Clinical trial NCT02164357: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Ischaemic Stroke
Keywords: Ischaemic Stroke
Main artery occlusion
Endovascular treatment
Intravenous Thrombolytic Therapy
Lead sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
First posted: 2014-06-16
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients younger than 80 with acute ischemic stroke produced by a main artery oclussion with a NIHSS \> 6 (National Institute of Health Stroke Scale) receiving IVT or EVT within 4.5 hours after onset.

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.


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.

Primary outcomes:
measure: Death within 90 days after onset
timeFrame: 90 days
measure: Symptomatic intracranial haemorrhage
timeFrame: 7 days
Secondary outcomes:
measure: Stroke recovery rate after discharge
timeFrame: From onset to discharge
measure: Functional recovery
timeFrame: 4.5 hours after onset
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario Doce de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
References:
citation: Alonso de Lecinana M, Martinez-Sanchez P, Garcia-Pastor A, Kawiorski MM, Calleja P, Sanz-Cuesta BE, Diaz-Otero F, Frutos R, Sierra-Hidalgo F, Ruiz-Ares G, Fandino E, Diez-Tejedor E, Gil-Nunez A, Fuentes B. Mechanical thrombectomy in patients with medical contraindications for intravenous thrombolysis: a prospective observational study. J Neurointerv Surg. 2017 Nov;9(11):1041-1046. doi: 10.1136/neurintsurg-2016-012727. Epub 2016 Nov 7.
citation: Kawiorski MM, Martinez-Sanchez P, Garcia-Pastor A, Calleja P, Fuentes B, Sanz-Cuesta BE, Lourido D, Marin B, Diaz-Otero F, Vicente A, Sierra-Hidalgo F, Ruiz-Ares G, Diez-Tejedor E, Fandino E, Alonso de Lecinana M. Alberta Stroke Program Early CT Score applied to CT angiography source images is a strong predictor of futile recanalization in acute ischemic stroke. Neuroradiology. 2016 May;58(5):487-93. doi: 10.1007/s00234-016-1652-7. Epub 2016 Feb 2.