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Tenecteplase Versus Alteplase Before Endovascular Therapy for Ischemic Stroke

Information source: Neuroscience Trials Australia
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ischemic Stroke

Intervention: Tenecteplase (Drug); Tissue Plasminogen Activator (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Neuroscience Trials Australia

Overall contact:
Bruce Campbell, MD, Phone: +61 3 9342 8443

Summary

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.

Clinical Details

Official title: Extending the Time for Thrombolysis in Emergency Neurological Deficits - Intra-Arterial Using Intravenous Tenecteplase

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Proportion of patients with substantial angiographic reperfusion (assessed as a modified Treatment In Cerebral Ischemia (mTICI) score of 2b/3 (restoration of blood flow to >50% of the affected arterial territory) at initial angiogram.

Secondary outcome:

Proportion of patients with complete angiographic reperfusion (mTICI 3) at initial angiogram.

Median percentage reperfusion at 24 hrs post stroke, adjusted for site of occlusion (CT or MR perfusion imaging).

Favourable clinical response at 3 days

Modified Rankin Scale (mRS) at 3 months

mRS 0-1 or no change from baseline at 3 months

mRS 0-2 or no change from baseline at 3 months

Symptomatic intracranial hemorrhage (SICH) assessed as a large parenchymal hematoma on CT or MR within 36hr of treatment combined with a clinical deterioration of >/= 4 points on the National Institutes of Health Stroke Scale Score (NIHSS)

Death due to any cause

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Bruce Campbell, MD, Phone: +61 3 9342 8443

Auckland Hospital, Grafton, Auckland 1001, New Zealand; Not yet recruiting
Alan Barber, Prof.
Alan Barber, Prof., Principal Investigator

John Hunter Hospital, Newcastle, New South Wales, Australia; Not yet recruiting
Ferdi Miteff, Principal Investigator

Royal North Shore Hospital, St. Leonards, New South Wales 2065, Australia; Not yet recruiting
Martin Krause, Principal Investigator

Royal Brisbane & Women's Hospital, Brisbane, Queensland, Australia; Not yet recruiting
Andrew Wong, Principal Investigator

Gold Coast University Hospital, Gold Coast, Queensland, Australia; Not yet recruiting
Monica Badve, Principal Investigator

Royal Adelaide Hospital, Adelaide, South Australia 5000, Australia; Recruiting
Timothy Kleinig, Principal Investigator

Flinders Medical Centre, Bedford Park, South Australia 5042, Australia; Not yet recruiting
Andrew Lee, Principal Investigator

Box Hill Hospital, Box Hill, Victoria 3128, Australia; Not yet recruiting
Helen Dewey, Principal Investigator

Monash Medical Centre, Clayton, Victoria 3168, Australia; Not yet recruiting
Thanh Phan, Principal Investigator

Western Heath, Footscray, Victoria 3011, Australia; Not yet recruiting
Tissa Wijeratne, Principal Investigator

Austin Hospital, Heidelberg, Victoria, Australia; Not yet recruiting
Marion Simpson, Principal Investigator

Royal Melbourne Hospital, Melbourne, Victoria 3050, Australia; Recruiting
Bruce Campbell, Principal Investigator

Additional Information

Starting date: March 2015
Last updated: April 14, 2015

Page last updated: August 23, 2015

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