International basilar artery trial

• Conditions: Basilar artery occlusion.; MedDRA version: 18.0Level: PTClassification code 10048963Term: Basilar artery occlusionSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]; MedDRA version: 18.0Level: PTClassification code 10063093Term: Basilar artery thrombosisSystem Organ Class: 10029205 - Nervous system disorders

• Registration Number: EUCTR2010-023507-95-NL
• Lead Sponsor: BASICS Study Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-16
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

• Symptoms and signs compatiblewith ischemia in the basilar artery territory
• Basilar artery occlusion confirmed by CTA or MRA
• Age18 or older (i.e., candidates must have had their 18th birthday).
• If IVT is considered as part of best medical treatment IV rt-PA needs to be initiated 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 – this time is not necessarily the same as the time of onset of first symptoms).
• Initiation of IA therapy should be feasible within 6 hours of estimated time of basilar artery occlusion.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 375
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 375

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 that 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 can not be obtained.

Imaging Exclusion Criteria:
•Lesion consistent with hemorrhage of any degree.
•Significant cerebellar mass effect or acute hydrocephalus
•Bilateral extended brainstem ischemia.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified