Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/19963
Title: Statistical Analysis Plan for EXtending the time for Thrombolysis in Emergency Neurological Deficits (EXTEND) trial.
Austin Authors: Churilov, Leonid ;Ma, Henry;Campbell, Bruce Cv;Davis, Stephen M;Donnan, Geoffrey A 
Affiliation: Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Australia
Department of Medicine, Monash Health, Monash University, Clayton, Victoria, Australia
The Florey Institute of Neuroscience and Mental Health, The University of Melbourne, Heidelberg, Victoria, Australia
Issue Date: Feb-2020
metadata.dc.date: 2018-12-07
Publication information: International Journal of Stroke 2020; 15(2): 231-238
Abstract: EXtending the time for Thrombolysis in Emergency Neurological Deficits (EXTEND) is a randomized, multicenter, double-blinded, placebo-controlled phase 3 trial to test the hypothesis of extending the thrombolysis time window to 9 h from stroke onset and in wake-up stroke (WUS) patients. To formulate the detailed statistical analysis plan for the EXTEND trial prior to database lock. This statistical analysis plan is based on the published and registered EXTEND trial protocol and is developed by the blinded steering committee and management team. The developed EXTEND statistical analysis plan is transparent, verifiable, and predetermined before the database lock. It is consistent with reporting standards for clinical trials and provides for clear and open reporting. Publication of a statistical analysis plan serves to reduce potential trial analysis and reporting bias and outlines pre-specified analyses to quantify the benefits and harms of extending the thrombolysis time window to 9 h from stroke onset and in wake-up stroke patients. Trial registration: ClinicalTrials.gov number NCT00887328 registered 23/Apr/2009 and NCT01580839 (EXTEND International) registered 19/Apr/2012.
URI: http://ahro.austin.org.au/austinjspui/handle/1/19963
DOI: 10.1177/1747493018816101
ORCID: 0000-0003-3632-9433
0000-0001-6324-3403
0000-0002-9807-6606
PubMed URL: 30523735
Type: Journal Article
Subjects: alteplase
computed tomography perfusion imaging
Ischaemic Stroke
penumbral mismatch
randomised trial
thrombolysis
thrombolytic therapy
time window
wake-up Stroke
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