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

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Unverified
Greece
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Unverified
Belgium
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Unverified
France
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Unverified
Germany

Common questions

What is the main goal of this study?

The study aims to find out if TAK-755 is safe, whether it increases the risk of brain bleeds, and if it helps stroke patients recover better over 90 days.

What is a placebo, and why is it used?

A placebo is a dummy treatment that looks identical to the real medicine but contains no active drug. It helps doctors make sure that any improvements or side effects are truly caused by the study medicine.

Will joining the study delay standard emergency stroke care?

No. Participants continue to receive standard emergency hospital care for their stroke alongside the study procedures.

How long will I be in the study?

The medicine is given in hospital during the first few days, and follow-up checks on your recovery and health continue for about 90 days.

What happens if a patient is too unwell to give consent?

In emergency stroke care, if a patient cannot communicate or make decisions, doctors follow strict legal and ethical guidelines to consult a family member or legal representative before enrolling them.