Journal Article

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

Mazighi, Mikael, Wijman, Cristanne AC, Vos, Jan Albert, Obach, Víctor, Zini, Andrea, Kappelle, Jaap L, Puetz, Volker, Berge, Eivind, Audebert, Heinrich J, Ciccone, Alfonso, van der Hoeven, Erik JRJ, Muir, Keith W, Schonewille, Wouter J, Algra, Ale, Michel, Patrik

2013

Overview

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).

• Publisher: BioMed Central,BioMed Central Ltd
• Subject: Adolescent / Adult / Aged / Aged, 80 and over / Basilar Artery - diagnostic imaging / Biomedicine / Care and treatment / Cerebral Angiography - methods / Clinical Protocols / Fibrinolytic Agents - administration & dosage / Fibrinolytic Agents - adverse effects / Health aspects / Health Sciences / Humans / Infusions, Intra-Arterial / Infusions, Intravenous / Magnetic Resonance Angiography / Medicine / Medicine & Public Health / Middle Aged / Netherlands / Predictive Value of Tests / Registries / Research Design / Statistics for Life Sciences / Stroke (Disease) / Study Protocol / Thrombolytic drugs / Thrombolytic Therapy - adverse effects / Time Factors / Tomography, X-Ray Computed / Treatment Outcome / Vertebrobasilar Insufficiency - diagnosis / Vertebrobasilar Insufficiency - drug therapy / Young Adult