Tenecteplase Versus Alteplase Before Endovascular Therapy for Ischemic Stroke "EXTEND-IA TNK"

Recruiting

Phase 2 Results N/A

Update History

23 Jun '17
The Summary of Purpose was updated.
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Patients presenting to the emergency department with acute ischemic stroke, who are are eligible for standard intravenous tPA therapy 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 intravenous alteplase or tenecteplase before all participants undergo intra-arterial clot retrieval. The trial is prospective, randomised, open-label, blinded endpoint (PROBE) design.
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Patients presenting to the emergency department with acute ischemic stroke, who are are eligible for standard intravenous tPA therapy within 4.5 hours of stroke onset will be assessed for "dual target" major vessel occlusion and mismatch 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 intravenous alteplase or tenecteplase before all participants undergo intra-arterial clot retrieval. The trial is prospective, randomised, open-label, blinded endpoint (PROBE) design.
The gender criteria for eligibility was updated to "All."
The eligibility criteria were updated.
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Inclusion Criteria: 1. Patients presenting with acute ischemic stroke eligible using standard criteria to receive IV thrombolysis within 4.5 hours of stroke onset 2. Patient's age is ≥18 years 3. Intra-arterial clot retrieval treatment can commence (arterial puncture) within 6 hours of stroke onset. 4. Arterial occlusion on CTA or MRA of the ICA, M1, M2 or basilar artery. Exclusion Criteria: 1. Intracranial hemorrhage (ICH) identified by CT or MRI 2. Rapidly improving symptoms at the discretion of the investigator 3. Pre-stroke mRS score of ≥ 4 (indicating previous disability) 4. Hypodensity in >1/3 MCA territory or equivalent proportion of basilar artery territory on non-contrast CT 5. Contra indication to imaging with contrast agents 6. Any terminal illness such that patient would not be expected to survive more than 1 year 7. 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. 8. Pregnant women
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Inclusion Criteria: 1. Patients presenting with acute ischemic stroke eligible using standard criteria to receive IV thrombolysis within 4.5 hours of stroke onset 2. Patient's age is ≥18 years 3. Intra-arterial clot retrieval treatment can commence (groin puncture) within 6 hours of stroke onset. Imaging inclusion criteria, Dual target: 5. Arterial occlusion on CTA or MRA of the ICA, M1, M2 or basilar artery 6. Mismatch (only applies to anterior circulation) - Using CT or MRI with a Tmax >6 second delay perfusion volume and either CT-rCBF or DWI ischemic core volume. 1. Mismatch ratio of greater than 1.2, and 2. Absolute mismatch volume of greater than 10 ml, and. 3. Ischemic core lesion volume of less than 70mL Exclusion Criteria: 1. Intracranial hemorrhage (ICH) identified by CT or MRI 2. Rapidly improving symptoms at the discretion of the investigator 3. Pre-stroke mRS score of ≥ 4 (indicating previous disability) 4. Hypodensity in >1/3 MCA territory or equivalent proportion of basilar artery territory on non-contrast CT 5. Contra indication to imaging with contrast agents 6. Any terminal illness such that patient would not be expected to survive more than 1 year 7. 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. 8. Pregnant women
23 Sep '16
A location was updated in Newcastle.
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The overall status was updated to "Recruiting" at John Hunter Hospital.
A location was updated in St. Leonards.
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The overall status was updated to "Recruiting" at Royal North Shore Hospital.
A location was updated in Brisbane.
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The overall status was updated to "Recruiting" at Royal Brisbane & Women's Hospital.
A location was updated in Gold Coast.
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The overall status was updated to "Recruiting" at Gold Coast University Hospital.
A location was updated in Box Hill.
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The overall status was updated to "Recruiting" at Box Hill Hospital.
A location was updated in Clayton.
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The overall status was updated to "Recruiting" at Monash Medical Centre.
A location was updated in Footscray.
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The overall status was updated to "Recruiting" at Western Heath.
A location was updated in Heidelberg.
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The overall status was updated to "Recruiting" at Austin Hospital.
A location was updated in Grafton.
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The overall status was updated to "Recruiting" at Auckland Hospital.
16 Apr '15
A location was updated in Gold Coast.
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The overall status was updated to "Recruiting" at Gold Coast University Hospital.
A location was updated in Adelaide.
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The overall status was updated to "Recruiting" at Royal Adelaide Hospital.
A location was updated in Melbourne.
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The overall status was updated to "Recruiting" at Royal Melbourne Hospital.