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)

December 17, 2015 updated by: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

124

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28034
        • Hospital Universitario Ramón y Cajal
      • Madrid, Spain, 28040
        • Hospital Clínico San Carlos
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28007
        • Hospital Gregorio Marañón
      • Madrid, Spain, 28041
        • Hospital Universitario Doce de Octubre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Death within 90 days after onset
Time Frame: 90 days
90 days
Symptomatic intracranial haemorrhage
Time Frame: 7 days
7 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

June 12, 2014

First Submitted That Met QC Criteria

June 12, 2014

First Posted (Estimate)

June 16, 2014

Study Record Updates

Last Update Posted (Estimate)

December 18, 2015

Last Update Submitted That Met QC Criteria

December 17, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUN-TPA-2012-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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