NCT02900833

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
440

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Mar 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Mar 2016Aug 2026

Study Start

First participant enrolled

March 24, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 14, 2016

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2022

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Expected
Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

6.7 years

First QC Date

September 7, 2016

Last Update Submit

January 16, 2026

Conditions

Acute Stroke

Outcome Measures

Primary Outcomes (19)

  • neutrophil counts

    Plasma neutrophil activation bio-markers

    before recanalization

  • neutrophil counts

    Plasma neutrophil activation bio-markers

    immediately after recanalization

  • neutrophil counts

    Plasma neutrophil activation bio-markers

    24 hours after recanalization

  • neutrophil protease counts

    before recanalization

  • recanalization score

    Thrombolysis in Cerebral Infarction classification (TICI)

    immediately after endovascular procedure

  • acute ischemic stroke etiology

    as defined by the Trial of Danaparoid (ORG10172) in Acute Stroke Treatment (TOAST classification)

    within 24 hours after endovascular procedure

  • severity of neurologic symptoms

    National Institutes of Health Stroke Scale (NIHSS)

    baseline

  • disruption of the blood-brain-barrier

    diagnosis on cerebral Computerized Tomography

    within 24 hours after endovascular procedure

  • brain haemorrhage

    National Institutes of Health Stroke Scale (NIHSS)

    24 hours after endovascular procedure

  • Recovery of motor function after stroke

    modified Rankin scale

    3 months

  • mortality

    3 months

  • adhesion molecules counts

    before recanalization

  • adhesion molecules counts

    immediately after recanalization

  • adhesion molecules counts

    24 hours after recanalization

  • free plasma DNA counts

    before recanalization

  • free plasma DNA counts

    immediately after recanalization

  • free plasma DNA counts

    24 hours after recanalization

  • neutrophil protease counts

    immediately after recanalization

  • neutrophil protease counts

    24 hours after recanalization

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with acute ischemic stroke secondary to a large vessel occlusion, undergoing endovascular therapy.

You may qualify if:

  • age \>= 18 years old
  • acute ischemic stroke secondary to a large vessel occlusion.
  • Patients hospitalized for endovascular therapy.

You may not qualify if:

  • Pregnant or breast feeding patient
  • patient under legal protection
  • Patient opposition to participate in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Ophtalmologique Adolphe de Rothschild

Paris, 75019, France

Location

Related Publications (1)

  • 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.

    PMID: 38845167DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Jean-Philippe DESILLES, MD

    Fondation OPH A de Rothschild

    PRINCIPAL INVESTIGATOR

  • Mikael MAZIGHI, MD, PhD

    Fondation OPH A de Rothschild

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2016

First Posted

September 14, 2016

Study Start

March 24, 2016

Primary Completion

December 12, 2022

Study Completion (Estimated)

August 31, 2026

Last Updated

January 20, 2026

Record last verified: 2026-01

Locations

FR(1)