Extending the time window for intravenous thrombolysis in acute ischemic stroke using magnetic resonance imaging-based patient selection

Journal article


Publication Details

Author(s): Ringleb P, Bendszus M, Bluhmki E, Donnan G, Eschenfelder C, Fatar M, Kessler C, Molina C, Leys D, Muddegowda G, Poli S, Schellinger P, Schwab S, Serena J, Toni D, Wahlgren N, Hacke W
Journal: International Journal of Stroke
Publication year: 2019
ISSN: 1747-4930


Abstract

Background: Intravenous thrombolysis with alteplase within a time window up to 4.5 h is the only approved pharmacological treatment for acute ischemic stroke. We studied whether acute ischemic stroke patients with penumbral tissue identified on magnetic resonance imaging 4.5–9 h after symptom onset benefit from intravenous thrombolysis compared to placebo. Methods: Acute ischemic stroke patients with salvageable brain tissue identified on a magnetic resonance imaging were randomly assigned to receive standard dose alteplase or placebo. The primary end point was disability at 90 days assessed by the modified Rankin scale, which has a range of 0–6 (with 0 indicating no symptoms at all and 6 indicating death). Safety end points included death, symptomatic intracranial hemorrhage, and other serious adverse events. Results: The trial was stopped early for slow recruitment after the enrollment of 119 (61 alteplase, 58 placebo) of 264 patients planned. Median time to intravenous thrombolysis was 7 h 42 min. The primary endpoint showed no significant difference in the modified Rankin scale distribution at day 90 (odds ratio alteplase versus placebo, 1.20; 95% CI, 0.63–2.27, P = 0.58). One symptomatic intracranial hemorrhage occurred in the alteplase group. Mortality at 90 days did not differ significantly between the two groups (11.5 and 6.8%, respectively; P = 0.53). Conclusions: Intravenous alteplase administered between 4.5 and 9 h after the onset of symptoms in patients with salvageable tissue did not result in a significant benefit over placebo. (Supported by Boehringer Ingelheim, Germany; ISRCTN 71616222).


FAU Authors / FAU Editors

Schwab, Stefan Prof. Dr.
Lehrstuhl für Neurologie


External institutions with authors

Boehringer Ingelheim Pharma GmbH & Co. KG
Eberhard Karls Universität Tübingen
Hospital Universitari Dr. Josep Trueta
Johannes Wesling Klinikum Minden
Karolinska University Hospital / Karolinska Universitetssjukhuset
Ruprecht-Karls-Universität Heidelberg
The University of Melbourne
Università degli studi "La Sapienza"
Universitat de Barcelona (UB) / University of Barcelona
Universität Greifswald
Universitätsklinikum Mannheim
University of Nottingham


How to cite

APA:
Ringleb, P., Bendszus, M., Bluhmki, E., Donnan, G., Eschenfelder, C., Fatar, M.,... Hacke, W. (2019). Extending the time window for intravenous thrombolysis in acute ischemic stroke using magnetic resonance imaging-based patient selection. International Journal of Stroke. https://dx.doi.org/10.1177/1747493019840938

MLA:
Ringleb, Peter, et al. "Extending the time window for intravenous thrombolysis in acute ischemic stroke using magnetic resonance imaging-based patient selection." International Journal of Stroke (2019).

BibTeX: 

Last updated on 2019-23-05 at 10:08