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
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