Basilar Artery International Cooperation Study Trial.
Recruiting
- Conditions
- Acute ischaemic stroke. CVA.Posterior circulation. Achterste hersencirculatie.Basilar artery occlusion. Arteria basilaris occlusie.
- Registration Number
- NL-OMON27663
- Lead Sponsor
- BASICS Study Group
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 750
Inclusion Criteria
1. Symptoms and signs compatible with ischemia in the basilar artery territory and an NIHSS ≥ 10 at time of randomization;
2. Basilar artery occlusion confirmed by CTA or MRA;
Exclusion Criteria
1. Pre-existing dependency with mRankin ≥3;
2. Females of childbearing potential who are known to be pregnant and/or lactating or
who have positive pregnancy tests on admission;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Favourable outcome at day 90 defined as a modified Rankin Score (mRS – functional scale) of 0-3.
- Secondary Outcome Measures
Name Time Method 1. Excellent outcome at day 90 defined as a modified Rankin Score (mRS – functional scale) of 0-2;<br /><br>2. Modified Rankin Score – not dichotomized;<br /><br>3. National Institutes of Health Stroke Scale (NIHSS – acute assessment scale) at time of IVT, at time randomization, at 48 hours post treatment;<br /><br>4. EQ-5D (quality of life) at day 90 and at 12 months.<br><br /><br /><br>Radiologic outcomes:<br /><br>1. Recanalization at 24 hours, ± 6 hours, by CT angiography;<br /><br>2. Volume of cerebral infarction on NCCT and CTA source images.<br><br /><br /><br>Safety outcomes:<br /><br>1. Symptomatic intracranial hemorrhage at 24 hours CT imaging, ± 6 hours;<br /><br>2. Mortality at 90 days.