title: The Basilar Artery International Cooperation Study (BASICS): study protocol for a randomised controlled trial.
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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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).
authors.affiliation: Department of Radiology, St Antonius Hospital, PO Box 2500, Nieuwegein EM 3430, The Netherlands.
authors.forename: Erik J R J
authors.initials: EJ
authors.lastname: van der Hoeven
authors.forename: Wouter J
authors.initials: WJ
authors.lastname: Schonewille
authors.forename: Jan Albert
authors.initials: JA
authors.lastname: Vos
authors.forename: Ale
authors.initials: A
authors.lastname: Algra
authors.forename: Heinrich J
authors.initials: HJ
authors.lastname: Audebert
authors.forename: Eivind
authors.initials: E
authors.lastname: Berge
authors.forename: Alfonso
authors.initials: A
authors.lastname: Ciccone
authors.forename: Mikael
authors.initials: M
authors.lastname: Mazighi
authors.forename: Patrik
authors.initials: P
authors.lastname: Michel
authors.forename: Keith W
authors.initials: KW
authors.lastname: Muir
authors.forename: Víctor
authors.initials: V
authors.lastname: Obach
authors.forename: Volker
authors.initials: V
authors.lastname: Puetz
authors.forename: Cristanne A C
authors.initials: CA
authors.lastname: Wijman
authors.forename: Andrea
authors.initials: A
authors.lastname: Zini
authors.forename: Jaap L
authors.initials: JL
authors.lastname: Kappelle
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001488:Basilar Artery / Q000000981:diagnostic imaging; D002533:Cerebral Angiography / Q000379:methods; D002985:Clinical Protocols; D005343:Fibrinolytic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007261:Infusions, Intra-Arterial; D007262:Infusions, Intravenous; D018810:Magnetic Resonance Angiography; D008875:Middle Aged; D009426:Netherlands; D011237:Predictive Value of Tests; D012042:Registries; D012107:Research Design; D015912:Thrombolytic Therapy / Q000009:adverse effects; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D014715:Vertebrobasilar Insufficiency / Q000175:diagnosis / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D005343:Fibrinolytic Agents