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RecruitingNCT03268668COMPO-CLOTUpdated Jan 20, 2026

Thrombus Composition in Ischemic Stroke: Analysis of the Correlation With Plasma Biomarkers, Efficacy of Treatment, Etiology and Prognosis

An observational study in Stroke, Acute, Biological Specimen Banks and Biomarkers, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Recruiting at 12 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-20.

Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
1,200
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Stroke, Acute
  • Biological Specimen Banks
  • Biomarkers
  • Etiology
  • Prognosis

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Adult patients with ischemic stroke

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

  • Patient benefiting from a legal protection measure
  • Pregnant or breastfeeding woman
04

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
1,200 participants (estimated)
Patient registry
No

Interventions

  • OtherCollection of thrombus that is responsible for stroke and blood sample

    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 : 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

05

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 3 months

06

Study locations

11 of 12 sites recruiting
  • CHU de Bordeaux
    Bordeaux, 33000, France
    Recruiting
  • CHU Caen
    Caen, 14000, France
    Recruiting
  • Chu Limoges
    Limoges, 87000, France
    Recruiting
  • CHRU de Nancy
    Nancy, 54000, France
    Recruiting
  • CHU de Nantes
    Nantes, 44093, France
    Recruiting
  • Hôpital Lariboisière AP-HP
    Paris, 75010, France
    Recruiting
  • Centre hospitalier Sainte-Anne
    Paris, 75014, France
    Recruiting
  • Fondation Ophtalmologique A. de Rothschild
    Paris, 75019, France
    Recruiting
  • CHU de Rennes
    Rennes, 35000, France
    Completed
  • Hôpital Foch
    Suresnes, 92150, France
    Recruiting
  • Hôpital d'Instruction des Armées Sainte-Anne
    Toulon, 83000, France
    Recruiting
  • CHRU Tours
    Tours, 37000, France
    Recruiting
07

References and documents

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 ↗

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT03268668
Lead sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Responsible party
Sponsor
First posted
Aug 31, 2017
Start date
Jul 13, 2017
Primary completion
Jul 12, 2027 (estimated)
Completion
Jan 1, 2028 (estimated)
Last update
Jan 20, 2026

Study contacts

Amélie Yavchitz, MD PhD
Contact
ayavchitz@for.paris
0148036454 ext. +33
Jean-Philippe Désilles, MD
Contact
jpdesilles@for.paris
0672872906
Jean-Philippe Désilles, MD
principal investigator · Fondation Ophtalmologique A. de Rothschild

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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