Basilar Artery International Cooperation Study (BASICS)
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.
|Basilar Artery Thrombosis Basilar Artery Embolism Stroke of Basilar Artery Stroke Cerebrovascular Disorders||Other: Intra-arterial treatment||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Basilar Artery International Cooperation Study|
- Favourable outcome [ Time Frame: day 90 ]Favourable outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-3.
- Excellent outcome [ Time Frame: day 90 ]Excellent outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-2.
- Modified Rankin Score [ Time Frame: day 90 ]Modified Rankin Score - not dichotomized.
- NIHSS [ Time Frame: pre IVT, pre randomization, 24h post treatment ]
National Institutes of Health Stroke Scale (NIHSS - acute assessment scale) at timepoints:
- directly pre intravenous thrombolysis
- directly pre randomization (post intravenous thrombolysis)
- at 24 hours +- 6 hours post treatment.
- EQ-5D [ Time Frame: day 90 and 12 months ]EQ-5D (quality of life) at day 90 and at 12 months.
- Recanalization [ Time Frame: 24 hours ± 6 hours ]Recanalization at 24 hours ± 6 hours, by CT angiography.
- Volume of cerebral infarction [ Time Frame: 24 hours ± 6 hours ]Volume of cerebral infarction on NCCT and CTA source images.
- SICH [ Time Frame: 24 hours ± 6 hours. ]Symptomatic intracranial hemorrhage at 24 hours CT imaging ± 6 hours.
- Mortality [ Time Frame: 90 days ]Mortality at 90 days.
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||October 2017|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
No Intervention: Best medical management.
Best medical management consists of the standard of care of patients with acute ischemic stroke according to existing local protocols and guidelines, and may include IV thrombolysis.
Experimental: Additional intra-arterial treatment.
Best medical management followed by intra-arterial treatment and maximum supportive care.
Other: Intra-arterial treatment
IA therapy has to be initiated within 6 hours of estimated time of basilar artery occlusion. If an appropriate thrombus or residual stenosis is identified, the choice of IA strategy wil be made by the treating neurointerventionalist. Choice of therapy depends on local approval and experience. If IA thrombolysis is the chosen strategy, a maximum of 22 mg of IA rt-PA or 1.500.000 Units of Urokinase may be given. Stenting is allowed in the presence of a high-grade vertebral artery stenosis or occlusion hampering adequate endovascular access to the basilar artery and in case of a residual high-grade basilar artery stenosis. The use of any other treatment strategy depends on local approval and experience, and is only allowed after prior approval of the steering committee.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01717755
|Contact: Wouter Schonewille, MD||+31 6 email@example.com|
|Contact: Erik van der Hoeven, MD||+31 6 firstname.lastname@example.org|
|Berlin Charite Hospital||Recruiting|
|Principal Investigator: Heinrich Audebert, MD, PhD|
|Dresden University Hospital||Recruiting|
|Principal Investigator: Volker Puetz, MD, PhD|
|University Medical Center Mannheim||Recruiting|
|Principal Investigator: Kristina Szabo, MD, PhD|
|Principal Investigator: Christina Rückert, MD, PhD|
|Principal Investigator: Bruno Censori, MD, PhD|
|Principal Investigator: Laura Malfatto, MD, PhD|
|University Hospital Modena||Recruiting|
|Modena, Italy, 41100|
|Principal Investigator: Andrea Zini, MD, PhD|
|Roma Umberto I||Recruiting|
|Principal Investigator: Manuela De Michele, MD, PhD|
|Principal Investigator: M.L. DeLodovici, MD, PhD|
|Arnhem, Gelderland, Netherlands, 6800 TA|
|Principal Investigator: Jeanette Hofmeijer, MD, PhD|
|Academic Hospital Maastricht||Recruiting|
|Maastricht, Limburg, Netherlands, 6229 HX|
|Principal Investigator: Julie Staals, MD, PhD|
|St. Elisabeth Hospital||Recruiting|
|Tilburg, Noord Brabant, Netherlands, 5022 GC|
|Principal Investigator: Paul de Kort, MD, PhD|
|Academic Medical Center||Recruiting|
|Amsterdam, Noord-Holland, Netherlands, 1105AZ|
|Principal Investigator: Paul Nederkoorn, MD, PhD|
|St. Antonius Hospital||Recruiting|
|Nieuwegein, Utrecht, Netherlands, 3430 EM|
|Principal Investigator: Wouter Schonewille, MD, PhD|
|The Hague, Zuid-Holland, Netherlands, 2512 VA|
|Principal Investigator: Jelis Boiten, MD, PhD|
|University Medical Center Groningen||Recruiting|
|Principal Investigator: Maarten Uyttenboogaart, MD, PhD|
|Leiden University Hospital||Recruiting|
|Principal Investigator: Marieke Wermer, MD, PhD|
|The Hague, Netherlands|
|Principal Investigator: Karlijn de Laat, MD, PhD|
|Universitary Medical Center Utrecht||Recruiting|
|Utrecht, Netherlands, 3584 CX|
|Principal Investigator: Jaap Kappelle, MD, PhD|
|University Hospital North Norway||Recruiting|
|Principal Investigator: Stein Harald Johnsen|
|St. Olavs Hospital Trondheim||Recruiting|
|Principal Investigator: Gitta Rohweder, MD, PhD|
|University Hospital of Lausanne||Recruiting|
|Lausanne, Vaud, Switzerland, CH-1011|
|Principal Investigator: Patrik Michel, MD, PhD|
|Principal Investigator:||W J Schonewille, MD||St. Antonius Hospital Nieuwegein|