Basilar Artery International Cooperation Study (BASICS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by St. Antonius Hospital
BASICS Study Group
Information provided by (Responsible Party):
Erik van der Hoeven, St. Antonius Hospital Identifier:
First received: October 23, 2012
Last updated: November 17, 2015
Last verified: November 2015

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.

Condition Intervention Phase
Basilar Artery Thrombosis
Basilar Artery Embolism
Stroke of Basilar Artery
Cerebrovascular Disorders
Other: Intra-arterial treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Basilar Artery International Cooperation Study

Further study details as provided by St. Antonius Hospital:

Primary Outcome Measures:
  • Favourable outcome [ Time Frame: day 90 ] [ Designated as safety issue: No ]
    Favourable outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-3.

Secondary Outcome Measures:
  • Excellent outcome [ Time Frame: day 90 ] [ Designated as safety issue: No ]
    Excellent outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-2.

  • Modified Rankin Score [ Time Frame: day 90 ] [ Designated as safety issue: No ]
    Modified Rankin Score - not dichotomized.

  • NIHSS [ Time Frame: pre IVT, pre randomization, 24h post treatment ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    EQ-5D (quality of life) at day 90 and at 12 months.

Other Outcome Measures:
  • Recanalization [ Time Frame: 24 hours ± 6 hours ] [ Designated as safety issue: No ]
    Recanalization at 24 hours ± 6 hours, by CT angiography.

  • Volume of cerebral infarction [ Time Frame: 24 hours ± 6 hours ] [ Designated as safety issue: No ]
    Volume of cerebral infarction on NCCT and CTA source images.

  • SICH [ Time Frame: 24 hours ± 6 hours. ] [ Designated as safety issue: Yes ]
    Symptomatic intracranial hemorrhage at 24 hours CT imaging ± 6 hours.

  • Mortality [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    Mortality at 90 days.

Estimated Enrollment: 750
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)
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01717755

Contact: Wouter Schonewille, MD +31 6 41285149
Contact: Erik van der Hoeven, MD +31 6 47490060

Berlin Charite Hospital Recruiting
Berlin, Germany
Principal Investigator: Heinrich Audebert, MD, PhD         
Dresden University Hospital Recruiting
Dresden, Germany
Principal Investigator: Volker Puetz, MD, PhD         
University Medical Center Mannheim Recruiting
Mannheim, Germany
Principal Investigator: Kristina Szabo, MD, PhD         
Oberschwabenklinik Recruiting
Ravensburg, Germany
Principal Investigator: Christina Rückert, MD, PhD         
Bergamo Hospital Recruiting
Bergamo, Italy
Principal Investigator: Bruno Censori, MD, PhD         
Genova Hospital Recruiting
Genua, Italy
Principal Investigator: Laura Malfatto, MD, PhD         
University Hospital Modena Recruiting
Modena, Italy, 41100
Principal Investigator: Andrea Zini, MD, PhD         
Roma Umberto I Recruiting
Rome, Italy
Principal Investigator: Manuela De Michele, MD, PhD         
Varese Hospital Recruiting
Varese, Italy
Principal Investigator: M.L. DeLodovici, MD, PhD         
Rijnstate Recruiting
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         
MCH Westeinde Recruiting
The Hague, Zuid-Holland, Netherlands, 2512 VA
Principal Investigator: Jelis Boiten, MD, PhD         
University Medical Center Groningen Recruiting
Groningen, Netherlands
Principal Investigator: Maarten Uyttenboogaart, MD, PhD         
Leiden University Hospital Recruiting
Leiden, Netherlands
Principal Investigator: Marieke Wermer, MD, PhD         
Haga Hospital Recruiting
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
Tromso, Norway
Principal Investigator: Stein Harald Johnsen         
St. Olavs Hospital Trondheim Recruiting
Trondheim, Norway
Principal Investigator: Gitta Rohweder, MD, PhD         
University Hospital of Lausanne Recruiting
Lausanne, Vaud, Switzerland, CH-1011
Principal Investigator: Patrik Michel, MD, PhD         
Sponsors and Collaborators
Erik van der Hoeven
BASICS Study Group
Principal Investigator: W J Schonewille, MD St. Antonius Hospital Nieuwegein
  More Information

Additional Information:

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Erik van der Hoeven, E.J.R.J. van der Hoeven, MD, St. Antonius Hospital Identifier: NCT01717755     History of Changes
Other Study ID Numbers: NL33550.100.10, NHS2010B151, 2010-023507-95
Study First Received: October 23, 2012
Last Updated: November 17, 2015
Health Authority: Switzerland: Swissmedic
Italy: The Italian Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Norway: Norwegian Medicines Agency

Keywords provided by St. Antonius Hospital:

Additional relevant MeSH terms:
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases processed this record on December 01, 2015