A study to evaluate the safety, processing by the body and response of the body to tenecteplase in adults with acute ischemic stroke

Phase 1

• Conditions: Acute ischemic stroke (AIS); Circulatory System; Stroke, not specified as haemorrhage or infarction

• Registration Number: ISRCTN13376195
• Lead Sponsor: Roche (United States)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-16
• Last Update Posted: 30 May 2022
• Study Completion: 2023-02-16

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 20

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified