EU-geförderte Therapiestudie WAKE-UP
Standard
EU-geförderte Therapiestudie WAKE-UP : Eine randomisierte, placebokontrollierte, MRT-basierte Thrombolysestudie bei "wake-up stroke". / Thomalla, G; Ebinger, M; Fiehler, J; Fiebach, J B; Endres, M; Gerloff, C.
in: NERVENARZT, Jahrgang 83, Nr. 10, 01.10.2012, S. 1241-51.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
Harvard
APA
Vancouver
Bibtex
}
RIS
TY - JOUR
T1 - EU-geförderte Therapiestudie WAKE-UP
T2 - Eine randomisierte, placebokontrollierte, MRT-basierte Thrombolysestudie bei "wake-up stroke"
AU - Thomalla, G
AU - Ebinger, M
AU - Fiehler, J
AU - Fiebach, J B
AU - Endres, M
AU - Gerloff, C
PY - 2012/10/1
Y1 - 2012/10/1
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 - Adolescent
KW - Adult
KW - Aged
KW - Aged, 80 and over
KW - Diffusion Magnetic Resonance Imaging
KW - Double-Blind Method
KW - Europe
KW - European Union
KW - Female
KW - Fibrinolytic Agents
KW - Humans
KW - Male
KW - Middle Aged
KW - Placebo Effect
KW - Stroke
KW - Thrombolytic Therapy
KW - Treatment Outcome
KW - Young Adult
U2 - 10.1007/s00115-012-3532-7
DO - 10.1007/s00115-012-3532-7
M3 - SCORING: Zeitschriftenaufsatz
C2 - 23015193
VL - 83
SP - 1241
EP - 1251
JO - NERVENARZT
JF - NERVENARZT
SN - 0028-2804
IS - 10
ER -
