Home > Publications Database > Effect of IV Thrombolysis With Alteplase in Patients With Vessel Occlusion in the WAKE-UP Trial. > print

001     274044
005     20250412100028.0
024 7 _ |a 10.1212/WNL.0000000000209871
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100 1 _ |a Galinovic, Ivana
|0 0000-0003-4904-8251
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245 _ _ |a Effect of IV Thrombolysis With Alteplase in Patients With Vessel Occlusion in the WAKE-UP Trial.
260 _ _ |a [Erscheinungsort nicht ermittelbar]
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520 _ _ |a Data from randomized trials on the treatment effect of pure thrombolysis in patients with vessel occlusion are lacking. We examined data from a corresponding subsample of patients from the multicenter, randomized, placebo-controlled WAKE-UP trial to determine whether MRI-guided IV thrombolysis with alteplase in unknown-onset ischemic stroke benefits patients presenting with vessel occlusion.Patients with an acute ischemic lesion visible on MRI diffusion-weighted imaging but no marked parenchymal hyperintensity on fluid-attenuated inversion recovery images were randomized to treatment with IV alteplase or placebo. The primary end point was a favorable outcome defined by a modified Rankin Scale score of 0-1 at 90 days after stroke. We investigated the interaction between vessel status and treatment effect using an unconditional logistic regression model. Treatment effects (adjusted odds ratio [aOR]) and their 95% CI were compared in patients with and without any vessel occlusion (AVO) and large vessel occlusion (LVO).185 patients (mean age 64.5 years, 46% female, median NIH Stroke Scale score 9, median time between last seen well and MRI 10.26 hours) received treatment and presented with an occlusion. 98 (20%) had LVO (defined as occlusion of the internal carotid artery, middle cerebral artery trunk, or combination). A favorable outcome was observed in 30 of 94 patients with AVO (31.9%) in the alteplase group and in 18 of 91 (19.8%) in the placebo group (aOR 2.04, 95% CI 1.00-4.18). In the subgroup of patients with LVO, a favorable outcome was observed in 16 of 53 (30.2%) in the alteplase group and in 7 of 44 (15.9%) in the placebo group (aOR 2.08, 95% CI 0.71-6.10). Treatment with alteplase was associated with higher odds of favorable outcomes with no heterogeneity of treatment effect between patients with AVO and patent vessel (p = 0.56), or between patients with and without LVO (p = 0.69).Although the WAKE-UP study was not powered to demonstrate treatment efficacy in patient subpopulations, this subgroup analysis points to a benefit of MRI-guided thrombolysis in patients with unknown-onset ischemic stroke, independent of vessel occlusion.Registered at ClinicalTrials.gov with unique identifier NCT01525290 (clinicaltrials.gov/study/NCT01525290). The study was first posted on February 2, 2012; the first patient was enrolled on September 24, 2012.This study provides Class II evidence that for patients with unknown-onset ischemic stroke with AVO, MRI-guided treatment with IV tissue plasminogen activator improves outcomes.
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650 _ 7 |a Tissue Plasminogen Activator
|0 EC 3.4.21.68
|2 NLM Chemicals
650 _ 7 |a Fibrinolytic Agents
|2 NLM Chemicals
650 _ 2 |a Humans
|2 MeSH
650 _ 2 |a Tissue Plasminogen Activator: administration & dosage
|2 MeSH
650 _ 2 |a Tissue Plasminogen Activator: therapeutic use
|2 MeSH
650 _ 2 |a Female
|2 MeSH
650 _ 2 |a Male
|2 MeSH
650 _ 2 |a Middle Aged
|2 MeSH
650 _ 2 |a Fibrinolytic Agents: administration & dosage
|2 MeSH
650 _ 2 |a Fibrinolytic Agents: therapeutic use
|2 MeSH
650 _ 2 |a Aged
|2 MeSH
650 _ 2 |a Ischemic Stroke: drug therapy
|2 MeSH
650 _ 2 |a Ischemic Stroke: diagnostic imaging
|2 MeSH
650 _ 2 |a Thrombolytic Therapy: methods
|2 MeSH
650 _ 2 |a Treatment Outcome
|2 MeSH
650 _ 2 |a Diffusion Magnetic Resonance Imaging
|2 MeSH
650 _ 2 |a Double-Blind Method
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700 1 _ |a Fiebach, Jochen B
|0 0000-0002-7936-6958
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700 1 _ |a Boutitie, Florent
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700 1 _ |a Cheng, Bastian
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700 1 _ |a Cho, Tae-Hee
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700 1 _ |a Ebinger, Martin
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700 1 _ |a Endres, Matthias
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700 1 _ |a Enzinger, Christian
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700 1 _ |a Fiehler, Jens
|0 0000-0001-8533-7478
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700 1 _ |a Ford, Ian
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700 1 _ |a Gregori, Johannes
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700 1 _ |a Günther, Matthias
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700 1 _ |a Lemmens, Robin
|0 0000-0002-4948-5956
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700 1 _ |a Muir, Keith W
|0 0000-0001-9535-022X
|b 13
700 1 _ |a Nighoghossian, N.
|b 14
700 1 _ |a Roy, Pascal
|0 0000-0003-3837-3198
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700 1 _ |a Simonsen, Claus Z
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700 1 _ |a Thijs, Vincent N
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700 1 _ |a Wouters, Anke
|0 0000-0001-5229-2699
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700 1 _ |a Gerloff, Christian
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700 1 _ |a Thomalla, Götz
|0 0000-0002-4785-1449
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700 1 _ |a Pedraza, Salvador
|0 0000-0003-2517-4413
|b 21
700 1 _ |a Investigators, for WAKE-UP
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773 _ _ |a 10.1212/WNL.0000000000209871
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