TY - JOUR
T1 - A multicentre, randomized, double-blinded, placebo-controlled Phase III study to investigate EXtending the time for Thrombolysis in Emergency Neurological Deficits (EXTEND)
AU - Ma, Henry
AU - Parsons, Mark
AU - Christensen, Soren
AU - Campbell, Bruce
AU - Churilov, Leonid
AU - Connelly, Alan
AU - Yan, Bernard
AU - Bladin, Chris
AU - Phan, Thanh
AU - Barber, Alan
AU - Read, Stephen
AU - Hankey, Graeme
AU - Markus, Romesh
AU - Wijeratne, Tissa
AU - Grimley, Rohan
AU - Mahant, Neil
AU - Kleinig, Timothy
AU - Sturm, Jonathan
AU - Lee, Andrew
AU - Blacker, David
AU - Gerraty, Richard
AU - Krause, Martin
AU - Desmond, Patricia
AU - McBride, Simon
AU - Carey, Leanne
AU - Howells, David
AU - Hsu, Chung
AU - Davis, Stephen
AU - Donnan, Geoffrey
PY - 2012/1
Y1 - 2012/1
N2 - Background and hypothesis: Thrombolytic therapy with tissue plasminogen activator is effective for acute ischaemic stroke within 4·5h of onset. Patients who wake up with stroke are generally ineligible for stroke thrombolysis. We hypothesized that ischaemic stroke patients with significant penumbral mismatch on either magnetic resonance imaging or computer tomography at three- (or 4·5 depending on local guidelines) to nine-hours from stroke onset, or patients with wake-up stroke within nine-hours from midpoint of sleep duration, would have improved clinical outcomes when given tissue plasminogen activator compared to placebo. Study design: EXtending the time for Thrombolysis in Emergency Neurological Deficits is an investigator-driven, Phase III, randomized, multicentre, double-blind, placebo-controlled study. Ischaemic stroke patients presenting after the three- or 4·5-h treatment window for tissue plasminogen activator and within nine-hours of stroke onset or with wake-up stroke within nine-hours from the midpoint of sleep duration, who fulfil clinical (National Institutes of Health Stroke Score ≥4-26 and prestroke modified Rankin Scale <2) will undergo magnetic resonance imaging or computer tomography. Patients who also meet imaging criteria (infarct core volume <70ml, perfusion lesion:infarct core mismatch ratio >1·2, and absolute mismatch >10ml) will be randomized to either tissue plasminogen activator or placebo. Study outcome: The primary outcome measure will be modified Rankin Scale 0-1 at day 90. Clinical secondary outcomes include categorical shift in modified Rankin Scale at 90 days, reduction in the National Institutes of Health Stroke Score by 8 or more points or reaching 0-1 at day 90, recurrent stroke, or death. Imaging secondary outcomes will include symptomatic intracranial haemorrhage, reperfusion and or recanalization at 24h and infarct growth at day 90.
AB - Background and hypothesis: Thrombolytic therapy with tissue plasminogen activator is effective for acute ischaemic stroke within 4·5h of onset. Patients who wake up with stroke are generally ineligible for stroke thrombolysis. We hypothesized that ischaemic stroke patients with significant penumbral mismatch on either magnetic resonance imaging or computer tomography at three- (or 4·5 depending on local guidelines) to nine-hours from stroke onset, or patients with wake-up stroke within nine-hours from midpoint of sleep duration, would have improved clinical outcomes when given tissue plasminogen activator compared to placebo. Study design: EXtending the time for Thrombolysis in Emergency Neurological Deficits is an investigator-driven, Phase III, randomized, multicentre, double-blind, placebo-controlled study. Ischaemic stroke patients presenting after the three- or 4·5-h treatment window for tissue plasminogen activator and within nine-hours of stroke onset or with wake-up stroke within nine-hours from the midpoint of sleep duration, who fulfil clinical (National Institutes of Health Stroke Score ≥4-26 and prestroke modified Rankin Scale <2) will undergo magnetic resonance imaging or computer tomography. Patients who also meet imaging criteria (infarct core volume <70ml, perfusion lesion:infarct core mismatch ratio >1·2, and absolute mismatch >10ml) will be randomized to either tissue plasminogen activator or placebo. Study outcome: The primary outcome measure will be modified Rankin Scale 0-1 at day 90. Clinical secondary outcomes include categorical shift in modified Rankin Scale at 90 days, reduction in the National Institutes of Health Stroke Score by 8 or more points or reaching 0-1 at day 90, recurrent stroke, or death. Imaging secondary outcomes will include symptomatic intracranial haemorrhage, reperfusion and or recanalization at 24h and infarct growth at day 90.
KW - Clinical trials
KW - EXTEND
KW - Protocols
KW - Stroke
KW - Thrombolysis
KW - Time window
UR - http://www.scopus.com/inward/record.url?scp=84155184488&partnerID=8YFLogxK
U2 - 10.1111/j.1747-4949.2011.00730.x
DO - 10.1111/j.1747-4949.2011.00730.x
M3 - Article
VL - 7
SP - 74
EP - 80
JO - International Journal of Stroke
JF - International Journal of Stroke
SN - 1747-4949
IS - 1
ER -