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ARTEMIDA Trial (A Randomized Trial of Efficacy, 12 Months International Double-Blind Actovegin): A Randomized Controlled Trial to Assess the Efficacy of Actovegin in Poststroke Cognitive Impairment

BACKGROUND AND PURPOSE—: Poststroke cognitive impairment is a debilitating consequence of stroke. The aim of this study was to assess whether Actovegin confers cognitive benefit in patients who have had an ischemic stroke. METHODS—: This was a 12-month, parallel-group, randomized, multicenter, doubl...

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Autores principales: Guekht, Alla, Skoog, Ingmar, Edmundson, Sally, Zakharov, Vladimir, Korczyn, Amos D.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Lippincott Williams & Wilkins 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5404405/
https://www.ncbi.nlm.nih.gov/pubmed/28432265
http://dx.doi.org/10.1161/STROKEAHA.116.014321
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author Guekht, Alla
Skoog, Ingmar
Edmundson, Sally
Zakharov, Vladimir
Korczyn, Amos D.
author_facet Guekht, Alla
Skoog, Ingmar
Edmundson, Sally
Zakharov, Vladimir
Korczyn, Amos D.
author_sort Guekht, Alla
collection PubMed
description BACKGROUND AND PURPOSE—: Poststroke cognitive impairment is a debilitating consequence of stroke. The aim of this study was to assess whether Actovegin confers cognitive benefit in patients who have had an ischemic stroke. METHODS—: This was a 12-month, parallel-group, randomized, multicenter, double-blind, placebo-controlled study. Eligible patients were ≥60 years of age with a Montreal Cognitive Assessment test score of ≤25 points. Patients were randomized into 2 groups within 1 week of acute supratentorial ischemic stroke in a 1:1 ratio: Actovegin (a deproteinized hemoderivative of calf blood, 2000 mg/d for ≤20 intravenous infusions followed by 1200 mg/d orally) or placebo for 6 months. Patients were treated in accordance with standard clinical practice for a further 6 months. The primary end point was the change from baseline in Alzheimer’s Disease Assessment Scale, cognitive subscale, extended version at 6 months. RESULTS—: Two-hundred forty-eight patients were randomized to Actovegin and 255 patients to placebo. At month 6, the least squares mean change from baseline in Alzheimer’s Disease Assessment Scale, cognitive subscale, extended version was −6.8 for Actovegin and −4.6 for placebo; the estimated treatment difference was −2.3 (95% confidence interval, −3.9, −0.7; P=0.005). Recurrent ischemic stroke was the most frequently reported serious adverse event, with a nonsignificantly higher number for Actovegin versus placebo. CONCLUSIONS—: Actovegin had a beneficial effect on cognitive outcomes in patients with poststroke cognitive impairment. The safety experience was consistent with the known safety and tolerability profile of the drug. These results warrant confirmation in additional robustly designed studies. CLINICAL TRIAL REGISTRATION—: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01582854.
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spelling pubmed-54044052017-04-27 ARTEMIDA Trial (A Randomized Trial of Efficacy, 12 Months International Double-Blind Actovegin): A Randomized Controlled Trial to Assess the Efficacy of Actovegin in Poststroke Cognitive Impairment Guekht, Alla Skoog, Ingmar Edmundson, Sally Zakharov, Vladimir Korczyn, Amos D. Stroke Original Contributions BACKGROUND AND PURPOSE—: Poststroke cognitive impairment is a debilitating consequence of stroke. The aim of this study was to assess whether Actovegin confers cognitive benefit in patients who have had an ischemic stroke. METHODS—: This was a 12-month, parallel-group, randomized, multicenter, double-blind, placebo-controlled study. Eligible patients were ≥60 years of age with a Montreal Cognitive Assessment test score of ≤25 points. Patients were randomized into 2 groups within 1 week of acute supratentorial ischemic stroke in a 1:1 ratio: Actovegin (a deproteinized hemoderivative of calf blood, 2000 mg/d for ≤20 intravenous infusions followed by 1200 mg/d orally) or placebo for 6 months. Patients were treated in accordance with standard clinical practice for a further 6 months. The primary end point was the change from baseline in Alzheimer’s Disease Assessment Scale, cognitive subscale, extended version at 6 months. RESULTS—: Two-hundred forty-eight patients were randomized to Actovegin and 255 patients to placebo. At month 6, the least squares mean change from baseline in Alzheimer’s Disease Assessment Scale, cognitive subscale, extended version was −6.8 for Actovegin and −4.6 for placebo; the estimated treatment difference was −2.3 (95% confidence interval, −3.9, −0.7; P=0.005). Recurrent ischemic stroke was the most frequently reported serious adverse event, with a nonsignificantly higher number for Actovegin versus placebo. CONCLUSIONS—: Actovegin had a beneficial effect on cognitive outcomes in patients with poststroke cognitive impairment. The safety experience was consistent with the known safety and tolerability profile of the drug. These results warrant confirmation in additional robustly designed studies. CLINICAL TRIAL REGISTRATION—: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01582854. Lippincott Williams & Wilkins 2017-05 2017-04-24 /pmc/articles/PMC5404405/ /pubmed/28432265 http://dx.doi.org/10.1161/STROKEAHA.116.014321 Text en © 2017 The Authors. Stroke is published on behalf of the American Heart Association, Inc., by Wolters Kluwer Health, Inc. This is an open access article under the terms of the Creative Commons Attribution Non-Commercial-NoDerivs (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use, distribution, and reproduction in any medium, provided that the original work is properly cited, the use is noncommercial, and no modifications or adaptations are made.
spellingShingle Original Contributions
Guekht, Alla
Skoog, Ingmar
Edmundson, Sally
Zakharov, Vladimir
Korczyn, Amos D.
ARTEMIDA Trial (A Randomized Trial of Efficacy, 12 Months International Double-Blind Actovegin): A Randomized Controlled Trial to Assess the Efficacy of Actovegin in Poststroke Cognitive Impairment
title ARTEMIDA Trial (A Randomized Trial of Efficacy, 12 Months International Double-Blind Actovegin): A Randomized Controlled Trial to Assess the Efficacy of Actovegin in Poststroke Cognitive Impairment
title_full ARTEMIDA Trial (A Randomized Trial of Efficacy, 12 Months International Double-Blind Actovegin): A Randomized Controlled Trial to Assess the Efficacy of Actovegin in Poststroke Cognitive Impairment
title_fullStr ARTEMIDA Trial (A Randomized Trial of Efficacy, 12 Months International Double-Blind Actovegin): A Randomized Controlled Trial to Assess the Efficacy of Actovegin in Poststroke Cognitive Impairment
title_full_unstemmed ARTEMIDA Trial (A Randomized Trial of Efficacy, 12 Months International Double-Blind Actovegin): A Randomized Controlled Trial to Assess the Efficacy of Actovegin in Poststroke Cognitive Impairment
title_short ARTEMIDA Trial (A Randomized Trial of Efficacy, 12 Months International Double-Blind Actovegin): A Randomized Controlled Trial to Assess the Efficacy of Actovegin in Poststroke Cognitive Impairment
title_sort artemida trial (a randomized trial of efficacy, 12 months international double-blind actovegin): a randomized controlled trial to assess the efficacy of actovegin in poststroke cognitive impairment
topic Original Contributions
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5404405/
https://www.ncbi.nlm.nih.gov/pubmed/28432265
http://dx.doi.org/10.1161/STROKEAHA.116.014321
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