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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
Health authority
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.

Study Design


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
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