Impact of Neutrophil Activation in Acute Ischemic Stroke Patients Treated With Endovascular Therapy

Active, not recruiting

• Conditions: Acute Stroke

• Registration Number: NCT02900833
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-24
• Study First Submitted: 2016-09-07
• Study First Submitted QC: 2016-09-09
• Study First Posted: 2016-09-14
• Primary Completion: 2022-12-12
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-17
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 440

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
acute ischemic stroke etiology	within 24 hours after endovascular procedure	as defined by the Trial of Danaparoid (ORG10172) in Acute Stroke Treatment (TOAST classification)
mortality	3 months
severity of neurologic symptoms	baseline	National Institutes of Health Stroke Scale (NIHSS)
neutrophil protease counts	24 hours after recanalization
neutrophil counts	24 hours after recanalization	Plasma neutrophil activation bio-markers
disruption of the blood-brain-barrier	within 24 hours after endovascular procedure	diagnosis on cerebral Computerized Tomography
Recovery of motor function after stroke	3 months	modified Rankin scale
recanalization score	immediately after endovascular procedure	Thrombolysis in Cerebral Infarction classification (TICI)
brain haemorrhage	24 hours after endovascular procedure	National Institutes of Health Stroke Scale (NIHSS)
free plasma DNA counts	24 hours after recanalization
adhesion molecules counts	24 hours after recanalization

Trial Locations

Locations (1)

Fondation Ophtalmologique Adolphe de Rothschild; 🇫🇷 Paris, France