Acute Ischaemic StrokeFUN-TPANCT02164357
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
An observational study of Acute Ischaemic Stroke, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 5 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischaemic Stroke
- What is being tested?
- EVT (endovascular treatment ) and IVT (intravenous thrombolytic therapy)
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 124 participants
- Where
- 5 sitesSpain
- Study dates
- Sep 2012to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites
Hospital Gregorio Marañón
Madrid, Madrid, 28007
Hospital Universitario Ramón y Cajal
Madrid, Madrid, 28034
Hospital Clínico San Carlos
Madrid, Madrid, 28040
Hospital Universitario Doce de Octubre
Madrid, Madrid, 28041
Hospital Universitario La Paz
Madrid, Madrid, 28046
About this study
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
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.
- Conditions
- Acute Ischaemic Stroke
- Being tested
- EVT (endovascular treatment ), IVT (intravenous thrombolytic therapy)
- Keywords
- Ischaemic Stroke, Main artery occlusion, Endovascular treatment, Intravenous Thrombolytic Therapy
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVT (endovascular treatment )Procedure or surgery
IVT (intravenous thrombolytic therapy)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| EVT | Patients receiving endovascular treatment (EVT) within 4.5 hours after onset because intravenous thrombolytic therapy (IVT) is contraindicated Receives: Procedure: EVT (endovascular treatment ) | |
| IVT + EVT | Patients receiving intravenous thrombolytic therapy (IVT) followed by endovascular treatment (EVT) within 4.5 hours after onset Receives: 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 Receives: Procedure: IVT (intravenous thrombolytic therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death within 90 days after onset
Measured: 90 days
Symptomatic intracranial haemorrhage
Measured: 7 days
Secondary outcomes (2)
Stroke recovery rate after discharge
Recovery defined as a 10-fold decrease in NIHSS or NIHSS (7 days after onset or at discharge)
Measured: From onset to discharge
Functional recovery
Modified Rankin Score (RMS) value
Measured: 4.5 hours after onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2014 (estimated)
- Study startSep 2012
- Primary completionMay 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Ischaemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02164357
- Sponsor's protocol ID
- FUN-TPA-2012-01
- Acronym
- FUN-TPA
- Status last verified
- Jun 2015
- First submitted
- 12 Jun 2014
- Last updated
- 18 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27821473Kawiorski 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.
PubMed 26838587
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02164357
- Acronym / sponsor ID
- FUN-TPA / FUN-TPA-2012-01
- Conditions
- Acute Ischaemic Stroke
- Keywords
- Ischaemic Stroke, Main artery occlusion, Endovascular treatment, Intravenous Thrombolytic Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- May 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 16 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EVT | – | Procedure: EVT (endovascular treatment )Patients receiving endovascular treatment (EVT) within 4.5 hours after onset because intravenous thrombolytic therapy (IVT) is contraindicated |
| IVT + EVT | – | Procedure: EVT (endovascular treatment ), Procedure: IVT (intravenous thrombolytic therapy)Patients receiving intravenous thrombolytic therapy (IVT) followed by endovascular treatment (EVT) within 4.5 hours after onset |
| IVT (intravenous thrombolytic therapy) | – | Procedure: IVT (intravenous thrombolytic therapy)Patients that will received IVT only within 4.5 hours after onset |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EVT (endovascular treatment ) | Procedure or surgery | EVT, IVT + EVT |
| IVT (intravenous thrombolytic therapy) | Procedure or surgery | IVT (intravenous thrombolytic therapy), IVT + EVT |
Primary outcome
Death within 90 days after onset
Time frame: 90 days
Symptomatic intracranial haemorrhage
Time frame: 7 days
2 secondary outcomes
Stroke recovery rate after discharge
Time frame: From onset to discharge
Functional recovery
Time frame: 4.5 hours after onset
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2015.
- Derived from this study: PubMed 27821473Alonso 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.
- Derived from this study: PubMed 26838587Kawiorski 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischaemic Stroke, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 5 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death within 90 days after onset (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02164357, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2015.