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Basilar Artery International Cooperation Study (BASICS)

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ClinicalTrials.gov Identifier: NCT01717755
Recruitment Status : Unknown
Verified January 2018 by Erik van der Hoeven, St. Antonius Hospital.
Recruitment status was:  Recruiting
First Posted : October 30, 2012
Last Update Posted : January 18, 2018
Sponsor:
Collaborator:
BASICS Study Group
Information provided by (Responsible Party):
Erik van der Hoeven, St. Antonius Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Basilar Artery Thrombosis Basilar Artery Embolism Stroke of Basilar Artery Stroke Cerebrovascular Disorders Basilar Artery Occlusion Other: Intra-arterial treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 282 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Basilar Artery International Cooperation Study
Study Start Date : October 2011
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2020

Arm Intervention/treatment
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.

If treated with IVT as part of BMM, IVT should be started within 4.5 hours of estimated time of BAO.

Experimental: Additional intra-arterial treatment.
Best medical management followed by intra-arterial treatment and best medical management
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.




Primary Outcome Measures :
  1. Favourable outcome [ Time Frame: day 90 ]
    Favourable outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-3.


Secondary Outcome Measures :
  1. Excellent outcome [ Time Frame: day 90 ]
    Excellent outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-2.

  2. Modified Rankin Score [ Time Frame: day 90 ]
    Modified Rankin Score - not dichotomized.

  3. 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.

  4. EQ-5D [ Time Frame: day 90 and 12 months ]
    EQ-5D (quality of life) at day 90 and at 12 months.


Other Outcome Measures:
  1. Recanalization [ Time Frame: 24 hours ± 6 hours ]
    Recanalization at 24 hours ± 6 hours, by CT angiography.

  2. Volume of cerebral infarction [ Time Frame: 24 hours ± 6 hours ]
    Volume of cerebral infarction on NCCT and CTA source images.

  3. SICH [ Time Frame: 24 hours ± 6 hours. ]
    Symptomatic intracranial hemorrhage at 24 hours CT imaging ± 6 hours.

  4. Mortality [ Time Frame: 90 days ]
    Mortality at 90 days.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01717755


Contacts
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Contact: Wouter Schonewille, MD +31 6 41285149 w.schonewille@antoniusziekenhuis.nl
Contact: Erik van der Hoeven, MD +31 6 47490060 e.van.der.hoeven@antoniusziekenhuis.nl

Locations
Show Show 27 study locations
Sponsors and Collaborators
Erik van der Hoeven
BASICS Study Group
Investigators
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Principal Investigator: W J Schonewille, MD ST. Antonius hospital Nieuwegein
Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Erik van der Hoeven, E.J.R.J. van der Hoeven, MD, St. Antonius Hospital
ClinicalTrials.gov Identifier: NCT01717755    
Other Study ID Numbers: NL33550.100.10
NHS2010B151 ( Other Grant/Funding Number: Dutch Heart Foundation )
2010-023507-95 ( EudraCT Number )
First Posted: October 30, 2012    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018
Keywords provided by Erik van der Hoeven, St. Antonius Hospital:
basilar
stroke
mechanical
thrombolysis
intra-arterial
trombectomy
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Thrombosis
Embolism
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Embolism and Thrombosis