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

Trials

Jaap L Kappelle^1,13  Andrea Zini⁸  Cristanne AC Wijman³  Volker Puetz⁶  Víctor Obach^1,10  Keith W Muir⁹  Patrik Michel¹  Mikael Mazighi⁷  Alfonso Ciccone²  Eivind Berge⁴  Heinrich J Audebert^1,12  Ale Algra⁵  Jan Albert Vos^1,11  Wouter J Schonewille^1,14  Erik JRJ van der Hoeven^1,11 

[1] Department of Clinical Neurosciences CHUV, BH/13/204 Rue du Bugnon 46, Lausanne, CH-1011, Switzerland;Department of Neurology and Stroke Unit, Carlo Poma Hospital, Strada Lago Paiolo 10, Mantua, 46100, Italy;Stanford University Medical Center, Stanford Stroke Center, 780 Welch Road, Suite 205, Palo Alto, CA, 94304, USA;Department of Internal Medicine, Oslo University Hospital Ullevål, Oslo, NO-0407, Norway;Julius Center for health Sciences and Patient Care, University Medical Center Utrecht, HP STR 6.131, PO Box 85500, Utrecht, GA, 3508, The Netherlands;Department of Neurology, Dresden University Stroke Centre, Technical University Dresden, Fetscherstraße 74, Dresden, 01307, Germany;Department of Neurology and Stroke Centre, Bichat University Hospital, 46 rue henri Huchard, Paris, 75018, France;Stroke Unit, Department of Neuroscience, University of Modena and Reggio Emilia, St. Agostino-Estense Hospital, Modena, AUSL, Italy;Institute of Neurosciences & Psychology, Southern General Hospital, University of Glasgow, Glasgow, G51 4TF, UK;Comprehensive Stroke Center, Hospital Clinic de Barcelona, Villarroel 170, Barcelona, 08036, Spain;Department of Radiology, St. Antonius Hospital, PO Box 2500, Nieuwegein, EM, 3430, The Netherlands;Center for Stroke Research Berlin and Department of Neurology, Charité Universitätsmedizin Berlin, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12200, Germany;Department of Neurology and Neurosurgery, Rudolf Magnus Institute for Neuroscience, University Medical Center Utrecht, HP G 03.228, PO Box 85500, Utrecht, GA, 3508, The Netherlands;Department of Neurology, St. Antonius Hospital, PO Box 2500, Nieuwegein, EM, 3430, The Netherlands

关键词: Stroke;    Intravenous thrombolysis;    Intra-arterial treatment;    Basilar artery thrombosis;    Basilar artery occlusion;   

Others  :  1093514
DOI  :  10.1186/1745-6215-14-200

 received in 2013-03-06, accepted in 2013-07-02,  发布年份 2013

【 摘 要 】

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).

【 授权许可】

   
2013 van der Hoeven et al.; licensee BioMed Central Ltd.

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