NCT02164357

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2012

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 16, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 18, 2015

Status Verified

June 1, 2015

Enrollment Period

2.7 years

First QC Date

June 12, 2014

Last Update Submit

December 17, 2015

Conditions

Acute Ischaemic Stroke

Keywords

Ischaemic StrokeMain artery occlusionEndovascular treatmentIntravenous Thrombolytic Therapy

Outcome Measures

Primary Outcomes (2)

  • Death within 90 days after onset

    90 days

  • Symptomatic intracranial haemorrhage

    7 days

Secondary Outcomes (2)

  • Stroke recovery rate after discharge

    From onset to discharge

  • Functional recovery

    4.5 hours after onset

Study Arms (3)

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)

Interventions

EVT (endovascular treatment )PROCEDURE
EVTIVT + EVT
IVT (intravenous thrombolytic therapy)PROCEDURE
IVT (intravenous thrombolytic therapy)IVT + EVT

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hospital Gregorio Marañón

Madrid, Madrid, 28007, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Madrid, 28034, Spain

Location

Hospital Clínico San Carlos

Madrid, Madrid, 28040, Spain

Location

Hospital Universitario Doce de Octubre

Madrid, Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

Location

Related Publications (2)

  • Alonso de Lecinana M, Martinez-Sanchez P, Garcia-Pastor A, Kawiorski MM, Calleja P, Sanz-Cuesta BE, Diaz-Otero F, Frutos R, Sierra-Hidalgo F, Ruiz-Ares G, Fandino E, Diez-Tejedor E, Gil-Nunez A, Fuentes B. Mechanical thrombectomy in patients with medical contraindications for intravenous thrombolysis: a prospective observational study. J Neurointerv Surg. 2017 Nov;9(11):1041-1046. doi: 10.1136/neurintsurg-2016-012727. Epub 2016 Nov 7.

    PMID: 27821473DERIVED

  • Kawiorski MM, Martinez-Sanchez P, Garcia-Pastor A, Calleja P, Fuentes B, Sanz-Cuesta BE, Lourido D, Marin B, Diaz-Otero F, Vicente A, Sierra-Hidalgo F, Ruiz-Ares G, Diez-Tejedor E, Fandino E, Alonso de Lecinana M. Alberta Stroke Program Early CT Score applied to CT angiography source images is a strong predictor of futile recanalization in acute ischemic stroke. Neuroradiology. 2016 May;58(5):487-93. doi: 10.1007/s00234-016-1652-7. Epub 2016 Feb 2.

    PMID: 26838587DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2014

First Posted

June 16, 2014

Study Start

September 1, 2012

Primary Completion

May 1, 2015

Study Completion

December 1, 2015

Last Updated

December 18, 2015

Record last verified: 2015-06

Locations

ES(5)