Basilar Artery International Cooperation Study (BASICS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by St. Antonius Hospital
Sponsor:
Collaborator:
BASICS Study Group
Information provided by (Responsible Party):
Erik van der Hoeven, St. Antonius Hospital
ClinicalTrials.gov Identifier:
NCT01717755
First received: October 23, 2012
Last updated: October 26, 2012
Last verified: October 2012
  Purpose

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 treatment (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 additional IAT after IVT in patients with basilar artery occlusion.

Study design: Randomised, multi-centre, open label, controlled phase III, treatment trial

Study population: Patients, aged 18 through 85 years, with CTA or MRA confirmed basilar occlusion treated with IVT.

Target number of participants: 750.

Intervention: Patients will be randomised between additional IAT followed by maximum supportive care versus maximum supportive care alone. IVT has to be initiated within 4.5 hours from estimated time of basilar artery occlusion and IAT within 6 hours.

Main study parameters/endpoints: Favourable 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
Stroke
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

Resource links provided by NLM:


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: No additional intra-arterial treatment.
Intravenous thrombolysis followed by maximum supportive care.
Experimental: Additional intra-arterial treatment.
Intravenous thrombolysis followed by intra-arterial treatment and maximum supportive care.
Other: Intra-arterial treatment
The choice of the IA strategy will be made by the treating neurointerventionalist. IA treatment options available will be any of the following devices or thrombolytics, depending on local approval and experience; the Merci and Trevo thrombus-removal devices, Penumbra, Solitaire, infusion of rt-PA combined with an application of low-intensity ultrasound at the site of the occlusion via the EKOS Micro-Infusion Catheter, infusion of alteplase or urokinase via a standard micro-catheter. 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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptoms and signs compatible with ischemia in the basilar artery territory and an NIHSS ≥ 10 at time of randomization.
  • Basilar artery occlusion confirmed by CTA or MRA.
  • Age18 through 85 years (i.e., candidates must have had their 18th birthday, but not had their 86th birthday).
  • Initiation of IV rt-PA within 4.5 hours of estimated time of basilar artery occlusion. (Estimated time of basilar artery occlusion is defined as time of onset of acute symptoms leading to clinical diagnosis of basilar artery occlusion or if not known last time patient was seen normal prior to onset of these symptoms).
  • Initiation of IA therapy should be feasible within 6 hours of estimated time of basilar artery occlusion.

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 IA 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.
  • 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 ClinicalTrials.gov identifier: NCT01717755

Contacts
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
Italy
University Hospital Modena Recruiting
Modena, Italy, 41100
Principal Investigator: Andrea Zini, PhD         
Netherlands
Rijnstate Recruiting
Arnhem, Gelderland, Netherlands, 6800 TA
Principal Investigator: Jeanette Hofmeijer, PhD         
Academic Hospital Maastricht Recruiting
Maastricht, Limburg, Netherlands, 6229 HX
Principal Investigator: Julie Staals, PhD         
St. Elisabeth Hospital Recruiting
Tilburg, Noord Brabant, Netherlands, 5022 GC
Principal Investigator: Paul de Kort, PhD         
St. Antonius Hospital Recruiting
Nieuwegein, Utrecht, Netherlands, 3430 EM
Principal Investigator: Wouter Schonewille, MD         
MCH Westeinde Recruiting
The Hague, Zuid-Holland, Netherlands, 2512 VA
Principal Investigator: Jelis Boiten, PhD         
Universitary Medical Center Utrecht Recruiting
Utrecht, Netherlands, 3584 CX
Principal Investigator: Jaap Kappelle, Prof.         
Switzerland
University Hospital of Lausanne Recruiting
Lausanne, Vaud, Switzerland, CH-1011
Principal Investigator: Patrik Michel, PhD         
Sponsors and Collaborators
Erik van der Hoeven
BASICS Study Group
Investigators
Principal Investigator: W J Schonewille, MD St. Antonius Hospital Nieuwegein
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Erik van der Hoeven, E.J.R.J. van der Hoeven, MD, St. Antonius Hospital
ClinicalTrials.gov Identifier: NCT01717755     History of Changes
Other Study ID Numbers: NL33550.100.10, NHS2010B151, 2010-023507-95
Study First Received: October 23, 2012
Last Updated: October 26, 2012
Health Authority: Switzerland: Swissmedic
Italy: The Italian Medicines Agency

Keywords provided by St. Antonius Hospital:
basilar
stroke
mechanical
thrombolysis
intra-arterial

Additional relevant MeSH terms:
Cerebrovascular Disorders
Embolism
Stroke
Cerebral Infarction
Thrombosis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Embolism and Thrombosis
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 26, 2014