The Basilar Artery International Cooperation Study BASICS: study protocol for a randomised controlled trialReport as inadecuate




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Trials

, 14:200

First Online: 08 July 2013Received: 06 March 2013Accepted: 02 July 2013DOI: 10.1186-1745-6215-14-200

Cite this article as: van der Hoeven, E.J., Schonewille, W.J., Vos, J.A. et al. Trials 2013 14: 200. doi:10.1186-1745-6215-14-200

Abstract

BackgroundDespite 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.

DesignBASICS 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.

DiscussionThe 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.

KeywordsBasilar artery occlusion Basilar artery thrombosis Intra-arterial treatment Intravenous thrombolysis Stroke  Download fulltext PDF



Author: Erik JRJ van der Hoeven - Wouter J Schonewille - Jan Albert Vos - Ale Algra - Heinrich J Audebert - Eivind Berge - Alfon

Source: https://link.springer.com/







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