NCT02860260

Brief Summary

The aim of this study is to show for the first time that treatment with intravenous fibrinolysis using rt-PA in patients with recent ischemic stroke is accompanied by increases in circulating levels of BDNF, which may reflect an increase in BDNF synthesis in the brain. The analysis of the recovery of functional and cognitive abilities as well as mood at 3 months will allow us to study the impact of BDNF on these parameters. Thus, depending on the results obtained, circulating BDNF could serve as an early marker of these.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 9, 2016

Completed
Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

11 months

First QC Date

August 1, 2016

Last Update Submit

March 10, 2026

Conditions

Keywords

BDNF

Outcome Measures

Primary Outcomes (2)

  • Measurement of plasma levels of BDNF

    Change from baseline at Day1, Day 7 and Month 3

  • Measurement of serum levels of BDNF

    Change from baseline at Day1, Day 7 and Month 3

Study Arms (2)

Patients with fibrinolysis

EXPERIMENTAL
Biological: Blood samplesOther: Cerebral MRI

Patients without fibrinolysis

PLACEBO COMPARATOR
Biological: Blood samplesOther: Cerebral MRI

Interventions

Blood samplesBIOLOGICAL
Patients with fibrinolysisPatients without fibrinolysis
Patients with fibrinolysisPatients without fibrinolysis

Eligibility Criteria

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

You may qualify if:

  • Patients (or their person of trust in cases of inability) who have been informed about the research and given their consent to take part
  • Patients aged 18 years or older
  • Patients who have suffered a de novo recent ischemic stroke \< 12 hours
  • Patients who had cerebral imaging (CT-Scan or MRI)
  • Ischemic stroke severity, measured by the National Institute of Health Stroke Score (NIHSS), between 4 and 20

You may not qualify if:

  • Patients without national health insurance cover
  • Patients with a clinical history of stroke
  • Patients with cerebral or sub-arachnoid haemorrhage
  • Patients with a transient ischemic attack
  • Time of symptom onset unknown
  • Patients with severe aphasia at the time of the ischemic stroke defined by a sub-score for item 9 (best language) of the NIHSS ≥ 2
  • Patients with dementia prior to the ischemic stroke
  • Patients with a significant loss of autonomy prior to the ischemic stroke, defined by a Rankin score ≥ 4
  • Patients with aphasia before the ischemic stroke
  • Patients with a contra-indication for cerebral MRI
  • Pregnant or breast-feeding women
  • Adults under guardianship
  • Subjects in custody
  • Patients who do not speak French

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire

Dijon, 21079, France

Location

Related Publications (1)

  • Rodier M, Quirie A, Prigent-Tessier A, Bejot Y, Jacquin A, Mossiat C, Marie C, Garnier P. Relevance of Post-Stroke Circulating BDNF Levels as a Prognostic Biomarker of Stroke Outcome. Impact of rt-PA Treatment. PLoS One. 2015 Oct 15;10(10):e0140668. doi: 10.1371/journal.pone.0140668. eCollection 2015.

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2016

First Posted

August 9, 2016

Study Start

February 1, 2011

Primary Completion

January 1, 2012

Last Updated

March 12, 2026

Record last verified: 2026-03

Locations