NCT01717755

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
282

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable

Geographic Reach
6 countries

27 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 30, 2012

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

January 18, 2018

Status Verified

January 1, 2018

Enrollment Period

7.3 years

First QC Date

October 23, 2012

Last Update Submit

January 16, 2018

Conditions

Basilar Artery ThrombosisBasilar Artery EmbolismStroke of Basilar ArteryStrokeCerebrovascular DisordersBasilar Artery Occlusion

Keywords

basilarstrokemechanicalthrombolysisintra-arterialtrombectomy

Outcome Measures

Primary Outcomes (1)

  • Favourable outcome

    Favourable outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-3.

    day 90

Secondary Outcomes (4)

  • Excellent outcome

    day 90

  • Modified Rankin Score

    day 90

  • NIHSS

    pre IVT, pre randomization, 24h post treatment

  • EQ-5D

    day 90 and 12 months

Other Outcomes (4)

  • Recanalization

    24 hours ± 6 hours

  • Volume of cerebral infarction

    24 hours ± 6 hours

  • SICH

    24 hours ± 6 hours.

  • +1 more other outcomes

Study Arms (2)

Best medical management.

NO INTERVENTION

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.

Additional intra-arterial treatment.

EXPERIMENTAL

Best medical management followed by intra-arterial treatment and best medical management

Other: Intra-arterial treatment

Interventions

Intra-arterial treatmentOTHER

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.

Additional intra-arterial treatment.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • High-density lesion consistent with hemorrhage of any degree.
  • Significant cerebellar mass effect or acute hydrocephalus.
  • Bilateral extended brainstem ischemia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Fortaleza General Hospital

Fortaleza, Brazil

RECRUITING

Hospital das Clinicas de Ribeirao Preto

Ribeirão Preto, Brazil

RECRUITING

Klinikum Augsburg

Augsburg, Germany

RECRUITING

Berlin Charite Hospital

Berlin, Germany

RECRUITING

Dresden University Hospital

Dresden, Germany

RECRUITING

University Medical Center Mannheim

Mannheim, Germany

TERMINATED

Oberschwabenklinik

Ravensburg, Germany

TERMINATED

Bergamo Hospital

Bergamo, Italy

RECRUITING

Genova Hospital

Genoa, Italy

RECRUITING

University Hospital Modena

Modena, 41100, Italy

RECRUITING

Santa Corona Hospital

Pietra Ligure, Italy

RECRUITING

Roma Umberto I

Rome, Italy

WITHDRAWN

Varese Hospital

Varese, Italy

RECRUITING

Rijnstate

Arnhem, Gelderland, 6800 TA, Netherlands

SUSPENDED

Academic Hospital Maastricht

Maastricht, Limburg, 6229 HX, Netherlands

RECRUITING

St. Elisabeth Hospital

Tilburg, North Brabant, 5022 GC, Netherlands

RECRUITING

Academic Medical Center

Amsterdam, North Holland, 1105AZ, Netherlands

RECRUITING

MCH Westeinde

The Hague, South Holland, 2512 VA, Netherlands

RECRUITING

St. Antonius Hospital

Nieuwegein, Utrecht, 3430 EM, Netherlands

RECRUITING

University Medical Center Groningen

Groningen, Netherlands

WITHDRAWN

Leiden University Hospital

Leiden, Netherlands

RECRUITING

Erasmus Medical Center

Rotterdam, Netherlands

RECRUITING

Haga Hospital

The Hague, Netherlands

RECRUITING

Universitary Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

RECRUITING

University Hospital North Norway

Tromsø, Norway

RECRUITING

St. Olavs Hospital Trondheim

Trondheim, Norway

RECRUITING

University Hospital of Lausanne

Lausanne, Canton of Vaud, CH-1011, Switzerland

RECRUITING

Related Publications (11)

  • 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.

    PMID: 19577962BACKGROUND

  • 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.

    PMID: 22442438BACKGROUND

  • 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.

    PMID: 22527236BACKGROUND

  • 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.

    PMID: 21960577BACKGROUND

  • 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.

    PMID: 20947845BACKGROUND

  • 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.

    PMID: 18705948BACKGROUND

  • 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. doi: 10.1161/01.STR.0000237127.84408.c0. Epub 2006 Aug 10. No abstract available.

    PMID: 16902170BACKGROUND

  • 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.

    PMID: 22989501BACKGROUND

  • Roaldsen MB, Jusufovic M, Berge E, Lindekleiv H. Endovascular thrombectomy and intra-arterial interventions for acute ischaemic stroke. Cochrane Database Syst Rev. 2021 Jun 14;6(6):CD007574. doi: 10.1002/14651858.CD007574.pub3.

    PMID: 34125952DERIVED

  • Langezaal LCM, van der Hoeven EJRJ, Mont'Alverne FJA, de Carvalho JJF, Lima FO, Dippel DWJ, van der Lugt A, Lo RTH, Boiten J, Lycklama A Nijeholt GJ, Staals J, van Zwam WH, Nederkoorn PJ, Majoie CBLM, Gerber JC, Mazighi M, Piotin M, Zini A, Vallone S, Hofmeijer J, Martins SO, Nolte CH, Szabo K, Dias FA, Abud DG, Wermer MJH, Remmers MJM, Schneider H, Rueckert CM, de Laat KF, Yoo AJ, van Doormaal PJ, van Es ACGM, Emmer BJ, Michel P, Puetz V, Audebert HJ, Pontes-Neto OM, Vos JA, Kappelle LJ, Algra A, Schonewille WJ; BASICS Study Group. Endovascular Therapy for Stroke Due to Basilar-Artery Occlusion. N Engl J Med. 2021 May 20;384(20):1910-1920. doi: 10.1056/NEJMoa2030297.

    PMID: 34010530DERIVED

  • van der Hoeven EJ, Schonewille WJ, Vos JA, Algra A, Audebert HJ, Berge E, Ciccone A, Mazighi M, Michel P, Muir KW, Obach V, Puetz V, Wijman CA, Zini A, Kappelle JL; BASICS Study Group. The Basilar Artery International Cooperation Study (BASICS): study protocol for a randomised controlled trial. Trials. 2013 Jul 8;14:200. doi: 10.1186/1745-6215-14-200.

    PMID: 23835026DERIVED

MeSH Terms

Conditions

StrokeCerebrovascular Disorders

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • W J Schonewille, MD

    St. Antonius Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wouter Schonewille, MD

CONTACT

+31 6 41285149w.schonewille@antoniusziekenhuis.nl

Erik van der Hoeven, MD

CONTACT

+31 6 47490060e.van.der.hoeven@antoniusziekenhuis.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
E.J.R.J. van der Hoeven, MD

Study Record Dates

First Submitted

October 23, 2012

First Posted

October 30, 2012

Study Start

October 1, 2011

Primary Completion

January 1, 2019

Study Completion

January 1, 2020

Last Updated

January 18, 2018

Record last verified: 2018-01

Locations

NO(2)DE(5)CH(1)BR(2)NL(11)IT(6)