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

Completed

• Conditions: Acute Ischaemic Stroke
• Interventions: Procedure: IVT (intravenous thrombolytic therapy); Procedure: EVT (endovascular treatment )

• Registration Number: NCT02164357
• Lead Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2014-06-12
• Study First Submitted QC: 2014-06-12
• Study First Posted: 2014-06-16
• Primary Completion: 2015-05
• Status Verified: 2015-06
• Study Completion: 2015-12
• Last Update Submitted: 2015-12-17
• Last Update Posted: 2015-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IVT (intravenous thrombolytic therapy)	IVT (intravenous thrombolytic therapy)	Patients that will received IVT only within 4.5 hours after onset
EVT	EVT (endovascular treatment )	Patients receiving endovascular treatment (EVT) within 4.5 hours after onset because intravenous thrombolytic therapy (IVT) is contraindicated
IVT + EVT	EVT (endovascular treatment )	Patients receiving intravenous thrombolytic therapy (IVT) followed by endovascular treatment (EVT) within 4.5 hours after onset
IVT + EVT	IVT (intravenous thrombolytic therapy)	Patients receiving intravenous thrombolytic therapy (IVT) followed by endovascular treatment (EVT) within 4.5 hours after onset

Primary Outcome Measures

Name	Time	Method
Death within 90 days after onset	90 days
Symptomatic intracranial haemorrhage	7 days

Secondary Outcome Measures

Name	Time	Method
Stroke recovery rate after discharge	From onset to discharge	Recovery defined as a 10-fold decrease in NIHSS or NIHSS (7 days after onset or at discharge)
Functional recovery	4.5 hours after onset	Modified Rankin Score (RMS) value

Trial Locations

Locations (5)

Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain

Hospital Gregorio Marañón; 🇪🇸 Madrid, Spain

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

Hospital Universitario Doce de Octubre; 🇪🇸 Madrid, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain