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 (FUN-TPA)

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Status: Completed

Conditions: Acute Ischaemic Stroke

Treatments: Procedure: EVT (endovascular treatment ); Procedure: IVT (intravenous thrombolytic therapy)

Study type: Observational

Funder types: Other

Identifiers

NCT02164357

FUN-TPA-2012-01

Details and patient eligibility

About

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.

Enrollment: 124 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

124 participants in 3 patient groups

EVT

Description:

Patients receiving endovascular treatment (EVT) within 4.5 hours after onset because intravenous thrombolytic therapy (IVT) is contraindicated

Treatment:

Procedure: EVT (endovascular treatment )

IVT + EVT

Description:

Patients receiving intravenous thrombolytic therapy (IVT) followed by endovascular treatment (EVT) within 4.5 hours after onset

Treatment:

Procedure: IVT (intravenous thrombolytic therapy)

Procedure: EVT (endovascular treatment )

IVT (intravenous thrombolytic therapy)

Description:

Patients that will received IVT only within 4.5 hours after onset

Treatment:

Procedure: IVT (intravenous thrombolytic therapy)