Determining the Optimal Dose of Tenecteplase Before Endovascular Therapy for Ischaemic Stroke (EXTEND-IA TNK Part 2)

• Status: Completed
• Trial end date: 2020-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients presenting to the emergency department with acute ischemic stroke, who are eligible for standard intravenous thrombolysis within 4.5 hours of stroke onset will be assessed for major vessel occlusion to determine their eligibility for randomization into the trial. If the patient gives informed consent they will be randomised 50:50 using central computerised allocation to either 0.4mg/kg or 0.25mg/kg intravenous tenecteplase before all participants undergo endovascular thrombectomy. The trial is prospective, randomised, open-label, blinded endpoint (PROBE) design.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neuroscience Trials Australia
• Collaborator: The Florey Institute of Neuroscience and Mental Health
• Treatments: Molecular Mechanisms of Pharmacological Action; Plasminogen; Tenecteplase; Tissue Plasminogen Activator

Criteria

Inclusion Criteria:

• Patients presenting with acute ischemic stroke eligible using standard criteria to receive IV thrombolysis within 4.5 hours of stroke onset

• Patient's age is ≥18 years

• Arterial occlusion on CTA (computed tomography angiography) or MRA (Magnetic Resonance Angiography) of the ICA, M1, M2 or basilar artery.

Exclusion Criteria:

• Intracranial hemorrhage (ICH) identified by CT or MRI

• Rapidly improving symptoms at the discretion of the investigator

• Pre-stroke mRS score of ≥ 4 (indicating previous disability)

• Hypodensity in >1/3 MCA territory or equivalent proportion of basilar artery territory on non-contrast CT

• Contra indication to imaging with contrast agents

• Any terminal illness such that patient would not be expected to survive more than 1 year

• Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.

• Pregnant women