Basilar Artery International Cooperation Study

Stroke Clinical Trial

— BASICS  

Official title:

Basilar Artery International Cooperation Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01717755
• Other study ID #: NL33550.100.10
• Secondary ID: NHS2010B1512010-
• Status: Recruiting
• Phase: N/A
• First received: October 23, 2012
• Last updated: January 16, 2018
• Start date: October 2011
• Est. completion date: January 2020

Study information

• Verified date: January 2018
• Source: St. Antonius Hospital
• Contact: Wouter Schonewille, MD
• Phone: +31 6 41285149
• Email: w.schonewille[@]antoniusziekenhuis.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 282
• Est. completion date: January 2020
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria

• Symptoms and signs compatible with ischemia in the basilar artery territory.

• Basilar artery occlusion (BAO) confirmed by CTA or MRA.

• Age 18 years or older (i.e., candidates must have had their 18th birthday).

• If IVT is considered as part of best medical management, IVT should be started within 4.5 hours of estimated time of BAO. (Estimated time of BAO is defined as time of onset of acute symptoms leading to clinical diagnosis of BAO or if not known last time patient was seen normal prior to onset of these symptoms).

• Initiation of IAT should be feasible within 6 hours of estimated time of BAO.

Exclusion criteria

• Pre-existing dependency with mRankin =3.

• Females of childbearing potential who are known to be pregnant and/or lactating or who have positive pregnancy tests on admission.

• Patients who require hemodialysis or peritoneal dialysis.

• Other serious, advanced, or terminal illness.

• Any other condition that the investigator feels would pose a significant hazard to the patient if thrombolytic therapy is initiated.

• Current participation in another research drug treatment protocol (patient cannot start another experimental agent until after 90 days).

• Informed consent is not or cannot be obtained.

Imaging exclusion criteria

• High-density lesion consistent with hemorrhage of any degree.

• Significant cerebellar mass effect or acute hydrocephalus.

• Bilateral extended brainstem ischemia.

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Basilar Artery Embolism
• Basilar Artery Occlusion
• Basilar Artery Thrombosis
• Cerebrovascular Disorders
• Embolism
• Stroke
• Stroke of Basilar Artery
• Thrombosis

Intervention

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.

Locations

Country	Name	City	State
Brazil	Fortaleza General Hospital	Fortaleza
Brazil	Hospital das Clinicas de Ribeirao Preto	Ribeirão Preto
Germany	Klinikum Augsburg	Augsburg
Germany	Berlin Charite Hospital	Berlin
Germany	Dresden University Hospital	Dresden
Germany	University Medical Center Mannheim	Mannheim
Germany	Oberschwabenklinik	Ravensburg
Italy	Bergamo Hospital	Bergamo
Italy	Genova Hospital	Genua
Italy	University Hospital Modena	Modena
Italy	Santa Corona Hospital	Pietra Ligure
Italy	Roma Umberto I	Rome
Italy	Varese Hospital	Varese
Netherlands	Academic Medical Center	Amsterdam	Noord-Holland
Netherlands	Rijnstate	Arnhem	Gelderland
Netherlands	University Medical Center Groningen	Groningen
Netherlands	Leiden University Hospital	Leiden
Netherlands	Academic Hospital Maastricht	Maastricht	Limburg
Netherlands	St. Antonius Hospital	Nieuwegein	Utrecht
Netherlands	Erasmus Medical Center	Rotterdam
Netherlands	Haga Hospital	The Hague
Netherlands	MCH Westeinde	The Hague	Zuid-Holland
Netherlands	St. Elisabeth Hospital	Tilburg	Noord Brabant
Netherlands	Universitary Medical Center Utrecht	Utrecht
Norway	University Hospital North Norway	Tromso
Norway	St. Olavs Hospital Trondheim	Trondheim
Switzerland	University Hospital of Lausanne	Lausanne	Vaud

Sponsors (2)

Lead Sponsor	Collaborator
Erik van der Hoeven	BASICS Study Group

Countries where clinical trial is conducted

Brazil,  Germany,  Italy,  Netherlands,  Norway,  Switzerland, 

References & Publications (8)

Arnold M, Fischer U, Compter A, Gralla J, Findling O, Mattle HP, Kappelle LJ, Tanne D, Algra A, Schonewille WJ; BASICS Study Group. Acute basilar artery occlusion in the Basilar Artery International Cooperation Study: does gender matter? Stroke. 2010 Nov;41(11):2693-6. doi: 10.1161/STROKEAHA.110.594036. Epub 2010 Oct 14. — View Citation

Greving JP, Schonewille WJ, Wijman CA, Michel P, Kappelle LJ, Algra A; BASICS Study Group. Predicting outcome after acute basilar artery occlusion based on admission characteristics. Neurology. 2012 Apr 3;78(14):1058-63. doi: 10.1212/WNL.0b013e31824e8f40. Epub 2012 Mar 21. — View Citation

Puetz V, Khomenko A, Hill MD, Dzialowski I, Michel P, Weimar C, Wijman CA, Mattle HP, Engelter ST, Muir KW, Pfefferkorn T, Tanne D, Szabo K, Kappelle LJ, Algra A, von Kummer R, Demchuk AM, Schonewille WJ; Basilar Artery International Cooperation Study (BASICS) Group. Extent of hypoattenuation on CT angiography source images in basilar artery occlusion: prognostic value in the Basilar Artery International Cooperation Study. Stroke. 2011 Dec;42(12):3454-9. doi: 10.1161/STROKEAHA.111.622175. Epub 2011 Sep 29. — View Citation

Schonewille W, Wijman C, Michel P; BASICS investigators. Treatment and clinical outcome in patients with basilar artery occlusion. Stroke. 2006 Sep;37(9):2206; author reply 2207. Epub 2006 Aug 10. — View Citation

Schonewille WJ, Wijman CA, Michel P, Algra A, Kappelle LJ; BASICS Study Group. The basilar artery international cooperation study (BASICS). Int J Stroke. 2007 Aug;2(3):220-3. doi: 10.1111/j.1747-4949.2007.00145.x. — View Citation

Schonewille WJ, Wijman CA, Michel P, Rueckert CM, Weimar C, Mattle HP, Engelter ST, Tanne D, Muir KW, Molina CA, Thijs V, Audebert H, Pfefferkorn T, Szabo K, Lindsberg PJ, de Freitas G, Kappelle LJ, Algra A; BASICS study group. Treatment and outcomes of acute basilar artery occlusion in the Basilar Artery International Cooperation Study (BASICS): a prospective registry study. Lancet Neurol. 2009 Aug;8(8):724-30. doi: 10.1016/S1474-4422(09)70173-5. Epub 2009 Jul 3. — View Citation

Vergouwen MD, Algra A, Pfefferkorn T, Weimar C, Rueckert CM, Thijs V, Kappelle LJ, Schonewille WJ; Basilar Artery International Cooperation Study (BASICS) Study Group. Time is brain(stem) in basilar artery occlusion. Stroke. 2012 Nov;43(11):3003-6. doi: 10.1161/STROKEAHA.112.666867. Epub 2012 Sep 18. — View Citation

Vergouwen MD, Compter A, Tanne D, Engelter ST, Audebert H, Thijs V, de Freitas G, Algra A, Jaap Kappelle L, Schonewille WJ. Outcomes of basilar artery occlusion in patients aged 75 years or older in the Basilar Artery International Cooperation Study. J Neurol. 2012 Nov;259(11):2341-6. doi: 10.1007/s00415-012-6498-2. Epub 2012 Apr 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Recanalization	Recanalization at 24 hours ± 6 hours, by CT angiography.	24 hours ± 6 hours
Other	Volume of cerebral infarction	Volume of cerebral infarction on NCCT and CTA source images.	24 hours ± 6 hours
Other	SICH	Symptomatic intracranial hemorrhage at 24 hours CT imaging ± 6 hours.	24 hours ± 6 hours.
Other	Mortality	Mortality at 90 days.	90 days
Primary	Favourable outcome	Favourable outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-3.	day 90
Secondary	Excellent outcome	Excellent outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-2.	day 90
Secondary	Modified Rankin Score	Modified Rankin Score - not dichotomized.	day 90
Secondary	NIHSS	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.	pre IVT, pre randomization, 24h post treatment
Secondary	EQ-5D	EQ-5D (quality of life) at day 90 and at 12 months.	day 90 and 12 months

External Links

•   Website BASICS trial