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AzTrials

Cryptogenic Ischemic StrokePhase 3CLOSE-2NCT05387954

PFO Closure, Oral Anticoagulants or Antiplatelet Therapy After PFO-associated Stroke in Patients Aged 60 to 80 Years

A Phase 3 study testing Transcatheter PFO closure, Oral Anticoagulant, Direct-Acting and Antiplatelet therapy in people with Cryptogenic Ischemic Stroke and Patent Foramen Ovale, run by Assistance Publique - Hôpitaux de Paris at 42 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

To assess whether PFO closure plus antiplatelet therapy is superior to antiplatelet therapy alone and whether oral anticoagulant therapy is superior to antiplatelet therapy to prevent stroke recurrence in patients aged 60 to 80 years with a PFO with large shunt (> 20 microbubbles) or a PFO associated with an ASA (> 10… Read more about this study

Who is it for?
Ages 60 to 80 years
What is being tested?
Transcatheter PFO closure, Oral Anticoagulant, Direct-Acting and Antiplatelet therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
792 participants
Where
42 sitesFrance
Study dates
7 Jul 2023to 7 Jul 2031
Phase
Phase 3
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 60 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Man or woman aged 60 to 80 years.
  • Recent (≤ 6 months) ischemic stroke confirmed by cerebral imaging regardless of symptom duration.
  • Absence of a more probable cause of stroke than PFO after a standardized etiological work-up (see addenda).
  • Presence of a PFO with at least 1 of the 2 following characteristics:
  • PFO with large shunt (> 20 microbubbles) appearing in the left atrium during at least one of the 3 cardiac cycles after complete opacification of the right atrium, detected either spontaneously or during provocative manoeuvers, on contrast transthoracic (TTE) or transoesophageal (TOE) echocardiography. The diagnosis of PFO by contrast TEE must be confirmed by contrast TOE showing a right-to-left passage of the contrast material across the PFO.
  • PFO associated with an ASA on transoesophageal echocardiography: excursion >10 mm
  • Affiliation to a French Health Insurance system. Informed consent.

Who cannot join

  • Life expectancy < 4 years.
  • Contraindication to both experimental treatments (PFO closure, oral anticoagulant therapy) or to the reference treatment (antiplatelet therapy) (see paragraph 20.5).
  • Indication to long-term anticoagulant therapy.
  • mRS > 3.
  • Presence of other medical conditions that would lead to inability to complete the study or interfere with the assessment of outcomes.
  • Previous surgical or transcatheter treatment of PFO or ASA. Expected impossible follow-up or poor compliance.
  • PFO associated with an atrial septal defect (ASD) requiring closure (significant shunt with impact on the right cavities, elevation of pulmonary pressures or QP/QS>2)
  • Patient unable to understand the informed consent form. Patient under tutorship, curatorship, or legal protection.

Trial locations and contacts

42 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Carla Vandenabele contact

+331 44 84 57 27

carla.vandenabele@aphp.fr

Malha Berrah contact

malha.berrah@aphp.fr

42 sites in 1 country

France42 sites, 42 recruiting

  • CHU Amiens

    Amiens, 80054

    Sandrine Canaple, MD, 03 22 66 82 40, canaple.sandrine@chu-amiens.fr

    Recruiting

  • Centre Hospitalier de la Côte Basque

    Bayonne, 64100

    Quentin BOURGEOIS-BEAUVAIS, MD, 05 59 44 37 12, qbourgeois-beauvais@ch-cotebasque.fr

    Recruiting

  • CHU Jean Minjoz

    Besançon, 25000

    Fabrice Vuillier, MD, 03 81 66 81 66, fabrice.vuillier@univ-fcomte.fr

    Recruiting

  • CHU Bordeaux - GH Pellegrin

    Bordeaux, 33000

    Pauline Renou, MD, 05 56 79 87 02, pauline.renou@chu-bordeaux.fr

    Recruiting

  • CHRU La Cavale Blanche

    Brest, 29200

    Serge Timsit, MD, 02 98 34 76 20, serge.timsit@chu-brest.fr

    Recruiting

  • HCL-Groupement Hospitalier Lyon Est

    Bron, 69677

    Laurent Derex, MD, 04 72 35 78 07, laurent.derex@chu-lyon.fr

    Recruiting

  • CHU Côte de Nacre

    Caen, 14000

    Marion Boulanger, MD, 02 31 06 46 17, boulanger-ma@chu-caen.fr

    Recruiting

  • CHU Clermont Ferrand

    Clermont-Ferrand, 63000

    Anna Ferrier, MD, 04 73 75 23 11, aferrier@chu-clermontferrand.fr

    Recruiting

  • CH Sud Francilien

    Corbeil-Essonnes, 91100

    Didier SMADJA, MD, 01 61 69 62 09, didier.smadja@chsf.fr

    Recruiting

  • Hôpital Henri Mondor

    Créteil, 94010

    Frederic Faugeras, MD, 01 49 81 23 04, frederic.faugeras@aphp.fr

    Recruiting

  • CHU Dijon-Hôpital François Mitterrand

    Dijon, 21079

    Yannick Béjot, MD, 03 80 29 37 53, yannick.bejot@chu-dijon.fr

    Recruiting

  • Hôpital Raymond Poincaré

    Garches, 92380

    Sandrine DELTOUR, MD, 01 47 10 72 34, sandrine.deltour@aphp.fr

    Recruiting

  • CH Grenoble-Site Nord

    Grenoble, 38043

    Isabelle Favre Wiki, MD, 04 76 76 57 89, ifavre@chu-grenoble.fr

    Recruiting

  • GPE Hospitalier La Rochelle-Ré-Aunis

    La Rochelle, 17000

    Gaëlle GODENECHE, MD, 05 46 45 53 12, gaelle.godeneche@ght-atlantique17.fr

    Recruiting

  • CH Versailles-Hôpital Mignot

    Le Chesnay, 78150

    Fernando Pico, MD, 01 39 63 95 17, fpico@ght78sud.fr

    Recruiting

  • CHU Bicêtre

    Le Kremlin-Bicêtre, 94370

    Christian Denier, MD, 01 45 21 38 35, christian.denier@aphp.fr

    Recruiting

  • CHRU Lille-Hôpital Salengro

    Lille, 59037

    Nelly Dequatre, MD, 03 20 44 68 14, nelly.dequatre@chru-lille.fr

    Recruiting

  • CHU Limoges - Site Dupuytren

    Limoges, 87042

    Franscisco MACIAN MONTORO, MD, 05 55 05 65 65, FRANCISCO.MACIANMONTORO@chu-limoges.fr

    Recruiting

  • Hôpital de la Timone

    Marseille, 13005

    Emmanuelle Robinet Borgomano, MD, 04 91 38 59 26, Emmanuelle.ROBINET-BORGOMANO@ap-hm.fr

    Recruiting

  • Grand Hôpital de l'Est Francilien

    Meaux, 77140

    Alain Ameri, MD, 01 64 35 38 23, aameri@ghef.fr

    Recruiting

  • Hôpital Gui de Chauliac

    Montpellier, 34295

    Caroline Arquizan, MD, 02 42 16 05 95, c-arquizan@chu-montpellier.fr

    Recruiting

  • CHU de Nice-Hôpital Pasteur

    Nice, 06000

    Marie-Hélène Mahagne, MD, 04 92 03 27 58, mahagne.mh@chu-nice.fr

    Recruiting

  • CHU Carémeau

    Nîmes, 30900

    Anne Wacongne, MD, 04 66 68 32 61, anne.wacongne@chu-nimes.fr

    Recruiting

  • CH Orsay

    Orsay, 91400

    François Lun, MD, 01 69 29 76 01, f.lun@ghne.fr

    Recruiting

  • APHP Hôpital Lariboisière

    Paris, 75010

    Peggy Reiner, MD, 01 49 95 69 51, peggy.reiner@aphp.fr

    Recruiting

  • Hôpital Pitié Salpêtrière

    Paris, 75013

    Sonia Alamowitch, MD, 01 42 16 18 54, sonia.alamowitch@aphp.fr

    Recruiting

  • GHU Paris Psychiatrie et Neurosciences

    Paris, 75014

    Guillaume Turc, MD, 01 45 65 87 94, g.turc@ghu-paris.fr

    Recruiting

  • Groupe Hospitalier Paris Saint-Joseph

    Paris, 75014

    Mathieu Zuber, MD, 01 44 12 34 09, mzuber@hpsj.fr

    Recruiting

  • Fondation Adolphe de Rothschild

    Paris, 75019

    Michaël Obadia, MD, 01 48 03 68 21, mobadia@for.paris

    Recruiting

  • CH Perpignan

    Perpignan, 66000

    Denis Sablot, MD, 04 68 61 63 39, denis.sablot@ch-perpignan.fr

    Recruiting

  • CHU La Milétrie

    Poitiers, 86021

    Nathalie Nasr, MD, 05 49 44 44 46, Nathalie.NASR@chu-poitiers.fr

    Recruiting

  • Hôpital Novo

    Pontoise, 95300

    Philippe Niclot, MD, 01 30 75 40 40, philippe.niclot@ght-novo.fr

    Recruiting

  • CHU Rennes-Hôpital Pontchaillou

    Rennes, 35000

    Stéphane Vannier, MD, 02 99 28 42 93, stephane.vannier@chu-rennes.fr

    Recruiting

  • CHU Rouen-Hôpital Charles-Nicolle

    Rouen, 76000

    Florian BASILE, MD, 06 14 15 27 05, florian.basile@chu-rouen.fr

    Recruiting

  • CH Yves Le Foll

    Saint-Brieuc, 22000

    Grégory Couvreur, MD, 02 96 01 70 77, gregory.couvreur@armorsante.bzh

    Recruiting

  • CHU Nantes-Hôpital Nord Laennec

    Saint-Herblain, 44093

    Benoit Guillon, MD, 02 40 16 52 12, benoit.guillon@chu-nantes.fr

    Recruiting

  • CHU Saint-Etienne-Hôpital Nord

    Saint-Priest-en-Jarez, 42270

    Pierre Garnier, MD, 04 77 12 78 05, pierre.garnier@chu-st-etienne.fr

    Recruiting

  • Hôpital Hautepierre

    Strasbourg, 67000

    Valérie Wolff, MD, 03 88 12 86 06, valerie.wolff@chru-strasbourg.fr

    Recruiting

  • Hôpital Foch

    Suresnes, 92150

    David WEISENBURGER-LILE, MD, 01 46 25 31 12, d.weisenburger@hopital-foch.com

    Recruiting

  • CHU Toulouse-Hôpital Pierre Paul Riquet

    Toulouse, 31059

    Nicolas Raposo, MD, 05 61 77 76 40, raposo.n@chu-toulouse.fr

    Recruiting

  • CHRU Tours- Hôpital Bretonneau

    Tours, 37000

    Marco Pasi, MD, 02 47 47 80 24, m.pasi@chu-tours.fr

    Recruiting

  • Centre Hospitalier de Valenciennes

    Valenciennes, 59300

    Olfa KAAOUANA, MD, 03 27 44 59 22, kaaouana-o@ch-valenciennes.fr

    Recruiting

Other trials in France

About this study

Official title: Transcatheter Patent Foramen Ovale (PFO) Closure, Oral Anticoagulants or Antiplatelet Therapy After PFO-associated Stroke in Patients Between 60 and 80 Years Old : a Randomised Controlled Trial.

To assess whether PFO closure plus antiplatelet therapy is superior to antiplatelet therapy alone and whether oral anticoagulant therapy is superior to antiplatelet therapy to prevent stroke recurrence in patients aged 60 to 80 years with a PFO with large shunt (> 20 microbubbles) or a PFO associated with an ASA (> 10 mm), and an otherwise unexplained ischemic stroke.

Read the detailed description

The CLOSE trial (NCT00562289, NEJM 2017) has unambiguously demonstrated the superiority of patent foramen ovale (PFO) closure over antiplatelet therapy alone in patients aged up to 60 years with a PFO associated with an atrial septal aneurysm (ASA) or a large right-to-left shunt (so-called "high-risk PFO"), and an otherwise unexplained ischemic stroke. Oral anticoagulant therapy is also a logical approach assuming that PFO-related strokes are due to paradoxical embolism which implies a venous source of embolism, or to direct embolization of a thrombus formed at the atrial level. The CLOSE trial also suggested that oral anticoagulants might reduce stroke recurrence compared to aspirin.

There is accumulating evidence that presence of a PFO is significantly associated with cryptogenic stroke in patients over 60 years. Cryptogenic ischemic strokes represent about one third of all ischemic strokes in patients older than 60 years. However, the optimal therapeutic strategy in patients older than 60 years with a PFO and an otherwise unexplained ischemic stroke is unknown, because these patients were excluded from randomized trials.

The hypothesis tested in this trial is that transcatheter PFO closure plus long-term antiplatelet therapy is superior to antiplatelet therapy alone and that oral anticoagulant therapy is superior to antiplatelet therapy to prevent recurrent stroke in patients aged 60 to 80 years who have a high-risk PFO and a recent otherwise unexplained ischemic stroke.

Being tested
Transcatheter PFO closure, Oral Anticoagulant, Direct-Acting, Antiplatelet therapy
Keywords
Ischemic stroke, Cryptogenic stroke, Patent foramen ovale, Atrial septal aneurysm, Transcatheter PFO closure, Oral anticoagulants, Antiplatelet therapy, Randomized clinical tria
Medical subject headings
Ischemic Stroke, Foramen Ovale, Patent

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcatheter PFO closureProcedure or surgery

    Also called •Each device for PFO closure must have the CE mark, •and be approved by the Interventional Cardiology Committee

    PFO closure followed by dual antiplatelet therapy (aspirin 75 mg/d + clopidogrel 75 mg/d) for 3 months, then by single antiplatelet therapy by aspirin or clopidogrel until the end of the study.

  • Oral Anticoagulant, Direct-ActingDrug

    Apixaban (5mg twice a day) OR Dabigatran (150 mg twice a day) OR Rivaroxaban (20 mg once a day)

  • Antiplatelet therapyDrug

    Patients randomized to this arm will receive antiplatelet therapy throughout the study : aspirin 75 mg/d + clopidogrel 75 mg/d) for 3 months, then single antiplatelet therapy by aspirin or clopidogrel

Study groups in NCT05387954
Study groupRoleWhat they receive
Antiplatelet therapyActive comparatorAspirin OR clopidogrel
Receives: Drug: Antiplatelet therapy
Oral anticoagulants, Direct-ActingExperimentalApixaban (5mg twice a day) OR Dabigatran (150 mg twice a day) OR Rivaroxaban (20 mg once a day)
Receives: Drug: Oral Anticoagulant, Direct-Acting
PFO closureExperimentalPFO closure followed by dual antiplatelet therapy (aspirin 75 mg/d + clopidogrel 75 mg/d) for 3 months, then by single antiplatelet therapy by aspirin or clopidogrel
Receives: Procedure: Transcatheter PFO closure; Drug: Antiplatelet therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to recurrent stroke (ischemic or hemorrhagic fatal or non-fatal)

    Stroke: sudden onset of focal neurological symptoms related to a disturbance of the cerebral circulation.

    Ischemic stroke : at least one of the following criteria:

    • Sudden onset of focal neurological symptoms with the presence of cerebral infarction in the appropriate territory on brain imaging (CT or MRI), regardless of the duration of symptoms (less than or more than 24 hours).
    • Sudden onset of focal neurological symptoms lasting more than 24 hours, with no apparent cause other than cerebral ischemia.

    Intracerebral hemorrhage: sudden onset of focal neurological symptoms with the presence of cerebral hemorrhage in the appropriate territory on brain imaging (CT or MRI), regardless of the duration of symptoms (less than or more than 24 hours) and regardless of the cause of the hemorrhage (spontaneous or secondary to trauma, tumour or another cause).

    Unknown type of stroke : the type of stroke cannot be determined with certainty and the symptoms last more than 24 hours.

    Measured: From date of randomization until the date of first recurrent stroke, assessed from up to 4 years (for the last patient included) to up to 8 years (for the first patient included)

Secondary outcomes (14)

  1. Time to disabling stroke

    mRS score greater than or equal to 3, with an increase of at least 2 points compared to the last mRS score before the stroke.

    Measured: From date of randomization until the date of first recurrent disabling stroke, assessed from up to 4 years (for the last patient included) to up to 8 years (for the first patient included)

  2. Time to ischemic stroke

    At least one of the following criteria:

    • Sudden onset of focal neurological symptoms with the presence of cerebral infarction in the appropriate territory on brain imaging (CT or MRI), regardless of the duration of symptoms (less than or more than 24 hours).
    • Sudden onset of focal neurological symptoms lasting more than 24 hours, with no apparent cause other than cerebral ischemia.

    Measured: From date of randomization until the date of first recurrent ischemic stroke, assessed from up to 4 years (for the last patient included) to up to 8 years (for the first patient included)

  3. Time to ischemic stroke or systemic embolism

    Clinical features related to embolism usually affecting a limb, mesenteric, splenic, or renal artery. The diagnosis of embolism must be confirmed by appropriate investigations.

    Measured: From date of randomization until the date of first recurrent ischemic stroke or systemic embolism, assessed from up to 4 years (for the last patient included) to up to 8 years (for the first patient included)

  4. Time to transient ischemic attack,

    Sudden onset of neurological symptoms, presumed to be ischemic, resolving in less than 24 hours, clearly attributable to focal involvement of the central nervous system (or of the eye) with no signs of a corresponding recent cerebral infarction on brain imaging. The diagnosis of TIA will be confirmed by a neurologist, considering clinical data and brain imaging (MRI with diffusion sequence is recommended).

    Measured: From date of randomization until the date of first transient ischemic attack, assessed from up to 4 years (for the last patient included) to up to 8 years (for the first patient included)

  5. Time to vascular death

    • death related to a cardiac or vascular cause.
    • death due to hemorrhage.
    • death due to pulmonary embolism.
    • sudden death: death occurring in less than 24 hours, unexpectedly in a subject in apparent good health and whose condition was stable or was improving.
    • death with no documented non-vascular cause.
    • fatal stroke: death occurring within 30 days of a stroke (ischemic or hemorrhagic).

    Measured: From date of randomization until the date of vascular death, assessed from up to 4 years (for the last patient included) to up to 8 years (for the first patient included)

  6. Time to all-cause mortality

    Vascular (see definition) or nonvascular death: death due to a documented non-vascular cause (infection, cancer, accident, suicide, etc.).

    Measured: From date of randomization until the date of death, assessed from up to 4 years (for the last patient included) to up to 8 years (for the first patient included)

  7. Quality of life score

    Measured by using the European Quality Of Life (EQ-5D) auto-questionnaire. The digits for the five dimensions are combined into a 5-digit number that describes the patient's health state. The visual analogue scale (VAS) records the patient's self-rated health on a vertical axis from 0 (worst health) to 100 (best health)

    Measured: Every 6 months after randomization or up to 4 years (for the last patient included) to up to 8 years (for the first patient included)]

  8. Time to fatal, life-threatening or major hemorrhage, including intracerebral and Intracranial hemorrhage

    Life-threatening

    • Fatal hemorrhage.
    • Drop in hemoglobin by ≥ 5 g/dL (or drop in hematocrit by 15% or more in absolute value)
    • Symptomatic intracranial hemorrhage (confirmed by appropriate investigations, classified as cerebral hemorrhage, subarachnoid hemorrhage and subdural hematoma).
    • Transfusion ≥ 4 units of packed cells (or equivalent of whole blood)*.

    Major

    • Transfusion ≤ 3 units of packed cells (or equivalent of whole blood)*.
    • Requiring hospitalization (or prolonging hospitalization).
    • Requiring surgical treatment.
    • Intraocular hemorrhage with significant loss of vision.
    • Other hemorrhage responsible for significant disability according to the investigator.

    Measured: From date of randomization until the date of first fatal,life-threatening or major hemorrhage,including intracerebral and Intracranial hemorrhage,assessed from up to 4 years(for the last patient included) to up to 8 years(for the first patient included)

  9. Proportion of success of device implantation, of the procedure and of PFO closure,

    • Success of device implantation: deployment of the device in the appropriate place and removal of the placement system.
    • Success of the procedure: successful implantation with no complications before the patient's discharge.
    • Success of PFO closure: success of the procedure with no residual shunt or minimal residual shunt on echocardiography performed 6 months after the procedure.

    Measured: 6 months after PFO closure

  10. Time to ischemic stroke recurrence according to the presence of a residual shunt

    From control echocardiography after PFO closure to the end of the patient's follow-up

    Measured: From date of PFO closure until the date of first ischemic stroke recurrence, assessed from up to 4 years (for the last patient included) to up to 8 years (for the first patient included), according to the presence of residual shunt]

  11. Time to new-onset atrial fibrillation

    Atrial fibrillation lasting at least 30 seconds

    Measured: From date of randomization until the date of new-onset atrial fibrillation, assessed from up to 4 years (for the last patient included) to up to 8 years (for the first patient included)]

  12. Proportion of fatal, life-threatening or major procedure- or device-related complications

    Life-threatening

    • Cardiac perforation with tamponade requiring emergency drainage.
    • Cerebral air embolism responsible for acute neurological disorders
    • Embolization of the device.
    • Life-threatening hematoma at the puncture site or retroperitoneal.
    • Complications of general anesthesia or TOE requiring intensive care and/or surgical operation.

    Major

    • Hemorrhage at the puncture site or retroperitoneal requiring transfusion or surgery.
    • Arteriovenous fistula, pseudoaneurysm requiring surgery.
    • Peripheral nerve lesion with disabling neurological deficit persisting > 1 month.
    • Cardiac arrhythmias (particularly AF) during catheterization or post-procedure requiring treatment >= 1 month.
    • Infective endocarditis.
    • Asymptomatic late thrombosis of the device.
    • Any device-related complication requiring surgery.
    • Any other complication related to the transcatheter treatment or anesthesia, considered to be major by the investigator.

    Measured: Within 4 weeks following the procedure (PFO closure)

  13. Costs

    Costs will be estimated from the viewpoint of the healthcare system (hospital admission, transportation, study interventions, emergency room visit without admission,consultations,imaging)

    Measured: Within 48 months after randomization

  14. Incremental cost-utility ratio at 4 years (ICUR)

    The incremental cost-utility ratio (ICUR) will be calculated as difference in costs (between groups)/difference in QALYs (Quality-Adjusted Life Year) between groups.

    The QALYs will be constructed with the EuroQoL-5D (EQ-5D) questionnaire and value sets

    Measured: Within 48 months after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2022
  2. Study start7 Jul 2023
  3. Primary completion7 Jul 2031 (estimated)
  4. Study completion7 Jul 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
PFO closure + antiplatelet therapy versus antiplatelet therapy alone Oral anticoagulants versus antiplatelet therapy
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
792 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05387954
Sponsor's protocol ID
APHP211041
Other IDs
2021-A03197-34, PHRC-20-0680
Acronym
CLOSE-2
Status last verified
Mar 2026
First submitted
4 May 2022
Last updated
24 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Transcatheter PFO closure, Oral Anticoagulant, Direct-Acting and Antiplatelet therapy in people with Cryptogenic Ischemic Stroke and Patent Foramen Ovale, run by Assistance Publique - Hôpitaux de Paris at 42 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 7 inclusion and 8 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 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Carla Vandenabele (+331 44 84 57 27, carla.vandenabele@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to recurrent stroke (ischemic or hemorrhagic fatal or non-fatal) (time frame: From date of randomization until the date of first recurrent stroke, assessed from up to 4 years (for the last patient included) to up to 8 years (for the first patient included)). 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 NCT05387954.

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 24 Mar 2026.

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