Stroke, AcuteCOMPO-CLOTNCT03268668
Thrombus Composition in Ischemic Stroke: Analysis of the Correlation With Plasma Biomarkers, Efficacy of Treatment, Etiology and Prognosis
An observational study of Stroke, Acute and Biological Specimen Banks, run by Fondation Ophtalmologique Adolphe de Rothschild at 12 sites in France.
Trial summary
The recent validation of thrombectomy in addition to thrombolysis with intravenous administration of alteplase suggests a major revolution in the management of acute strokes. This treatment option also opens up a new field of research, making possible the analysis of the clot responsible for intracranial occlusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute, Biological Specimen Banks, Biomarkers
- What is being tested?
- Collection of thrombus that is responsible for stroke and blood sample
- How many people
- 1,200 participants
- Where
- 12 sitesFrance
- Study dates
- 13 Jul 2017to 1 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adult patients with ischemic stroke
Who may be able to join
- Patients aged 18 years and older
- Presenting with cerebral infarction following arterial occlusion
- Treated for mechanical thrombectomy (whether performed or not)
- Free, informed, and express consent of the patient or their relatives (emergency inclusion procedure)
- For retrospective patients: thrombus already collected (according to the center's usual practice or for another research project).
Who cannot join
- Patient benefiting from a legal protection measure
- Pregnant or breastfeeding woman
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
France12 sites, 11 recruiting
- Recruiting
CHU de Bordeaux
Bordeaux, 33000
Gaultier MARNAT, MD, 05 56 79 56 79 ext. + 33, gaultier.marnat@chu-bordeaux.fr
- Recruiting
CHU Caen
Caen, 14000
Charlotte Barbier, MD, 02 31 06 46 91 ext. + 33, barbier-ch@chu-caen.fr
- Recruiting
Chu Limoges
Limoges, 87000
Aymeric ROUCHAUD, Pr, 05 55 05 80 11 ext. + 33, AYMERIC.ROUCHAUD2@chu-limoges.fr
- Recruiting
CHRU de Nancy
Nancy, 54000
Benjamin GORY, Pr, 03 83 85 95 27 ext. + 33, b.gory@chru-nancy.fr
- Recruiting
CHU de Nantes
Nantes, 44093
Romain BOURCIER, MD, 02 40 16 56 08 ext. +33, Romain.BOURCIER@chu-nantes.fr
- Recruiting
Hôpital Lariboisière AP-HP
Paris, 75010
Alexis GUEDON, MD, 01 49 95 81 17 ext. + 33, alexis.guedon@aphp.fr
- Recruiting
Centre hospitalier Sainte-Anne
Paris, 75014
Olivier NAGGARA, MD, 01 45 65 80 00 ext. + 33, o.naggara@ghu-paris.fr
- Recruiting
Fondation Ophtalmologique A. de Rothschild
Paris, 75019
Jean-Philippe DESILLES, Pr, 01 48 03 69 13 ext. +33, jpdesilles@for.paris
- Completed
CHU de Rennes
Rennes, 35000
- Recruiting
Hôpital Foch
Suresnes, 92150
Arthur CONSOLI, MD, 01 46 25 20 00 ext. +33, a.consoli@hopital-foch.com
- Recruiting
Hôpital d'Instruction des Armées Sainte-Anne
Toulon, 83000
Quentin HOLAY, MD, 04 83 16 21 95 ext. + 33, quentin.holay@intradel.gouv.fr
- Recruiting
CHRU Tours
Tours, 37000
Héloïse IFERGAN, MD, 02 47 47 47 47 ext. + 33, h.ifergan@chu-tours.fr
About this study
The recent validation of thrombectomy in addition to thrombolysis with intravenous administration of alteplase suggests a major revolution in the management of acute strokes. This treatment option also opens up a new field of research, making possible the analysis of the clot responsible for intracranial occlusion. Indeed, in about 30% of the cases, the thrombectomy procedure makes it possible to retrieve either partially or completely the clot. Previous studies have analyzed the correlation between the composition of the thrombus and the etiology of stroke. Their discordant results do not yet make it possible to distinguish a particular profile of thrombus according to etiology. Other studies have shown a correlation between the proportion of red blood cells in a thrombus and the likelihood that it is visible in MRI or cerebral scanning. More recently, one study has demonstrated a correlation between the presence of lymphocytes in the thrombus and an atheromatous etiology.
The main limitations of these studies are the small number of patients included, the high variability of conservation protocols and the absence of plasma data, which does not allow for research on the correlation between clot composition and plasma biomarkers.
- Conditions
- Stroke, Acute, Biological Specimen Banks, Biomarkers, Etiology, Prognosis
- Being tested
- Collection of thrombus that is responsible for stroke and blood sample
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of thrombus that is responsible for stroke and blood sampleOther
A blood sample (venous or arterial) of 10 ml will be made, on ethylene Diamine Tetra-Acetic (EDTA) tube (5 ml) and citrate (5 ml).Thrombus resulting from thrombectomy will be collected at the end of the procedure. The samples will be transferred to a biobank. Treatment efficacy, etiology and prognosis of patients will be assessed using the following criteria :
- TOAST score (etiology) B) TICI score (status of final recanalization) C) Extravasation of contrast agent on post-intervention CT (rupture of the blood-brain barrier :yes/no) D) Symptomatic haemorrhagic transformation corresponding to an increase > 4 of the NIHSS score due to a haemorrhagic transformation identified on brain imaging 24 hours after stroke E) Decreased NIHSS score by 8 points or NIHSS score = 0 24 hours after stroke (improved neurological status: yes/no) F) Modified RANKIN score (mRS) measured at 3 months evaluating neurological prognosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the composition of the thrombus responsible for stroke, the plasma composition and the stroke characteristics (etiology, response to treatment, prognosis).
Since this is an observational, exploratory study that correlates laboratory data (eg for thrombus: fibrinolytic, pro-oxidant activity, eg for blood: plasma fibrinolysis markers, presence of factor Von Willebrand, etc.) and clinical data (characteristics of the stroke, including the TOAST etiological score, the TICI score (TICI = thrombolysis in cerebral infarction), the NIHSS score, etc.), there is no single primary endpoint.
Clinical data will be collected up to 3 months after stroke (Rankin score).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start13 Jul 2017
- Primary completion12 Jul 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
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 Stroke, AcuteStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,200 participants (estimated)
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 Ophtalmologique A. de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03268668
- Sponsor's protocol ID
- JDS_2017_8
- Acronym
- COMPO-CLOT
- Status last verified
- Jan 2026
- First submitted
- 29 Aug 2017
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Di Meglio L, Desilles JP, Solonomenjanahary M, Labreuche J, Ollivier V, Dupont S, Deschildre C, Maacha MB, Consoli A, Lapergue B, Piotin M, Blanc R, Ho-Tin-Noe B, Mazighi M; compoCLOT study groupdagger. DNA Content in Ischemic Stroke Thrombi Can Help Identify Cardioembolic Strokes Among Strokes of Undetermined Cause. Stroke. 2020 Sep;51(9):2810-2816. doi: 10.1161/STROKEAHA.120.029134. Epub 2020 Aug 19.
PubMed 32811390
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thrombus Composition in Ischemic Stroke: Analysis of the Correlation With Plasma Biomarkers, Efficacy of Treatment, Etiology and Prognosis
- ClinicalTrials.gov ID
- NCT03268668
- Acronym / sponsor ID
- COMPO-CLOT / JDS_2017_8
- Conditions
- Stroke, Acute, Biological Specimen Banks, Biomarkers, Etiology, Prognosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 13 Jul 2017 (actual)
- Primary completion
- 12 Jul 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 31 Aug 2017 (actual)
- 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.
The recent validation of thrombectomy in addition to thrombolysis with intravenous administration of alteplase suggests a major revolution in the management of acute strokes. This treatment option also opens up a new field of research, making possible the analysis of the clot responsible for intracranial occlusion. Indeed, in about 30% of the cases, the thrombectomy procedure makes it possible to retrieve either partially or completely the clot. Previous studies have analyzed the correlation between the composition of the thrombus and the etiology of stroke. Their discordant results do not yet make it possible to distinguish a particular profile of thrombus according to etiology. Other studies have shown a correlation between the proportion of red blood cells in a thrombus and the likelihood that it is visible in MRI or cerebral scanning. More recently, one study has demonstrated a correlation between the presence of lymphocytes in the thrombus and an atheromatous etiology.
The main limitations of these studies are the small number of patients included, the high variability of conservation protocols and the absence of plasma data, which does not allow for research on the correlation between clot composition and plasma biomarkers.
Study design
- Observational model
- Case only
- 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
- Adult patients with ischemic stroke
Key inclusion criteria (5 listed)
- Patients aged 18 years and older
- Presenting with cerebral infarction following arterial occlusion
- Treated for mechanical thrombectomy (whether performed or not)
- Free, informed, and express consent of the patient or their relatives (emergency inclusion procedure)
- For retrospective patients: thrombus already collected (according to the center's usual practice or for another research project).
Key exclusion criteria (2 listed)
- Patient benefiting from a legal protection measure
- Pregnant or breastfeeding woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of thrombus that is responsible for stroke and blood sampleA blood sample (venous or arterial) of 10 ml will be made, on ethylene Diamine Tetra-Acetic (EDTA) tube (5 ml) and citrate (5 ml).Thrombus resulting from thrombectomy will be collected at the end of the procedure. The samples will be transferred to a biobank. Treatment efficacy, etiology and prognosis of patients will be assessed using the following criteria : A) TOAST score (etiology) B) TICI score (status of final recanalization) C) Extravasation of contrast agent on post-intervention CT (rupture of the blood-brain barrier :yes/no) D) Symptomatic haemorrhagic transformation corresponding to an increase > 4 of the NIHSS score due to a haemorrhagic transformation identified on brain imaging 24 hours after stroke E) Decreased NIHSS score by 8 points or NIHSS score = 0 24 hours after stroke (improved neurological status: yes/no) F) Modified RANKIN score (mRS) measured at 3 months evaluating neurological prognosis | Other | – |
Primary outcome
Correlation between the composition of the thrombus responsible for stroke, the plasma composition and the stroke characteristics (etiology, response to treatment, prognosis).
Time frame: 3 months
Since this is an observational, exploratory study that correlates laboratory data (eg for thrombus: fibrinolytic, pro-oxidant activity, eg for blood: plasma fibrinolysis markers, presence of factor Von Willebrand, etc.) and clinical data (characteristics of the stroke, including the TOAST etiological score, the TICI score (TICI = thrombolysis in cerebral infarction), the NIHSS score, etc.), there is no single primary endpoint. Clinical data will be collected up to 3 months after stroke (Rankin score).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Derived from this study: PubMed 32811390Di Meglio L, Desilles JP, Solonomenjanahary M, Labreuche J, Ollivier V, Dupont S, Deschildre C, Maacha MB, Consoli A, Lapergue B, Piotin M, Blanc R, Ho-Tin-Noe B, Mazighi M; compoCLOT study groupdagger. DNA Content in Ischemic Stroke Thrombi Can Help Identify Cardioembolic Strokes Among Strokes of Undetermined Cause. Stroke. 2020 Sep;51(9):2810-2816. doi: 10.1161/STROKEAHA.120.029134. Epub 2020 Aug 19.
- Individual participant dataSharing planned: No
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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.
Jean-Philippe Désilles, MD principal investigator
Fondation Ophtalmologique A. de Rothschild
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Acute and Biological Specimen Banks, run by Fondation Ophtalmologique Adolphe de Rothschild at 12 sites 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 5 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: looking for participants now, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amélie Yavchitz, MD PhD (0148036454 ext. +33, ayavchitz@for.paris), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between the composition of the thrombus responsible for stroke, the plasma composition and the stroke characteristics (etiology, response to treatment, prognosis). (time frame: 3 months). 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 NCT03268668, 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 20 Jan 2026; AzTrials last refreshed its copy on 3 Nov 2026.