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OpenTrials
Completed

NCT Number: 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

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.

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Key information

Conditions

Acute Ischaemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Clínico San Carlos, Madrid, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EVT (endovascular treatment )

Procedure

IVT (intravenous thrombolytic therapy)

Procedure

Primary outcomes

  1. Death within 90 days after onset

    Time frame: 90 days

  2. Symptomatic intracranial haemorrhage

    Time frame: 7 days

Secondary outcomes

  1. 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)

  2. Functional recovery

    Time frame: 4.5 hours after onset

    Modified Rankin Score (RMS) value

Sponsors and collaborators

Lead sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Other

Registry information

Official study 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

Acronym: FUN-TPA

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jun 16, 2014
Registry last updated
Dec 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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