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Clinical Trials/NCT02164357
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

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.

Registry
clinicaltrials.gov
Start Date
September 2012
End Date
December 2015
Last Updated
10 years ago
Study Type
Observational
Sex
All

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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