- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02907736
Impact of Neutrophil Extracellular Traps on Tissue Plasminogen Activator Induced Thrombolysis in Acute Ischemic Stroke Patients (THROMBONETS)
Acute Ischemic stroke (AIS) remains a leading cause of adult disability, cognitive impairment and mortality worldwide despite the development of revascularization therapies (intravenous Tissue Plasminogen Activator (t-PA) and endovascular therapy). Thrombosis resistance after IV t-PA therapy is frequent especially in case of AIS with proximal occlusion. In recent years, neutrophil extracellular traps (NETs) have been identified as major triggers and structural factors of various forms of thrombosis. NETs are extracellular webs primarily composed of DNA from neutrophils. A recent study shows that the NETs burden in coronary thrombi is positively correlated with the infarct size and negatively correlated with electrocardiogram (ST-segment) resolution. This later study revealed that in vitro addition of DNase I accelerated the t-PA-induced thrombolysis of coronary thrombi. NETs could, in consequence, be promising targets for improved thrombolysis in AIS.
The aim of this study is to assess the impact of NETs composition of thrombi retrieved during endovascular therapy in AIS patients on IV t-PA induced thrombolysis, clinical outcome and AIS etiologies.
Study Overview
Status
Conditions
Study Type
Contacts and Locations
Study Locations
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-
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Paris, France, 75019
- Fondation Ophtalmologique Adolphe de Rothschild
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- age > 18 years old
- AIS secondary to a large vessel occlusion
- admitted for endovascular therapy.
Exclusion Criteria:
- Pregnant or breast feeding patient patient under legal protection
- Patient opposition to participate in this study
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
thrombus origin
Time Frame: baseline
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according to the etiology of the stroke (TOAST classification)
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baseline
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red cells counts
Time Frame: baseline
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quantitative assessment of the relative fractions of the main constituents after Hematoxylin and Eosin staining :
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baseline
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white cells counts
Time Frame: baseline
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quantitative assessment of the relative fractions of the main constituents after Hematoxylin and Eosin staining
|
baseline
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platlet counts
Time Frame: baseline
|
quantitative assessment of the relative fractions of the main constituents after Hematoxylin and Eosin staining
|
baseline
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jean-Philippe Désilles, MD, Fondation OPH A. de Rothschild
- Study Chair: Mikael Mazighi, MD, PhD, Fondation OPH A. de Rothschild
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JDS_2015_45
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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