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Multicenter Study Clinical Trial
Tenecteplase-tissue-type plasminogen activator evaluation for minor ischemic stroke with proven occlusion.
- Shelagh B Coutts, Véronique Dubuc, Jennifer Mandzia, Carol Kenney, Andrew M Demchuk, Eric E Smith, Suresh Subramaniam, Mayank Goyal, Shivanand Patil, Bijoy K Menon, Philip A Barber, Dar Dowlatshahi, Thalia... more
- From the Calgary Stroke Program, Departments of Clinical Neurosciences (S.B.C., V.D., J.M., C.K., A.M.D., E.E.S., S.S., M.G., B.K.M., P.A.B., M.D.H.), Radiology (S.B.C., A.M.D., E.E.S., M.G., S.P., B.K.M.,... more
- Stroke. 2015 Mar 1;46(3):769-74.
Background And PurposeMinor stroke and transient ischemic attack with an intracranial occlusion are associated with neurological deterioration and disability. Tenecteplase (TNK-tissue-type plasminogen activator) compared with alteplase is easier to administer, has a longer half-life, higher fibrin specificity, possibly a lower rate of intracranial hemorrhage, and may be an ideal thrombolytic agent in this population.MethodsTNK-Tissue-Type Plasminogen Activator Evaluation for Minor Ischemic Stroke With Proven Occlusion (TEMPO-1) was a multicenter, prospective, uncontrolled, TNK-tissue-type plasminogen activator dose-escalation, safety, and feasibility trial. Patients with a National Institutes of Health Stroke Scale ≤5 within 12 hours of symptom onset, intracranial arterial occlusion on computed tomographic angiography and absence of well-evolved infarction were eligible. Fifty patients were enrolled; 25 patients at a dose of 0.1 mg/kg, and 25 patients at 0.25 mg/kg. Primary outcome was the rate of drug-related serious adverse events. Secondary outcomes included recanalization and 90-day neurological outcome (modified Rankin Scale, 0-1).ResultsMedian baseline National Institutes of Health Stroke Scale was 2.5 (interquartile range, 1), and median age was 71 (interquartile range, 22) years. There were no drug-related serious adverse events in tier 1. In tier 2, there was 1 symptomatic intracranial hemorrhage (4%; 95% confidence interval, 0.01-20.0). Stroke progression occurred in 6% of cases. Overall, 66% had excellent functional outcome (modified Rankin Scale, 0-1) at 90 days. Recanalization rates were high; 0.1 mg/kg (39% complete and 17% partial), 0.25 mg/kg (52% complete and 9% partial). Complete recanalization was significantly related to excellent functional outcome (modified Rankin Scale, 0-1) at 90 days (relative risk, 1.65; 95% confidence interval, 1.09-2.5; P=0.026).ConclusionsAdministration of TNK-tissue-type plasminogen activator in minor stroke with intracranial occlusion is both feasible and safe. A larger randomized controlled trial is needed to prove that this treatment is efficacious.Clinical Trial Registration Urlhttp://www.clinicaltrials.gov. Unique identifier: NCT01654445.© 2015 American Heart Association, Inc.
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