Basilar Artery International Cooperation Study (BASICS)

Erik van der Hoeven

Status: Unknown

Conditions: Basilar Artery Occlusion; Stroke; Basilar Artery Embolism; Basilar Artery Thrombosis; Cerebrovascular Disorders; Stroke of Basilar Artery

Treatments: Other: Intra-arterial treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01717755

NHS2010B151 (Other Grant/Funding Number)

NL33550.100.10

2010-023507-95 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 282 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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282 participants in 2 patient groups

Best medical management.

No Intervention group

Description:

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 group

Description:

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

Treatment:

Other: Intra-arterial treatment