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Clinical Trials/EUCTR2010-023507-95-IT
EUCTR2010-023507-95-ITActive, not recruitingNot Applicable

BASICS Trial (Basilar Artery International Cooperation Study Research Protocol) - BASICS trial

St. Antonius Hospital0 sites750 target enrollmentStarted: October 11, 2012Last updated:
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Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
750
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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 - 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.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range: 0
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 300
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 450

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.

Investigators

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