NCT02164357
Completed
Not Applicable
Efficacy and Security of an Endovascular Treatment as First Choice Procedure Compared With a Standard Intravenous Thrombolytic Therapy Treatment for Patients With Acute Ischemic Stroke Within 4.5 Hours After Onset: A Prospective Cohorts Study
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal5 sites in 1 country124 target enrollmentSeptember 2012
ConditionsAcute Ischaemic Stroke
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Ischaemic Stroke
- Sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Enrollment
- 124
- Locations
- 5
- Primary Endpoint
- Death within 90 days after onset
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
This study will compare two ways of treatment for acute ischemic stroke: an endovascular treatment (EVT), defined as intraarterial thrombolysis and/or mechanical thrombectomy as a first choice treatment versus intravenous thrombolytic therapy (IVT) only or followed by EVT in patients with acute ischemic stroke due to a main brain artery occlusion within 4.5 hours after onset. Patients treated with IVT only or with IVT followed by EVT will be analyzed separately.
Investigators
Eligibility Criteria
Inclusion Criteria
- •80 or less years old patients with acute stroke produced by a main artery occlusion
- •NIHSS National Institutes of Health Stroke Scale score greater than 6 (severe neurological impairment)
- •Patients receiving EVT or IVT within 4.5 hours after onset
Exclusion Criteria
- •EVT or IVT contraindication
- •Previous neurological impairment, severe concomitant disease or poor prognosis.
- •Pregnancy or breastfeeding
- •Known hypersensitivity to any study drugs
- •Severe organic disease for which there is not risk compensation.
Outcomes
Primary Outcomes
Death within 90 days after onset
Time Frame: 90 days
Symptomatic intracranial haemorrhage
Time Frame: 7 days
Secondary Outcomes
- Stroke recovery rate after discharge(From onset to discharge)
- Functional recovery(4.5 hours after onset)
Study Sites (5)
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