Acute StrokeNEUTROSTROKENCT02900833
Impact of Neutrophil Activation in Acute Ischemic Stroke Patients Treated With Endovascular Therapy
An observational study of Acute Stroke, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Clinical and experimental data suggest that neutrophil activation and extravasation are deleterious in acute ischemic stroke (AIS) involving an increased risk of unfavorable outcome and hemorrhagic transformation (HT). However, clinical trials targeting neutrophil recruitment in AIS patients were negative. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stroke
- How many people
- 440 participants
- Where
- 1 siteFrance
- Study dates
- 24 Mar 2016to 19 Jun 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute ischemic stroke secondary to a large vessel occlusion, undergoing endovascular therapy.
Who may be able to join
- age >= 18 years old
- acute ischemic stroke secondary to a large vessel occlusion.
- Patients hospitalized for endovascular therapy.
Who cannot join
- Pregnant or breast feeding patient
- patient under legal protection
- Patient opposition to participate in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neutrophil Activation in Acute Ischemic Stroke Patients Treated With Endovascular Therapy
Clinical and experimental data suggest that neutrophil activation and extravasation are deleterious in acute ischemic stroke (AIS) involving an increased risk of unfavorable outcome and hemorrhagic transformation (HT). However, clinical trials targeting neutrophil recruitment in AIS patients were negative. Recently, an experimental study has shown that neutrophil activation and transmigration begin immediately after the occlusion. Inhibition of neutrophil recruitment several hours after the start of ischemia appears therefore too late to have a clinical relevance.
The objective is to study the time dependent impact of neutrophils in AIS and the predominant mediators in each time point to identify the appropriate therapeutic target and time window.
- Conditions
- Acute Stroke
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
neutrophil counts
Plasma neutrophil activation bio-markers
Measured: before recanalization
neutrophil counts
Plasma neutrophil activation bio-markers
Measured: immediately after recanalization
neutrophil counts
Plasma neutrophil activation bio-markers
Measured: 24 hours after recanalization
neutrophil protease counts
Measured: before recanalization
recanalization score
Thrombolysis in Cerebral Infarction classification (TICI)
Measured: immediately after endovascular procedure
acute ischemic stroke etiology
as defined by the Trial of Danaparoid (ORG10172) in Acute Stroke Treatment (TOAST classification)
Measured: within 24 hours after endovascular procedure
severity of neurologic symptoms
National Institutes of Health Stroke Scale (NIHSS)
Measured: baseline
disruption of the blood-brain-barrier
diagnosis on cerebral Computerized Tomography
Measured: within 24 hours after endovascular procedure
brain haemorrhage
National Institutes of Health Stroke Scale (NIHSS)
Measured: 24 hours after endovascular procedure
Recovery of motor function after stroke
modified Rankin scale
Measured: 3 months
mortality
Measured: 3 months
adhesion molecules counts
Measured: before recanalization
adhesion molecules counts
Measured: immediately after recanalization
adhesion molecules counts
Measured: 24 hours after recanalization
free plasma DNA counts
Measured: before recanalization
free plasma DNA counts
Measured: immediately after recanalization
free plasma DNA counts
Measured: 24 hours after recanalization
neutrophil protease counts
Measured: immediately after recanalization
neutrophil protease counts
Measured: 24 hours after recanalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study start24 Mar 2016
- Primary completion12 Dec 2022
- Study completion19 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jean-Philippe DESILLES, MD, Principal investigator, Fondation OPH A de RothschildMikael MAZIGHI, MD, PhD, Study chair, Fondation OPH A de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02900833
- Sponsor's protocol ID
- JDS_2015_46
- Acronym
- NEUTROSTROKE
- Status last verified
- Jul 2026
- First submitted
- 7 Sep 2016
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Boutelier A, Ollivier V, Mazighi M, Kyheng M, Labreuche J, Brikci-Nigassa N, Solo Nomenjanahary M, Delvoye F, Maier B, Paquet C, Ho-Tin-Noe B, Desilles JP. Acute astrocytic reaction is associated with 3-month functional outcome after stroke treated with endovascular therapy. Eur Stroke J. 2024 Dec;9(4):952-958. doi: 10.1177/23969873241256813. Epub 2024 Jun 6.
PubMed 38845167
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neutrophil Activation in Acute Ischemic Stroke Patients Treated With Endovascular Therapy
- ClinicalTrials.gov ID
- NCT02900833
- Acronym / sponsor ID
- NEUTROSTROKE / JDS_2015_46
- Conditions
- Acute Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 24 Mar 2016 (actual)
- Primary completion
- 12 Dec 2022 (actual)
- Study completion
- 19 Jun 2026 (actual)
- First posted
- 14 Sep 2016 (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.
Clinical and experimental data suggest that neutrophil activation and extravasation are deleterious in acute ischemic stroke (AIS) involving an increased risk of unfavorable outcome and hemorrhagic transformation (HT). However, clinical trials targeting neutrophil recruitment in AIS patients were negative. Recently, an experimental study has shown that neutrophil activation and transmigration begin immediately after the occlusion. Inhibition of neutrophil recruitment several hours after the start of ischemia appears therefore too late to have a clinical relevance.
The objective is to study the time dependent impact of neutrophils in AIS and the predominant mediators in each time point to identify the appropriate therapeutic target and time window.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute ischemic stroke secondary to a large vessel occlusion, undergoing endovascular therapy.
Key inclusion criteria (3 listed)
- age >= 18 years old
- acute ischemic stroke secondary to a large vessel occlusion.
- Patients hospitalized for endovascular therapy.
Key exclusion criteria (3 listed)
- Pregnant or breast feeding patient
- patient under legal protection
- Patient opposition to participate in this study
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
neutrophil counts
Time frame: before recanalization
Plasma neutrophil activation bio-markers
neutrophil counts
Time frame: immediately after recanalization
Plasma neutrophil activation bio-markers
neutrophil counts
Time frame: 24 hours after recanalization
Plasma neutrophil activation bio-markers
neutrophil protease counts
Time frame: before recanalization
recanalization score
Time frame: immediately after endovascular procedure
Thrombolysis in Cerebral Infarction classification (TICI)
acute ischemic stroke etiology
Time frame: within 24 hours after endovascular procedure
as defined by the Trial of Danaparoid (ORG10172) in Acute Stroke Treatment (TOAST classification)
severity of neurologic symptoms
Time frame: baseline
National Institutes of Health Stroke Scale (NIHSS)
disruption of the blood-brain-barrier
Time frame: within 24 hours after endovascular procedure
diagnosis on cerebral Computerized Tomography
brain haemorrhage
Time frame: 24 hours after endovascular procedure
National Institutes of Health Stroke Scale (NIHSS)
Recovery of motor function after stroke
Time frame: 3 months
modified Rankin scale
mortality
Time frame: 3 months
adhesion molecules counts
Time frame: before recanalization
adhesion molecules counts
Time frame: immediately after recanalization
adhesion molecules counts
Time frame: 24 hours after recanalization
free plasma DNA counts
Time frame: before recanalization
free plasma DNA counts
Time frame: immediately after recanalization
free plasma DNA counts
Time frame: 24 hours after recanalization
neutrophil protease counts
Time frame: immediately after recanalization
neutrophil protease counts
Time frame: 24 hours after recanalization
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 6 Jul 2026.
- Derived from this study: PubMed 38845167Boutelier A, Ollivier V, Mazighi M, Kyheng M, Labreuche J, Brikci-Nigassa N, Solo Nomenjanahary M, Delvoye F, Maier B, Paquet C, Ho-Tin-Noe B, Desilles JP. Acute astrocytic reaction is associated with 3-month functional outcome after stroke treated with endovascular therapy. Eur Stroke J. 2024 Dec;9(4):952-958. doi: 10.1177/23969873241256813. Epub 2024 Jun 6.
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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.
Jean-Philippe DESILLES, MD principal investigator
Fondation OPH A de Rothschild
Mikael MAZIGHI, MD, PhD study chair
Fondation OPH A de Rothschild
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 Acute Stroke, run by Fondation Ophtalmologique Adolphe de Rothschild 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 3 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 6 Jul 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?
neutrophil counts (time frame: before recanalization). The study lists 19 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 NCT02900833, which also lists 1 linked publication.
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 6 Jul 2026.