Ischemic StrokeEBRICTUSNCT03247036
Long-Term Survival After Ischaemic Stroke: Ebrictus Study
An observational study of Ischemic Stroke and Thrombolytic (t-PA) Treatment, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
A number of large trials have confirmed the benefits of thrombolysis in acute stroke, but there are gender differences. The authors sought to examine the relationship between sex and outcome after thrombolysis. Read more about this study
- Who is it for?
- Ages 15 to 90 years
- Conditions the study is for
- Ischemic Stroke, Thrombolytic (t-PA) Treatment, Gender Bias
- What is being tested?
- IV thrombolytic (t-PA) treatment vs not
- Type of treatment
- Injection or infusion
- How many people
- 21,000 participants
- Where
- 1 siteSpain
- Study dates
- 13 Jan 2017to 5 Aug 2017
- How long will I take part?
- 5 Years
- 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 15 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients were included by using the automated operation of the database of patients with a diagnosis code of stroke (I60-I69).
Who may be able to join
- age ≥ 15 up to ≤ 90;
- usual residence in Catalonia
- and/or assignment to any of the catalonian primary care centers for 5 years at the time of the stroke episode;
- a diagnosis of stroke explicitly recorded in their medical record at any of the registration systems in the health centers of the area; it should be a first stroke episode, and relevant episode information should be available in clinical records: (a) outpatient clinic, (b)hospital clinic, or (c) access to medical/sociosanitary reports.
Who cannot join
- intracerebral haemorrhage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long Survival After Ischemic Stroke and Thombolysis in Catalonia. Differences by Sex
A number of large trials have confirmed the benefits of thrombolysis in acute stroke, but there are gender differences. The authors sought to examine the relationship between sex and outcome after thrombolysis.
Previous reports [1-6] concerning sex-related differences in stroke management and outcome are inconsistent and sometimes difficult to interpret, and so the reasons for gender disparities in stroke outcome have remained unclear. Functional outcomes and quality of life after stroke are consistently poorer in women despite adjustment for baseline differences in age and prestroke function, and the fact that comorbidities and clinical outcomes were not different between women and men [3, 7] . Once the reasons for these differences are better understood, intervention might be possible to help provide the best care for all patients. This work is a continuation and extension of the Ebrictus Study [8-10] . Prior work has suggested sex-based differences in thrombolytic therapy in subjects with acute stroke [11] .The authors will explore whether sex might modify the effect of thrombolysis on survival and functional outcomes in patients with acute ischemic stroke [12] beyond the usually evaluated time period of 6 months after stroke and compared this with the group without thrombolytic treatment.
Read the detailed description
This is a reprospective, observational cohort study including incident strokes from January 1, 2011 to December 31, 2012 and followed up in December 31, 2016. Statistical approaches are used to analyze survival outcomes. It is a longitudinal study of a population-based cohort of all registered cases of a first episode of stroke that occurred in Catalonia (Spain). Demographic Patterns and Epidemic Characteristics. Life expectancy at birth is 81.34 years globally, 78.26 years for men and 84.74 years for women.
Case Definition The definition of stroke corresponds to that set by the World Health Organization.
Patients were included by using the automated operation of the database of patients with a diagnosis code of stroke (I60-I69).
The inclusion criteria were: age ≥ 15 up to ≤ 90; a diagnosis of stroke explicitly recorded in their medical record at any of the registration systems in the health centers; it should be a first stroke episode, and relevant episode information should be available in clinical records: (a) outpatient clinic, (b) hospital clinic, or (c) access to medical/sociosanitary reports.
The variables on which information was collected were grouped as follows: sociodemographic; clinics: type (ischemic or hemorrhagic stroke) and event date (day/month/year); NIHSS score on admission; whether or not there was thrombolytic therapy; duration of hospital stay; hospital discharge destination (home, higher-level acute hospital, long-term care hospital, death and date thereof); pre- and poststroke functional autonomy [the Barthel score was classified as follows: <20 (total dependence), 20-35 (severe dependence), 40-55 (moderate dependence), ≥ 60 (mild dependence), or 100 (independence) registered for preepisode and for discharge in the medical history of the patient, the hospital, or the primary care center]; functional status of the patient at discharge: death, home-autonomous, home address caregiver, referral to another acute hospital, or convalescent center (temporary or long-term stay), and vital status (alive/dead) of the patient, specifying the date (day/month/year) of death, if any.
Statistical Analysis Computerized statistical analysis was undertaken with the following: (1) descriptive basic statistics and standard deviation of key variables stratified by age and sex and (2) differences in functional outcome and its evolution before and after the episode determined the possible effects on mortality and different residual deficits categorized with the statistical Cox regression model. Mortality should be interpreted as overall mortality and cause-specific, no stroke. Patients who died during hospitalization or within the 1st month are considered 'immediate death'. During follow-up the deceased are described as 'subsequent mortality'.
- Being tested
- IV thrombolytic (t-PA) treatment vs not
- Medical subject headings
- Ischemic Stroke, Sexism, Long Term Adverse Effects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV thrombolytic (t-PA) treatment vs notDrug
Also called IV thrombolysis, IV thrombolytic (t-PA) treatment
Acute Stroke Protocol
What is being measured
The primary outcome is the main question the study is designed to answer.
Death all causes
Mortality should be interpreted as overall mortality and cause-specific, no stroke. Patients who died during hospitalization or within the 1st month are considered 'immediate death'. During follow-up the deceased are described as 'subsequent mortality'.
Measured: January 1, 2011 to December 31, 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start13 Jan 2017
- Primary completion30 Jul 2017
- Study completion5 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ischemic 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
- Cross-sectional
- Enrolment
- 21,000 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josep Lluís Clua Espuny, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03247036
- Sponsor's protocol ID
- 4R17/017
- Other IDs
- 17/034 Codi IDIAP: 4R17/017
- Acronym
- EBRICTUS
- Status last verified
- Apr 2022
- First submitted
- 8 Aug 2017
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Dates files
Publications
Clua-Espuny JL, Ripolles-Vicente R, Forcadell-Arenas T, Gil-Guillen VF, Queralt-Tomas ML, Gonzalez-Henares MA, Panisello-Tafalla A, Lopez-Pablo C, Lucas-Noll J; Ebrictus Group. Sex Differences in Long-Term Survival after a First Stroke with Intravenous Thrombolysis: Ebrictus Study. Cerebrovasc Dis Extra. 2015 Oct 9;5(3):95-102. doi: 10.1159/000440734. eCollection 2015 Sep-Dec.
PubMed 26648964Clua-Espuny JL, Ripolles-Vicente R, Lopez-Pablo C, Panisello-Tafalla A, Lucas-Noll J, Calduch-Noll C, Gonzalez-Henares MA, Queralt-Tomas ML. [Differences in the survival after an episode of stroke treated with thrombolytic therapy. Study Ebrictus]. Aten Primaria. 2015 Feb;47(2):108-16. doi: 10.1016/j.aprim.2014.04.008. Epub 2014 Jun 19. Spanish.
PubMed 24953174Gonzalez-Henares A, Clua-Espuny JL, Gil-Guillen VF, Panisello-Tafalla A, Queralt-Tomas ML, Ripolles-Vicente R, Lopez-Pablo C, Lucas-Noll J, Equipo de Investigacion Ebrictus Ede I. [Incidence and preventability of haemorrhagic strokes. Results of the Ebrictus register]. Rev Neurol. 2016 May 1;62(9):385-95. Spanish.
PubMed 27113062Clua-Espuny JL, Abilleira S, Queralt-Tomas L, Gonzalez-Henares A, Gil-Guillen V, Muria-Subirats E, Ballesta-Ors J. Long-Term Survival After Stroke According to Reperfusion Therapy, Cardiovascular Therapy and Gender. Cardiol Res. 2019 Apr;10(2):89-97. doi: 10.14740/cr839. Epub 2019 Apr 11.
PubMed 31019638Clua-Espuny JL, Pinol-Moreso JL, Gil-Guillen FV, Orozco-Beltran D, Panisello-Tafalla A, Lucas-Noll J. [The stroke care system in Terres de l'Ebre, Spain, after the implementation of the Stroke Code model: Ebrictus Study]. Med Clin (Barc). 2012 May 19;138(14):609-11. doi: 10.1016/j.medcli.2011.10.004. Epub 2011 Dec 6. Spanish.
PubMed 22153783
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Survival After Ischemic Stroke and Thombolysis in Catalonia. Differences by Sex
- ClinicalTrials.gov ID
- NCT03247036
- Acronym / sponsor ID
- EBRICTUS / 4R17/017
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21,000 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Study start
- 13 Jan 2017 (actual)
- Primary completion
- 30 Jul 2017 (actual)
- Study completion
- 5 Aug 2017 (actual)
- First posted
- 11 Aug 2017 (actual)
- 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.
A number of large trials have confirmed the benefits of thrombolysis in acute stroke, but there are gender differences. The authors sought to examine the relationship between sex and outcome after thrombolysis.
Previous reports [1-6] concerning sex-related differences in stroke management and outcome are inconsistent and sometimes difficult to interpret, and so the reasons for gender disparities in stroke outcome have remained unclear. Functional outcomes and quality of life after stroke are consistently poorer in women despite adjustment for baseline differences in age and prestroke function, and the fact that comorbidities and clinical outcomes were not different between women and men [3, 7] . Once the reasons for these differences are better understood, intervention might be possible to help provide the best care for all patients. This work is a continuation and extension of the Ebrictus Study [8-10] . Prior work has suggested sex-based differences in thrombolytic therapy in subjects with acute stroke [11] .The authors will explore whether sex might modify the effect of thrombolysis on survival and functional outcomes in patients with acute ischemic stroke [12] beyond the usually evaluated time period of 6 months after stroke and compared this with the group without thrombolytic treatment.
Detailed description
This is a reprospective, observational cohort study including incident strokes from January 1, 2011 to December 31, 2012 and followed up in December 31, 2016. Statistical approaches are used to analyze survival outcomes. It is a longitudinal study of a population-based cohort of all registered cases of a first episode of stroke that occurred in Catalonia (Spain). Demographic Patterns and Epidemic Characteristics. Life expectancy at birth is 81.34 years globally, 78.26 years for men and 84.74 years for women.
Case Definition The definition of stroke corresponds to that set by the World Health Organization.
Patients were included by using the automated operation of the database of patients with a diagnosis code of stroke (I60-I69).
The inclusion criteria were: age ≥ 15 up to ≤ 90; a diagnosis of stroke explicitly recorded in their medical record at any of the registration systems in the health centers; it should be a first stroke episode, and relevant episode information should be available in clinical records: (a) outpatient clinic, (b) hospital clinic, or (c) access to medical/sociosanitary reports.
The variables on which information was collected were grouped as follows: sociodemographic; clinics: type (ischemic or hemorrhagic stroke) and event date (day/month/year); NIHSS score on admission; whether or not there was thrombolytic therapy; duration of hospital stay; hospital discharge destination (home, higher-level acute hospital, long-term care hospital, death and date thereof); pre- and poststroke functional autonomy [the Barthel score was classified as follows: <20 (total dependence), 20-35 (severe dependence), 40-55 (moderate dependence), ≥ 60 (mild dependence), or 100 (independence) registered for preepisode and for discharge in the medical history of the patient, the hospital, or the primary care center]; functional status of the patient at discharge: death, home-autonomous, home address caregiver, referral to another acute hospital, or convalescent center (temporary or long-term stay), and vital status (alive/dead) of the patient, specifying the date (day/month/year) of death, if any.
Statistical Analysis Computerized statistical analysis was undertaken with the following: (1) descriptive basic statistics and standard deviation of key variables stratified by age and sex and (2) differences in functional outcome and its evolution before and after the episode determined the possible effects on mortality and different residual deficits categorized with the statistical Cox regression model. Mortality should be interpreted as overall mortality and cause-specific, no stroke. Patients who died during hospitalization or within the 1st month are considered 'immediate death'. During follow-up the deceased are described as 'subsequent mortality'.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 15 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients were included by using the automated operation of the database of patients with a diagnosis code of stroke (I60-I69).
Key inclusion criteria (4 listed)
- age ≥ 15 up to ≤ 90;
- usual residence in Catalonia
- and/or assignment to any of the catalonian primary care centers for 5 years at the time of the stroke episode;
- a diagnosis of stroke explicitly recorded in their medical record at any of the registration systems in the health centers of the area; it should be a first stroke episode, and relevant episode information should be available in clinical records: (a) outpatient clinic, (b)hospital clinic, or (c) access to medical/sociosanitary reports.
Key exclusion criteria (1 listed)
- intracerebral haemorrhage
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 |
|---|---|---|
| IV thrombolytic (t-PA) treatment vs notAlso: IV thrombolysis, IV thrombolytic (t-PA) treatmentAcute Stroke Protocol | Drug | – |
Primary outcome
Death all causes
Time frame: January 1, 2011 to December 31, 2016
Mortality should be interpreted as overall mortality and cause-specific, no stroke. Patients who died during hospitalization or within the 1st month are considered 'immediate death'. During follow-up the deceased are described as 'subsequent mortality'.
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 11 Apr 2022.
- Background: PubMed 26648964Clua-Espuny JL, Ripolles-Vicente R, Forcadell-Arenas T, Gil-Guillen VF, Queralt-Tomas ML, Gonzalez-Henares MA, Panisello-Tafalla A, Lopez-Pablo C, Lucas-Noll J; Ebrictus Group. Sex Differences in Long-Term Survival after a First Stroke with Intravenous Thrombolysis: Ebrictus Study. Cerebrovasc Dis Extra. 2015 Oct 9;5(3):95-102. doi: 10.1159/000440734. eCollection 2015 Sep-Dec.
- Background: PubMed 24953174Clua-Espuny JL, Ripolles-Vicente R, Lopez-Pablo C, Panisello-Tafalla A, Lucas-Noll J, Calduch-Noll C, Gonzalez-Henares MA, Queralt-Tomas ML. [Differences in the survival after an episode of stroke treated with thrombolytic therapy. Study Ebrictus]. Aten Primaria. 2015 Feb;47(2):108-16. doi: 10.1016/j.aprim.2014.04.008. Epub 2014 Jun 19. Spanish.
- Background: PubMed 27113062Gonzalez-Henares A, Clua-Espuny JL, Gil-Guillen VF, Panisello-Tafalla A, Queralt-Tomas ML, Ripolles-Vicente R, Lopez-Pablo C, Lucas-Noll J, Equipo de Investigacion Ebrictus Ede I. [Incidence and preventability of haemorrhagic strokes. Results of the Ebrictus register]. Rev Neurol. 2016 May 1;62(9):385-95. Spanish.
- Results publication: PubMed 31019638Clua-Espuny JL, Abilleira S, Queralt-Tomas L, Gonzalez-Henares A, Gil-Guillen V, Muria-Subirats E, Ballesta-Ors J. Long-Term Survival After Stroke According to Reperfusion Therapy, Cardiovascular Therapy and Gender. Cardiol Res. 2019 Apr;10(2):89-97. doi: 10.14740/cr839. Epub 2019 Apr 11.
- Results publication: PubMed 22153783Clua-Espuny JL, Pinol-Moreso JL, Gil-Guillen FV, Orozco-Beltran D, Panisello-Tafalla A, Lucas-Noll J. [The stroke care system in Terres de l'Ebre, Spain, after the implementation of the Stroke Code model: Ebrictus Study]. Med Clin (Barc). 2012 May 19;138(14):609-11. doi: 10.1016/j.medcli.2011.10.004. Epub 2011 Dec 6. Spanish.
- Individual participant dataSharing planned: No. Dates files
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke and Thrombolytic (t-PA) Treatment, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site 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 4 inclusion and 1 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 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 all causes (time frame: January 1, 2011 to December 31, 2016). 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 NCT03247036, which also lists 5 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 11 Apr 2022.