Clinical Biological and Pharmacological Factors Influenci... | NCT00763217

Studies
Clinical Biological and Pharmacological Factors Influencing Stroke Outcome

NCT00763217

Sponsor

University Hospital, Lille

Status

Completed

Last Update Posted

May 14, 2026Actual

Enrollment

550Actual

Phase

Not provided

Conditions

Stroke

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
PHRC 2004/1901	Other Identifier	DHOS

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2005

Primary Completion Date

Jun 2009Actual

Completion Date

Jun 2012Actual

First Submitted Date

Sep 26, 2008

First Submission Date that Met QC Criteria

Sep 29, 2008

First Posted Date

Sep 30, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 11, 2026

Last Update Posted Date

May 14, 2026Actual

Name	Class
Institut National de la Santé Et de la Recherche Médicale, France	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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...)

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

550Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
stroke patient cohort		Patients with an hemispheric ischemic or hemorrhage stroke hospitalized during the 48h following the beginning of stroke

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
severity of stroke measured by NIH severity score		inclusion, day7, month3, year3

Secondary Outcomes

Measure	Description	Time Frame
clinical, pharmacological and biological (metabolic, inflammation, hemostasis...) cognitive status		inclusion and year3

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ischemic or hemorrhage stroke
hemispheric stroke
stroke dating from less 48h

Exclusion Criteria:

non hemispheric stroke
malformative intracranial hemorrhage
traumatic intracranial hemorrhage
subarachnoidal hemorrhage

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Cohort of stroke patient

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
regis BORDET, MD,PhD	University Hospital, Lille	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lille University Hospital - Service de Neurologie vasculaire		Lille			France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25903471	Result	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.
30782684	Derived	Colin 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.

ID	Term
D020521	Stroke
D007249	Inflammation
D013927	Thrombosis

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases