Acute Ischemic Stroke
Conditions
Interventions
Part A: TAK-755
Participants will receive a single intravenous (IV) infusion of TAK-755 on Day 1 of Part A. All participants will be followed for up to 90 days post treatment.
Part B: TAK-755
Partici
Sponsors
Nonomura Hidenori
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Informed Consent: 1.The participant or legally authorized representative has provided informed consent before the initiation of any trial procedures. Age: 2.18 to 90 years of age, inclusive, at the time of signing the informed consent form. Clinical Characteristics: 3.Clinical diagnosis of Acute Ischemic Stroke (AIS). 4.Onset of stroke symptoms within 24 hours of enrollment. Wake-up strokes may be included if Last Known Well is within 24 hours of enrollment; time of onset will be considered the time of Last Known Well. 5.National Institutes of Health Stroke Scale score of 6 to 25, indicating moderate to severe stroke. 6.Estimated Modified Rankin Scale score less than (<) 2 prior to AIS presentation, signifying no significant disability. 7.Signs and symptoms consistent with anterior circulation stroke. Imaging: 8.Evidence of causative AIS occlusion on imaging (intracranial internal carotid artery [ICA], M1, M2, M3, M4, A1, A2, A3). 9.Evidence of salvageable brain tissue on CT or MR imaging.
Exclusion criteria
Exclusion criteria: Medical History: 1.Weight >130 kilograms (kg) or =185 millimeters of mercury [mmHg] or diastolic >=110 mm Hg) prior to randomization. 22.Blood glucose 400 mg/dL. Current Medical Conditions: 23.Active, uncontrolled bleeding. 24.Bleeding diathesis or any other conditions that would pose significant bleeding risk. 25.Inability to undergo MRI or CT. 26.Rapidly improving AIS symptoms. 27.Chronic causative intracranial occlusion. 28.Causative total occlusion of the extracranial ICA. 29.Evidence of septic emboli or bacterial endocarditis. 30.Another clinically significant concomitant disease that may pose additional risks for the participant in the opinion of the investigator. 31.Pregnancy, lactation, or unable to comply with birth control methods or abstinence as specified in the protocol in the opinion of the investigator. Imaging: 32.Poor quality imaging that precludes interpretation according to trial protocol. 33.Evidence of significant intracranial mass effect or midline shift. 34.Evidence of occlusion in >1 vascular territory. 35.Evidence of acute or chronic intracranial hemorrhage. 36.Evidence of extensive early ischemic change estimated to be greater than one-third of the middle cerebral artery territory. 37.Evidence of intracranial tumor (except incidental, small meningioma), cerebral aneurysm, or arteriovenous malformation. Laboratory: 38.Platelet count <50,000/ cubic millimeters (mm^3). Other: 39.Identification by the investigator as being potentially unable or unwilling to cooperate with trial procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Part A and B: Percentage of Participants who Develop Symptomatic Intracranial Hemorrhage (sICH) as Defined by the Heidelberg Bleeding Classification System Time Frame: Up to 120 hours of study drug administration The Heidelberg Bleeding Classification System is used to determine whether an Intracranial Hemorrhage (ICH) is symptomatic (sICH) or asymptomatic (aICH). It uses a structured 7-step approach that integrates imaging findings with clinical deterioration. This algorithm includes anatomic description of hemorrhage, adjudication of neurological deterioration, and relatedness between ICH and clinical deterioration. Percentage of participants who develop sICH will be reported. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Part A: Percentage of Participants With Treatment-Related and Unrelated Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Time Frame: From start of study drug administration up to follow-up (up to 90 days) An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. A TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a trial intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the trial intervention or medicinal product. An SAE is defined as any untoward medical occurrence that results in death or is life-threatening or requires inpatient hospitalization or results in significant disability/incapacity or is a congenital anomaly or meets the definitions of other medically significant events. Percentage of participants with TEAEs and SAEs will be reported. 2.Part A: Percentage of Participants With Severe TEAEs Time Frame: From start of study drug administration up to follow-up (up to 90 days) A TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a trial intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the trial intervention or medicinal product. A severe TEAE is a type of AE that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Percentage of participants with severe TEAEs will be reported. 3.Part A: Percentage of Participants With Life-Threatening Adverse Events (AEs) Time Frame: From start of study drug administration up to follow-up (up to 90 days) Percentage of participants with life-threatening AEs will be reported. 4.Part A: Percentage of Participants With AE | — |
Countries
Belgium, Brazil, China, France, Germany, Greece, India, Japan, UK, US
Contacts
Public ContactContact for Clinical Trial Information
Takeda Pharmaceutical Company Limited
Outcome results
None listed