Acute ischemic stroke (AIS) Circulatory System Stroke, not specified as haemorrhage or infarction
Conditions
Interventions
Participants will receive a single dose of tenecteplase (RO5490263), 0.25 mg/kg, as an intravenous (IV) bolus injection, on Day 1.
Sponsors
Roche (United States)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age =18 years at the time of signing the Informed Consent Form 2. Clinical diagnosis of AIS based on signs and symptoms consistent with the diagnosis of an acute anterior circulation ischemic stroke, the persistence of neurologic deficit(s), and findings on computed tomographic (CT) scan or magnetic resonance imaging (MRI) with gradient echo sequences (GRE) sequence of the brain supportive of an AIS diagnosis 3. Time from symptom onset to study drug administration is <4.5 hours
Exclusion criteria
Exclusion criteria: 1. Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 30 days after tenecteplase administration 2. Active internal bleeding; evidence of intracranial haemorrhage on neuroimaging at screening 3. Gastrointestinal haemorrhage within 21 days of screening 4. Known hereditary or acquired haemorrhagic diathesis or coagulation factor deficiency 5. Use of one of the novel oral anticoagulants, such as direct thrombin inhibitors or direct factor Xa inhibitors, within the last 48 hours (e.g., dabigatran, rivaroxaban, apixaban, edoxaban) 6. Treatment with a thrombolytic within the last 3 months prior to dosing 7. Intracranial neoplasm (except small meningioma), arteriovenous malformation, or aneurysm 8. History of malignancy, including solid tumour and haematological malignancies, except basal cell carcinoma, in situ squamous cell carcinoma of the skin, and in situ carcinoma of the cervix that has been previously completely excised with documented, clear margins 9. Severe, uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg) 10. Clot retrieval attempted using a neurothrombectomy device prior to dosing 11. History of acute ischemic stroke in the last 90 days 12. History of haemorrhagic stroke 13. Intracranial or intraspinal surgery or trauma within 2 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Plasma concentration of tenecteplase measured from blood samples taken prior to tenecteplase administration and then at 20, 120, 360 minutes, and 24 hours after a single IV bolus administration of tenecteplase 2. Pharmacokinetic parameters derived from the plasma concentration-time profile measured from blood samples taken prior to tenecteplase administration and then at 20, 120, 360 minutes, and 24 hours after a single IV bolus administration of tenecteplase | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Biomarker concentration measured from blood samples taken prior to tenecteplase administration and then at 20, 120, 360 minutes, and 24 hours after a single IV bolus administration of tenecteplase 2. Percentage of participants with adverse events (AEs) and severity of AEs determined according to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE V5.0) from screening up to the end of the study (approximately 9 months) | — |
Countries
United States of America
Contacts
Public ContactJohn Stephens
Outcome results
None listed