Basilar Artery International Cooperation Study

Not Applicable

• Conditions: Basilar Artery Embolism; Basilar Artery Occlusion; Basilar Artery Thrombosis; Stroke; Stroke of Basilar Artery; Cerebrovascular Disorders
• Interventions: Other: Intra-arterial treatment

• Registration Number: NCT01717755
• Lead Sponsor: Erik van der Hoeven

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-10-23
• Study First Submitted QC: 2012-10-26
• Study First Posted: 2012-10-30
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-16
• Last Update Posted: 2018-01-18
• Primary Completion: 2019-01
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 282

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Additional intra-arterial treatment.	Intra-arterial treatment	Best medical management followed by intra-arterial treatment and best medical management

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
EQ-5D	day 90 and 12 months	EQ-5D (quality of life) at day 90 and at 12 months.
Excellent outcome	day 90	Excellent outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-2.
Modified Rankin Score	day 90	Modified Rankin Score - not dichotomized.
NIHSS	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.

Trial Locations

Locations (27)

University Hospital North Norway; 🇳🇴 Tromso, Norway

Academic Hospital Maastricht; 🇳🇱 Maastricht, Limburg, Netherlands

St. Olavs Hospital Trondheim; 🇳🇴 Trondheim, Norway

St. Antonius Hospital; 🇳🇱 Nieuwegein, Utrecht, Netherlands

Hospital das Clinicas de Ribeirao Preto; 🇧🇷 Ribeirão Preto, Brazil

University Medical Center Mannheim; 🇩🇪 Mannheim, Germany

University Hospital of Lausanne; 🇨🇭 Lausanne, Vaud, Switzerland

Academic Medical Center; 🇳🇱 Amsterdam, Noord-Holland, Netherlands

Berlin Charite Hospital; 🇩🇪 Berlin, Germany

Fortaleza General Hospital; 🇧🇷 Fortaleza, Brazil

Klinikum Augsburg; 🇩🇪 Augsburg, Germany

Dresden University Hospital; 🇩🇪 Dresden, Germany

Bergamo Hospital; 🇮🇹 Bergamo, Italy

Oberschwabenklinik; 🇩🇪 Ravensburg, Germany

Genova Hospital; 🇮🇹 Genua, Italy

Rijnstate; 🇳🇱 Arnhem, Gelderland, Netherlands

University Hospital Modena; 🇮🇹 Modena, Italy

Roma Umberto I; 🇮🇹 Rome, Italy

Varese Hospital; 🇮🇹 Varese, Italy

Santa Corona Hospital; 🇮🇹 Pietra Ligure, Italy

St. Elisabeth Hospital; 🇳🇱 Tilburg, Noord Brabant, Netherlands

Leiden University Hospital; 🇳🇱 Leiden, Netherlands

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands

Haga Hospital; 🇳🇱 The Hague, Netherlands

MCH Westeinde; 🇳🇱 The Hague, Zuid-Holland, Netherlands

Universitary Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands