<A >prospective, randomized, placebo-controlled, double-blind trial about safety and efficacy of combined treatment with alteplase (rt-PA) and Cerebrolysin in acute ischaemic hemispheric stroke
Identifikátory výsledku
Kód výsledku v IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00843989%3A_____%2F13%3AE0104042" target="_blank" >RIV/00843989:_____/13:E0104042 - isvavai.cz</a>
Výsledek na webu
<a href="http://dx.doi.org/10.1111/j.1747-4949.2012.00901.x" target="_blank" >http://dx.doi.org/10.1111/j.1747-4949.2012.00901.x</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1111/j.1747-4949.2012.00901.x" target="_blank" >10.1111/j.1747-4949.2012.00901.x</a>
Alternativní jazyky
Jazyk výsledku
angličtina
Název v původním jazyce
<A >prospective, randomized, placebo-controlled, double-blind trial about safety and efficacy of combined treatment with alteplase (rt-PA) and Cerebrolysin in acute ischaemic hemispheric stroke
Popis výsledku v původním jazyce
Background The neurotrophic drug Cerebrolysin accelerated recovery and prevented acute neuronal damage in preclinical models of ischaemia. Previous clinical trials support therapeutic effects in stroke patients. The study investigated whether the combination with alteplase and Cerebrolysin is safe and can further reduce disability after acute ischaemic stroke. Methods This placebo-controlled, double-blind trial involved 119 patients with acute ischaemic hemispheric stroke, randomly assigned to a combined treatment with alteplase plus Cerebrolysin or placebo (administered 1?h after thrombolytic treatment) starting within three-hours after onset of symptoms. A daily i.v. infusion of 30?ml Cerebrolysin or placebo was given for 10 consecutive days. Primaryoutcome was the modified Rankin Scale at day 90. A sequential design with interim analyses was applied. Results The third interim analysis did not show a benefit in the modified Rankin Scale for Cerebrolysin on day 90 compared to placebo
Název v anglickém jazyce
<A >prospective, randomized, placebo-controlled, double-blind trial about safety and efficacy of combined treatment with alteplase (rt-PA) and Cerebrolysin in acute ischaemic hemispheric stroke
Popis výsledku anglicky
Background The neurotrophic drug Cerebrolysin accelerated recovery and prevented acute neuronal damage in preclinical models of ischaemia. Previous clinical trials support therapeutic effects in stroke patients. The study investigated whether the combination with alteplase and Cerebrolysin is safe and can further reduce disability after acute ischaemic stroke. Methods This placebo-controlled, double-blind trial involved 119 patients with acute ischaemic hemispheric stroke, randomly assigned to a combined treatment with alteplase plus Cerebrolysin or placebo (administered 1?h after thrombolytic treatment) starting within three-hours after onset of symptoms. A daily i.v. infusion of 30?ml Cerebrolysin or placebo was given for 10 consecutive days. Primaryoutcome was the modified Rankin Scale at day 90. A sequential design with interim analyses was applied. Results The third interim analysis did not show a benefit in the modified Rankin Scale for Cerebrolysin on day 90 compared to placebo
Klasifikace
Druh
J<sub>x</sub> - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)
CEP obor
FH - Neurologie, neurochirurgie, neurovědy
OECD FORD obor
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Návaznosti výsledku
Projekt
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Návaznosti
N - Vyzkumna aktivita podporovana z neverejnych zdroju
Ostatní
Rok uplatnění
2013
Kód důvěrnosti údajů
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Údaje specifické pro druh výsledku
Název periodika
International journal of stroke
ISSN
1747-4930
e-ISSN
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Svazek periodika
8
Číslo periodika v rámci svazku
n. 2
Stát vydavatele periodika
GB - Spojené království Velké Británie a Severního Irska
Počet stran výsledku
10
Strana od-do
"p. 95-104"
Kód UT WoS článku
000313880700008
EID výsledku v databázi Scopus
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