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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)

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ClinicalTrials.gov Identifier: NCT02164357
Recruitment Status : Completed
First Posted : June 16, 2014
Last Update Posted : December 18, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Acute Ischaemic Stroke Procedure: EVT (endovascular treatment ) Procedure: IVT (intravenous thrombolytic therapy)

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Study Type : Observational
Actual Enrollment : 124 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : September 2012
Actual Primary Completion Date : May 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke

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)



Primary Outcome Measures :
  1. Death within 90 days after onset [ Time Frame: 90 days ]
  2. Symptomatic intracranial haemorrhage [ Time Frame: 7 days ]

Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02164357


Locations
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Spain
Hospital Gregorio Marañón
Madrid, Spain, 28007
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Hospital Clínico San Carlos
Madrid, Spain, 28040
Hospital Universitario Doce de Octubre
Madrid, Spain, 28041
Hospital Universitario La Paz
Madrid, Spain, 28046
Sponsors and Collaborators
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier: NCT02164357    
Other Study ID Numbers: FUN-TPA-2012-01
First Posted: June 16, 2014    Key Record Dates
Last Update Posted: December 18, 2015
Last Verified: June 2015
Keywords provided by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal:
Ischaemic Stroke
Main artery occlusion
Endovascular treatment
Intravenous Thrombolytic Therapy
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Infarction
Necrosis
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action