Actively Recruiting
A Study of TAK-755 in Adults With Acute Ischemic Stroke
Led by Takeda · Updated on 2026-04-20
222
Participants Needed
1
Research Sites
86 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Acute ischemic stroke (AIS) is a medical emergency that happens because of a sudden stop of blood flow to a part of the brain. This happens when a blood clot forms within the vessel (known as thrombotic occlusion) or a clot originating from somewhere else blocks a blood vessel (known as embolic occlusion). Strokes can cause serious health problems, death, and affect one's quality of life. To reduce long-term damage, it is important to restore blood flow to the brain as soon as possible. The main aim of this study is to check how safe TAK-755 is, and how well adults with AIS tolerate it. Other aims are to check how well TAK-755 helps participants to manage their everyday activities and to understand whether it helps reduce the seriousness of their stroke symptoms when compared to placebo. A placebo looks like TAK-755, but does not have any medicine in it, to make sure participants do not know which treatment they are taking. The participants will receive TAK-755 or placebo once; afterwards, their health will be monitored for about 3 months (90 days). All participants, regardless of their assignment to either TAK-755 or placebo, will receive the usual treatment for AIS as per the hospital's normal practice.
CONDITIONS
Official Title
A Study of TAK-755 in Adults With Acute Ischemic Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant or legally authorized representative has provided informed consent before any trial procedures.
- Age between 18 and 80 years at the time of informed consent.
- Clinical diagnosis of acute ischemic stroke.
- Stroke symptoms started within 24 hours before enrollment; wake-up strokes allowed if last known well within 24 hours.
- National Institutes of Health Stroke Scale score between 6 and 25.
- Modified Rankin Scale score less than 2 before stroke, indicating no significant disability.
- Signs and symptoms of anterior circulation stroke.
- Imaging shows causative acute ischemic stroke occlusion in specified brain arteries.
- Imaging shows salvageable brain tissue on CT or MRI.
You will not qualify if you...
- Weight over 130 kg or under 40 kg.
- History of severe traumatic brain injury in past 90 days.
- History of intracranial hemorrhage.
- History of intracranial tumor except small meningioma.
- Stroke within past 90 days.
- Intracranial or intraspinal surgery within past 90 days.
- Major surgery or severe trauma within past 14 days.
- History of cerebral amyloid angiopathy.
- Systemic malignancy except locally excised skin carcinoma with clear margins.
- Serious advanced or terminal illness with life expectancy under 1 year.
- Participation in other interventional trials within past 90 days.
- Known life-threatening allergic reaction to TAK-755 or its components.
- Prior TAK-755 treatment.
- Caplacizumab use in past 30 days.
- Use of von Willebrand factor products in past 14 days.
- Conditions preventing understanding of trial nature or consequences.
- Prior thrombolytic treatment for current stroke.
- Eligible for intravenous thrombolysis or endovascular thrombectomy for current stroke.
- Seizure at stroke onset.
- Persistently high blood pressure before randomization (systolic ≥185 mmHg or diastolic ≥110 mmHg).
- Blood glucose under 50 mg/dL or over 400 mg/dL.
- Active uncontrolled bleeding or bleeding disorders.
- Unable to undergo MRI or CT.
- Rapidly improving stroke symptoms.
- Chronic causative intracranial occlusion.
- Total occlusion of extracranial internal carotid artery.
- Evidence of septic emboli or bacterial endocarditis.
- Other significant diseases posing risk as judged by investigator.
- Pregnancy, lactation, or inability to comply with birth control or abstinence.
- Poor quality imaging or significant brain swelling or midline shift.
- Occlusion in more than one vascular territory.
- Acute or chronic intracranial hemorrhage.
- Extensive early ischemic changes in more than one-third of middle cerebral artery territory.
- Intracranial tumor (except small meningioma), cerebral aneurysm, or arteriovenous malformation.
- Platelet count below 50,000/mm³.
- Unable or unwilling to cooperate with trial procedures.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Honor Health
Scottsdale, Arizona, United States, 85251
Actively Recruiting
Research Team
T
Takeda Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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