Stroke Clinical Trial
Official title:
Basilar Artery International Cooperation Study
Rationale: Recently our study group reported the results of the Basilar Artery International
Cooperation Study (BASICS), a prospective registry of patients with an acute symptomatic
basilar artery occlusion (BAO). 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. Furthermore, the often-held assumption that intra-arterial
thrombolysis (IAT) is superior to intravenous thrombolysis (IVT) in patients with an acute
symptomatic BAO is challenged by our data. The BASICS registry was observational and has all
the limitations of a non-randomised study. Interpretation of results is hampered by the lack
of a standard treatment protocol for all patients who entered the study.
Objective: Evaluate the efficacy and safety of IAT in addition to best medical management
(BMM) in patients with basilar artery occlusion.
Study design: Randomised, multi-centre, open label, controlled phase III, treatment trial.
Study population: Patients, aged 18 years and older, with CTA or MRA confirmed basilar
occlusion.
Intervention: Patients will be randomised between BMM with additional IAT versus BMM alone.
IAT has to be initiated within 6 hours from estimated time of BAO. If treated with as part of
BMM, IVT should be started within 4.5 hours of estimated time of BAO.
Main study parameters/endpoints: Favorable outcome at day 90 defined as a modified Rankin
Score (mRS - functional scale) of 0-3.
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