NCT02907736

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
withdrawn

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 Start

First participant enrolled

November 12, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

March 19, 2018

Status Verified

March 1, 2018

Enrollment Period

1.6 years

First QC Date

September 6, 2016

Last Update Submit

March 16, 2018

Conditions

Outcome Measures

Primary Outcomes (4)

  • thrombus origin

    according to the etiology of the stroke (TOAST classification)

    baseline

  • red cells counts

    quantitative assessment of the relative fractions of the main constituents after Hematoxylin and Eosin staining :

    baseline

  • white cells counts

    quantitative assessment of the relative fractions of the main constituents after Hematoxylin and Eosin staining

    baseline

  • platlet counts

    quantitative assessment of the relative fractions of the main constituents after Hematoxylin and Eosin staining

    baseline

Eligibility Criteria

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

Patients with acute stroke, admitted for endovascular therapy.

You may qualify if:

  • age \> 18 years old
  • AIS secondary to a large vessel occlusion
  • admitted 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)

  • Ducroux C, Di Meglio L, Loyau S, Delbosc S, Boisseau W, Deschildre C, Ben Maacha M, Blanc R, Redjem H, Ciccio G, Smajda S, Fahed R, Michel JB, Piotin M, Salomon L, Mazighi M, Ho-Tin-Noe B, Desilles JP. Thrombus Neutrophil Extracellular Traps Content Impair tPA-Induced Thrombolysis in Acute Ischemic Stroke. Stroke. 2018 Mar;49(3):754-757. doi: 10.1161/STROKEAHA.117.019896. Epub 2018 Feb 8.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Jean-Philippe Désilles, MD

    Fondation OPH A. de Rothschild

    PRINCIPAL INVESTIGATOR
  • Mikael Mazighi, MD, PhD

    Fondation OPH A. de Rothschild

    STUDY CHAIR
0

Study Design

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

Study Record Dates

First Submitted

September 6, 2016

First Posted

September 20, 2016

Study Start

November 12, 2015

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

March 19, 2018

Record last verified: 2018-03

Locations