[EU-funded treatment study: WAKE-UP: a randomized, placebo-controlled MRI-based trial of thrombolysis in wake-up stroke].

TY - JOUR

T1 - [EU-funded treatment study: WAKE-UP: a randomized, placebo-controlled MRI-based trial of thrombolysis in wake-up stroke].

AU - Thomalla, Götz

AU - Ebinger, M

AU - Fiehler, Jens

AU - Fiebach, J B

AU - Endres, M

AU - Gerloff, Christian

PY - 2012

Y1 - 2012

N2 - Patients waking up with stroke symptoms are generally excluded from intravenous thrombolysis. It was shown that magnetic resonance imaging (MRI) can identify patients within the time window for thrombolysis (?? 4.5 h from symptom onset) by a mismatch between the acute ischemic lesion visible on diffusion-weighted imaging (DWI) but not visible on fluid-attenuated inversion recovery (FLAIR) imaging. The WAKE-UP trial is an investigator initiated, European, randomized, double-blind, placebo-controlled trial designed to test efficacy and safety of MRI-based thrombolysis with alteplase (tPA) in stroke patients with unknown time of symptom onset, e.g. due to symptom recognition on awakening. A total of 800 patients showing MRI findings of a DWI-FLAIR-mismatch will be randomized to either tPA or placebo. The primary efficacy endpoint will be favourable outcome defined by a modified Rankin scale score 0-1 at day 90. The primary safety outcome measures will be mortality and death or dependency defined by modified Rankin scale score 4-6 at 90 days. If positive the WAKE-UP trial is expected to change clinical practice and to make effective and safe treatment available for a large group of acute stroke patients currently excluded from specific acute treatment.

AB - Patients waking up with stroke symptoms are generally excluded from intravenous thrombolysis. It was shown that magnetic resonance imaging (MRI) can identify patients within the time window for thrombolysis (?? 4.5 h from symptom onset) by a mismatch between the acute ischemic lesion visible on diffusion-weighted imaging (DWI) but not visible on fluid-attenuated inversion recovery (FLAIR) imaging. The WAKE-UP trial is an investigator initiated, European, randomized, double-blind, placebo-controlled trial designed to test efficacy and safety of MRI-based thrombolysis with alteplase (tPA) in stroke patients with unknown time of symptom onset, e.g. due to symptom recognition on awakening. A total of 800 patients showing MRI findings of a DWI-FLAIR-mismatch will be randomized to either tPA or placebo. The primary efficacy endpoint will be favourable outcome defined by a modified Rankin scale score 0-1 at day 90. The primary safety outcome measures will be mortality and death or dependency defined by modified Rankin scale score 4-6 at 90 days. If positive the WAKE-UP trial is expected to change clinical practice and to make effective and safe treatment available for a large group of acute stroke patients currently excluded from specific acute treatment.

KW - Adult

KW - Humans

KW - Male

KW - Aged

KW - Female

KW - Middle Aged

KW - Aged, 80 and over

KW - Adolescent

KW - Young Adult

KW - Treatment Outcome

KW - Europe

KW - Double-Blind Method

KW - Placebo Effect

KW - Diffusion Magnetic Resonance Imaging/economics/methods

KW - European Union/economics

KW - Fibrinolytic Agents/economics/therapeutic use

KW - Stroke/diagnosis/drug therapy

KW - Thrombolytic Therapy/economics

KW - Adult

KW - Humans

KW - Male

KW - Aged

KW - Female

KW - Middle Aged

KW - Aged, 80 and over

KW - Adolescent

KW - Young Adult

KW - Treatment Outcome

KW - Europe

KW - Double-Blind Method

KW - Placebo Effect

KW - Diffusion Magnetic Resonance Imaging/economics/methods

KW - European Union/economics

KW - Fibrinolytic Agents/economics/therapeutic use

KW - Stroke/diagnosis/drug therapy

KW - Thrombolytic Therapy/economics

M3 - SCORING: Zeitschriftenaufsatz

VL - 83

SP - 1241

EP - 1251

JO - NERVENARZT

JF - NERVENARZT

SN - 0028-2804

IS - 10

M1 - 10

ER -