Basilar Artery International Cooperation Study (BASICS)

January 16, 2018 updated by: Erik van der Hoeven

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

282

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
      • Fortaleza, Brazil
        • Recruiting
        • Fortaleza General Hospital
        • Contact:
          • F Mont Alverne
      • Ribeirão Preto, Brazil
        • Recruiting
        • Hospital das Clínicas de Ribeirão Preto
        • Contact:
          • O Pontes Neto
  • Germany
      • Augsburg, Germany
        • Recruiting
        • Klinikum Augsburg
        • Contact:
          • Hauke Schneider
      • Berlin, Germany
        • Recruiting
        • Berlin Charite Hospital
        • Principal Investigator:
          • Heinrich Audebert, MD, PhD
      • Dresden, Germany
        • Recruiting
        • Dresden University Hospital
        • Principal Investigator:
          • Volker Puetz, MD, PhD
      • Mannheim, Germany
        • Terminated
        • University Medical Center Mannheim
      • Ravensburg, Germany
        • Terminated
        • Oberschwabenklinik
  • Italy
      • Bergamo, Italy
        • Recruiting
        • Bergamo Hospital
        • Principal Investigator:
          • Bruno Censori, MD, PhD
      • Genua, Italy
        • Recruiting
        • Genova Hospital
        • Principal Investigator:
          • Laura Malfatto, MD, PhD
      • Modena, Italy, 41100
        • Recruiting
        • University Hospital Modena
        • Principal Investigator:
          • Andrea Zini, MD, PhD
      • Pietra Ligure, Italy
        • Recruiting
        • Santa Corona Hospital
        • Contact:
          • T. Tassinari
      • Rome, Italy
        • Withdrawn
        • Roma Umberto I
      • Varese, Italy
        • Recruiting
        • Varese Hospital
        • Principal Investigator:
          • M.L. DeLodovici, MD, PhD
  • Netherlands
      • Groningen, Netherlands
        • Withdrawn
        • University Medical Center Groningen
      • Leiden, Netherlands
        • Recruiting
        • Leiden University Hospital
        • Principal Investigator:
          • Marieke Wermer, MD, PhD
      • Rotterdam, Netherlands
        • Recruiting
        • Erasmus Medical Center
        • Contact:
          • Diederik Dippel
      • The Hague, Netherlands
        • Recruiting
        • Haga Hospital
        • Principal Investigator:
          • Karlijn de Laat, MD, PhD
      • Utrecht, Netherlands, 3584 CX
        • Recruiting
        • Universitary Medical Center Utrecht
        • Principal Investigator:
          • Jaap Kappelle, MD, PhD
    • Gelderland
      • Arnhem, Gelderland, Netherlands, 6800 TA
        • Suspended
        • Rijnstate
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229 HX
        • Recruiting
        • Academic Hospital Maastricht
        • Principal Investigator:
          • Julie Staals, MD, PhD
    • Noord Brabant
      • Tilburg, Noord Brabant, Netherlands, 5022 GC
        • Recruiting
        • St. Elisabeth Hospital
        • Principal Investigator:
          • Paul de Kort, MD, PhD
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1105AZ
        • Recruiting
        • Academic Medical Center
        • Principal Investigator:
          • Paul Nederkoorn, MD, PhD
    • Utrecht
      • Nieuwegein, Utrecht, Netherlands, 3430 EM
        • Recruiting
        • St. Antonius Hospital
        • Principal Investigator:
          • Wouter Schonewille, MD, PhD
    • Zuid-Holland
      • The Hague, Zuid-Holland, Netherlands, 2512 VA
        • Recruiting
        • MCH Westeinde
        • Principal Investigator:
          • Jelis Boiten, MD, PhD
  • Norway
      • Tromso, Norway
        • Recruiting
        • University Hospital North Norway
        • Principal Investigator:
          • Stein Harald Johnsen
      • Trondheim, Norway
        • Recruiting
        • St. Olavs Hospital Trondheim
        • Principal Investigator:
          • Gitta Rohweder, MD, PhD
  • Switzerland
    • Vaud
      • Lausanne, Vaud, Switzerland, CH-1011
        • Recruiting
        • University Hospital of Lausanne
        • Principal Investigator:
          • Patrik Michel, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Favourable outcome
Time Frame: day 90
Favourable outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-3.
day 90

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Excellent outcome
Time Frame: day 90
Excellent outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-2.
day 90
Modified Rankin Score
Time Frame: day 90
Modified Rankin Score - not dichotomized.
day 90
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.
pre IVT, pre randomization, 24h post treatment
EQ-5D
Time Frame: day 90 and 12 months
EQ-5D (quality of life) at day 90 and at 12 months.
day 90 and 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recanalization
Time Frame: 24 hours ± 6 hours
Recanalization at 24 hours ± 6 hours, by CT angiography.
24 hours ± 6 hours
Volume of cerebral infarction
Time Frame: 24 hours ± 6 hours
Volume of cerebral infarction on NCCT and CTA source images.
24 hours ± 6 hours
SICH
Time Frame: 24 hours ± 6 hours.
Symptomatic intracranial hemorrhage at 24 hours CT imaging ± 6 hours.
24 hours ± 6 hours.
Mortality
Time Frame: 90 days
Mortality at 90 days.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erik van der Hoeven

Collaborators

BASICS Study Group

Investigators

  • Principal Investigator: W J Schonewille, MD, St. Antonius Hospital Nieuwegein

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

October 23, 2012

First Submitted That Met QC Criteria

October 26, 2012

First Posted (Estimate)

October 30, 2012

Study Record Updates

Last Update Posted (Actual)

January 18, 2018

Last Update Submitted That Met QC Criteria

January 16, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL33550.100.10
  • NHS2010B151 (Other Grant/Funding Number: Dutch Heart Foundation)
  • 2010-023507-95 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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