The Basilar Artery International Cooperation Study (BASICS): study protocol for a randomised controlled trial.

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Version: author
Serval ID
serval:BIB_4A5FAFD40BF8
Type
Article: article from journal or magazin.
Publication sub-type
Review (review): journal as complete as possible of one specific subject, written based on exhaustive analyses from published work.
Collection
Publications
Institution
Title
The Basilar Artery International Cooperation Study (BASICS): study protocol for a randomised controlled trial.
Journal
Trials
Author(s)
van der Hoeven E.J., Schonewille W.J., Vos J.A., Algra A., Audebert H.J., Berge E., Ciccone A., Mazighi M., Michel P., Muir K.W., Obach V., Puetz V., Wijman C.A., Zini A., Kappelle J.L.
Working group(s)
BASICS Study Group
ISSN
1745-6215 (Electronic)
ISSN-L
1745-6215
Publication state
Published
Issued date
2013
Volume
14
Pages
200
Language
english
Notes
Publication types: Journal Article ; Research Support, Non-U.S. Gov'tPublication Status: epublishPDF : Study protocol
Abstract
BACKGROUND: Despite recent advances in acute stroke treatment, basilar artery occlusion (BAO) is associated with a death or disability rate of close to 70%. Randomised trials have shown the safety and efficacy of intravenous thrombolysis (IVT) given within 4.5 h and have shown promising results of intra-arterial thrombolysis given within 6 h of symptom onset of acute ischaemic stroke, but these results do not directly apply to patients with an acute BAO because only few, if any, of these patients were included in randomised acute stroke trials.Recently the results of the Basilar Artery International Cooperation Study (BASICS), a prospective registry of patients with acute symptomatic BAO challenged the often-held assumption that intra-arterial treatment (IAT) is superior to IVT. Our observations in the BASICS registry underscore that we continue to lack a proven treatment modality for patients with an acute BAO and that current clinical practice varies widely.
DESIGN: BASICS is a randomised controlled, multicentre, open label, phase III intervention trial with blinded outcome assessment, investigating the efficacy and safety of additional IAT after IVT in patients with BAO. The trial targets to include 750 patients, aged 18 to 85 years, with CT angiography or MR angiography confirmed BAO treated with IVT. Patients will be randomised between additional IAT followed by optimal medical care versus optimal medical care alone. IVT has to be initiated within 4.5 h from estimated time of BAO and IAT within 6 h. The primary outcome parameter will be favourable outcome at day 90 defined as a modified Rankin Scale score of 0-3.
DISCUSSION: The BASICS registry was observational and has all the limitations of a non-randomised study. As the IAT approach becomes increasingly available and frequently utilised an adequately powered randomised controlled phase III trial investigating the added value of this therapy in patients with an acute symptomatic BAO is needed (clinicaltrials.gov: NCT01717755).
Pubmed
Web of science
Open Access
Yes
Create date
22/08/2013 16:29
Last modification date
20/08/2019 13:58
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