StrokebiostrokeNCT00763217
Clinical Biological and Pharmacological Factors Influencing Stroke Outcome
An observational study of Stroke, run by University Hospital, Lille at 1 site in France.
Trial summary
In a previous suty, we have demonstrated that prior transient ischemic attack, treatment lipid-lowering drug or physical activity are associated to a better outcome of stroke. The aim of the study is to understand the mechanisms of this preventive neuroprotection by establishing link between biomarkers and preventive… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Stroke
- How many people
- 550 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2005to Jun 2012
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cohort of stroke patient
Who may be able to join
- ischemic or hemorrhage stroke
- hemispheric stroke
- stroke dating from less 48h
Who cannot join
- non hemispheric stroke
- malformative intracranial hemorrhage
- traumatic intracranial hemorrhage
- subarachnoidal hemorrhage
Trial locations and contacts
1 site in 1 country.
France1 site
Lille University Hospital - Service de Neurologie vasculaire
Lille
About this study
Official title: Characterization of Clinical, Biological and Pharmacological Markers of Stroke Outcome
In a previous suty, we have demonstrated that prior transient ischemic attack, treatment lipid-lowering drug or physical activity are associated to a better outcome of stroke. The aim of the study is to understand the mechanisms of this preventive neuroprotection by establishing link between biomarkers and preventive and neuroprotective measures.To answer to the question, we conduct a cohort study of stroke patients.
Read the detailed description
In the cohort, the severity of stroke (NIHSS) will be correlated with :
- clinical factors,
- pharmacological factors,
- biological factors (inflammatory markers, hemostasis...)
- Conditions
- Stroke
- Keywords
- inflammation, coagulation, neuroprotection, drugs, clinical neurology, pharmacology, biological factors
- Medical subject headings
- Stroke, Inflammation, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| stroke patient cohort | Patients with an hemispheric ischemic or hemorrhage stroke hospitalized during the 48h following the beginning of stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
severity of stroke measured by NIH severity score
Measured: inclusion, day7, month3, year3
Secondary outcomes (1)
clinical, pharmacological and biological (metabolic, inflammation, hemostasis...) cognitive status
Measured: inclusion and year3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study startJun 2005
- Primary completionJun 2009
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- 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
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- regis BORDET, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00763217
- Sponsor's protocol ID
- CP 05/15
- Other IDs
- PHRC 2004/1901
- Acronym
- biostroke
- Status last verified
- May 2015
- First submitted
- 26 Sep 2008
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Mendyk AM, Labreuche J, Henon H, Girot M, Cordonnier C, Duhamel A, Leys D, Bordet R. Which factors influence the resort to surrogate consent in stroke trials, and what are the patient outcomes in this context? BMC Med Ethics. 2015 Apr 24;16:26. doi: 10.1186/s12910-015-0018-8.
PubMed 25903471Colin O, Labreuche J, Deguil J, Mendyk AM, Deken V, Cordonnier C, Deplanque D, Leys D, Bordet R. Preadmission use of benzodiazepines and stroke outcomes: the Biostroke prospective cohort study. BMJ Open. 2019 Jan 15;9(1):e022720. doi: 10.1136/bmjopen-2018-022720.
PubMed 30782684Moulin S, Leys D, Schraen-Maschke S, Bombois S, Mendyk AM, Muhr-Tailleux A, Cordonnier C, Buee L, Pasquier F, Bordet R. Abeta1-40 and Abeta1-42 Plasmatic Levels In Stroke: Influence of Pre-Existing Cognitive Status and Stroke Characteristics. Curr Alzheimer Res. 2017;14(6):686-694. doi: 10.2174/1567205012666151027141730.
PubMed 26502812
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Clinical, Biological and Pharmacological Markers of Stroke Outcome
- ClinicalTrials.gov ID
- NCT00763217
- Acronym / sponsor ID
- biostroke / CP 05/15
- Conditions
- Stroke
- Keywords
- inflammation, coagulation, neuroprotection, drugs, clinical neurology, pharmacology, biological factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Jun 2005
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 30 Sep 2008 (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.
In a previous suty, we have demonstrated that prior transient ischemic attack, treatment lipid-lowering drug or physical activity are associated to a better outcome of stroke. The aim of the study is to understand the mechanisms of this preventive neuroprotection by establishing link between biomarkers and preventive and neuroprotective measures.To answer to the question, we conduct a cohort study of stroke patients.
Detailed description
In the cohort, the severity of stroke (NIHSS) will be correlated with :
- clinical factors,
- pharmacological factors,
- biological factors (inflammatory markers, hemostasis...)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stroke patient cohort | – | –Patients with an hemispheric ischemic or hemorrhage stroke hospitalized during the 48h following the beginning of stroke |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort of stroke patient
Key inclusion criteria (3 listed)
- ischemic or hemorrhage stroke
- hemispheric stroke
- stroke dating from less 48h
Key exclusion criteria (4 listed)
- non hemispheric stroke
- malformative intracranial hemorrhage
- traumatic intracranial hemorrhage
- subarachnoidal hemorrhage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
severity of stroke measured by NIH severity score
Time frame: inclusion, day7, month3, year3
1 secondary outcome
clinical, pharmacological and biological (metabolic, inflammation, hemostasis...) cognitive status
Time frame: inclusion and year3
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 14 May 2026.
- Results publication: PubMed 25903471Mendyk AM, Labreuche J, Henon H, Girot M, Cordonnier C, Duhamel A, Leys D, Bordet R. Which factors influence the resort to surrogate consent in stroke trials, and what are the patient outcomes in this context? BMC Med Ethics. 2015 Apr 24;16:26. doi: 10.1186/s12910-015-0018-8.
- Derived from this study: PubMed 30782684Colin O, Labreuche J, Deguil J, Mendyk AM, Deken V, Cordonnier C, Deplanque D, Leys D, Bordet R. Preadmission use of benzodiazepines and stroke outcomes: the Biostroke prospective cohort study. BMJ Open. 2019 Jan 15;9(1):e022720. doi: 10.1136/bmjopen-2018-022720.
- Derived from this study: PubMed 26502812Moulin S, Leys D, Schraen-Maschke S, Bombois S, Mendyk AM, Muhr-Tailleux A, Cordonnier C, Buee L, Pasquier F, Bordet R. Abeta1-40 and Abeta1-42 Plasmatic Levels In Stroke: Influence of Pre-Existing Cognitive Status and Stroke Characteristics. Curr Alzheimer Res. 2017;14(6):686-694. doi: 10.2174/1567205012666151027141730.
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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.
regis BORDET, MD,PhD principal investigator
University Hospital, Lille
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 Stroke, run by University Hospital, Lille at 1 site in France.
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 4 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 14 May 2026. 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 France. 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?
severity of stroke measured by NIH severity score (time frame: inclusion, day7, month3, year3). 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 NCT00763217, which also lists 3 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 14 May 2026.