Acute StrokeTHROMBONETSNCT02907736
Impact of Neutrophil Extracellular Traps on Tissue Plasminogen Activator Induced Thrombolysis in Acute Ischemic Stroke Patients
An observational study of Acute Stroke, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stroke
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 12 Nov 2015to 1 Jul 2017
- 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 stroke, admitted for endovascular therapy.
Who may be able to join
- age > 18 years old
- AIS secondary to a large vessel occlusion
- admitted 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
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.
- Conditions
- Acute Stroke
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
thrombus origin
according to the etiology of the stroke (TOAST classification)
Measured: baseline
red cells counts
quantitative assessment of the relative fractions of the main constituents after Hematoxylin and Eosin staining :
Measured: baseline
white cells counts
quantitative assessment of the relative fractions of the main constituents after Hematoxylin and Eosin staining
Measured: baseline
platlet counts
quantitative assessment of the relative fractions of the main constituents after Hematoxylin and Eosin staining
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study start12 Nov 2015
- Primary completion1 Jul 2017
- Study completion1 Jul 2017
Why it stopped: replaced by a new study
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jean-Philippe Désilles, 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
- NCT02907736
- Sponsor's protocol ID
- JDS_2015_45
- Acronym
- THROMBONETS
- Status last verified
- Mar 2018
- First submitted
- 6 Sep 2016
- Last updated
- 19 Mar 2018
- Results posted
- No
Publications
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.
PubMed 29438080
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Neutrophil Extracellular Traps on Tissue Plasminogen Activator Induced Thrombolysis in Acute Ischemic Stroke Patients
- ClinicalTrials.gov ID
- NCT02907736
- Acronym / sponsor ID
- THROMBONETS / JDS_2015_45
- Conditions
- Acute Stroke
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: replaced by a new study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 12 Nov 2015 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 20 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.
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 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 stroke, admitted for endovascular therapy.
Key inclusion criteria (3 listed)
- age > 18 years old
- AIS secondary to a large vessel occlusion
- admitted for endovascular therapy.
Key exclusion criteria (2 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
thrombus origin
Time frame: baseline
according to the etiology of the stroke (TOAST classification)
red cells counts
Time frame: baseline
quantitative assessment of the relative fractions of the main constituents after Hematoxylin and Eosin staining :
white cells counts
Time frame: baseline
quantitative assessment of the relative fractions of the main constituents after Hematoxylin and Eosin staining
platlet counts
Time frame: baseline
quantitative assessment of the relative fractions of the main constituents after Hematoxylin and Eosin staining
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2018.
- Derived from this study: PubMed 29438080Ducroux 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.
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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 Désilles, 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 2 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: withdrawn, as of the sponsor's last update on 19 Mar 2018. 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 was withdrawn before enrolling participants, so there are no results.
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?
thrombus origin (time frame: baseline). The study lists 4 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 NCT02907736, 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 19 Mar 2018.