Clinical trial • Not applicable • Neurology
apixaban for Intracerebral haemorrhage|Atrial fibrillation
Not applicable trial of apixaban for Intracerebral haemorrhage|Atrial fibrillation.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Intracerebral haemorrhage|Atrial fibrillation
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 27-09-2024
- First CTIS Authorization Date
- 24-10-2024
Trial design
Randomised, three strategies compared: direct oac (direct oral anticoagulant — apixaban (eliquis 2.5 mg film-coated tablets) is listed among medicinal products), left atrial appendage closure (laac) using devices (e.g. watchman, amplatzer_cardiac_plug as referenced in documents), and usual care (avoiding anticoagulation and laac). dose/schedule not specified in trial documents provided.-controlled Not applicable trial in France.
- Randomised
- Yes
- Comparator
- Three strategies compared: Direct OAC (direct oral anticoagulant — apixaban (Eliquis 2.5 mg film-coated tablets) is listed among medicinal products), Left Atrial Appendage Closure (LAAC) using devices (e.g. WATCHMAN, AMPLATZER_CARDIAC_PLUG as referenced in documents), and usual care (avoiding anticoagulation and LAAC). Dose/schedule not specified in trial documents provided.
- Target Sample Size
- 300
- Trial Duration For Participant
- 730
Eligibility
Recruits 300 People under guardianship, trusteeship, deprived of freedom are explicitly excluded. The trial enrols adults only (older than 18). Subject information and informed consent forms for patient and caregiver are listed in trial documents (L1_ICF_patient, L1_ICF_caregiver), indicating consent is provided by the adult participant; caregiver information/consent documents are available..
- Pregnancy Exclusion
- Pregnancy or breastfeeding
- Vulnerable Population
- People under guardianship, trusteeship, deprived of freedom are explicitly excluded. The trial enrols adults only (older than 18). Subject information and informed consent forms for patient and caregiver are listed in trial documents (L1_ICF_patient, L1_ICF_caregiver), indicating consent is provided by the adult participant; caregiver information/consent documents are available.
Inclusion criteria
- {"criterion_text":"- Adult (older than 18 years old, no upper age limit)"}
- {"criterion_text":"- With a history of paroxysmal, persistent or long-standin g non-valvular atrial fibrillation (documented on an electrocardiogram)"}
- {"criterion_text":"- And a CHA2DS2VASc (22) score of 2 or more who have an indication for long-term anticoagulation"}
- {"criterion_text":"- Who suffered from a spontaneous intracerebral haemorrhage (while being treated with oral anticoagulants or not) documented with brain CT or MRI"}
- {"criterion_text":"- More than 1 month (more precisely 30 days) before randomization (no upper delay limit)"}
- {"criterion_text":"- For whom there is a clinical equipoise regarding the choice of the best preventive strategy to avoid future vascular events."}
- {"criterion_text":"- Being affiliated to the Sécurité Sociale"}
Exclusion criteria
- {"criterion_text":"- Severe chronic renal insufficiency (clearance of creatinine < 15ml/min)"}
- {"criterion_text":"- Pre-randomisation modified Rankin (2) score of 4 or 5"}
- {"criterion_text":"- Conditions other than atrial fibrillation for which the patient requires long term anticoagulation (for example prosthetic mechanical heart valve)"}
- {"criterion_text":"- Serious bleeding events within the 6 months before randomisation (except for intracerebral haemorrhage)"}
- {"criterion_text":"- Life expectancy of less than 1 year"}
- {"criterion_text":"- Pregnancy or breastfeeding"}
- {"criterion_text":"- Woman of childbearing age not taking effective contraception"}
- {"criterion_text":"- People under guardianship, trusteeship, deprive of freedom"}
- {"criterion_text":"- Any other contraindication according to the health care team"}
- {"criterion_text":"- (Exclusion criteria related to the LAAC only): Contraindications due to local, anatomical reasons (such as thrombus in the left atrial appendage, infection with a risk of endocarditis)"}
- {"criterion_text":"- (Exclusion criteria related to the LAAC only): Patients older than 85 years"}
- {"criterion_text":"- (Exclusion criteria related to the LAAC only): CHA2DS2VASc score of 2 or 3"}
- {"criterion_text":"- (Exclusion criteria related to the LAAC only): Any other contraindication according to the health care team"}
- {"criterion_text":"- (Exclusion criteria related to the Direct OAC only): Allergy to apixaban"}
- {"criterion_text":"- (Exclusion criteria related to the Direct OAC only): Coexisting conditions predisposing to head trauma (e.g. gait disturbances, uncontrolled seizures disorders)"}
- {"criterion_text":"- (Exclusion criteria related to the Direct OAC only): Any other contraindication according to the health care team"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary endpoint is a composite criterion including all fatal or lifethreatening and major vascular events, i.e. cardiovascular/cerebrovascular ischaemic or haemorrhagic intracranial/extracranial events within 24 months after randomization","definition_or_measurement_approach":"Composite of all fatal or life‑threatening and major vascular events (cardiovascular/cerebrovascular ischaemic or haemorrhagic intracranial/extracranial events) assessed within 24 months after randomization."}
Secondary endpoints
- {"endpoint_text":"- Each individual component of the composite outcome at 24 month after randomization (fatal or non-fatal major vascular events, i.e. cardiovascular/cerebrovascular ischaemic or haemorrhagic intracranial/extracranial events)","definition_or_measurement_approach":"Each component of the composite outcome assessed at 24 months after randomization (fatal or non-fatal major vascular events)."}
- {"endpoint_text":"- Death of any cause at 24 months after randomization","definition_or_measurement_approach":"All-cause mortality measured at 24 months after randomization."}
- {"endpoint_text":"- Functional dependence scored on the modified Rankin Scale at 24 months after randomization in a shift analysis","definition_or_measurement_approach":"Modified Rankin Scale score at 24 months; analyzed as shift in distribution."}
- {"endpoint_text":"- Health-related quality of life measured by the EQ-5D (EuroQoL) at 24 months after randomization","definition_or_measurement_approach":"EQ-5D (EuroQoL) assessment at 24 months after randomization."}
- {"endpoint_text":"- Baseline small-vessel diseases biomarkers on brain MRI (brain microbleeds, leukoaraiosis, superficial siderosis, perivascular spaces, territorial infarcts, silent macrohaemorrhages, cortical atrophy)","definition_or_measurement_approach":"Baseline brain MRI biomarkers assessment (listing of small-vessel disease features) to describe/predict risk."}
- {"endpoint_text":"- Complications of endovascular treatment (up to 30 days)","definition_or_measurement_approach":"Procedural complications captured up to 30 days post-procedure."}
- {"endpoint_text":"- Overall evaluation of the success of the procedure (at 30 days)","definition_or_measurement_approach":"Overall procedural success assessed at 30 days."}
Recruitment
- Planned Sample Size
- 300
- Recruitment Window Months
- 133
- Consent Approach
- Informed consent obtained from adult participants (study includes adults only). Subject information and informed consent forms for patients and caregivers are listed in the trial documents (L1_ICF_patient, L1_ICF_caregiver, L1_ICF_patient FU). Documents include French translations of titles; explicit languages available beyond French are not specified in the provided data.
Geography
- Total Number Of Sites
- 36
- Total Number Of Participants
- 300
France
- Earliest CTIS Part Ii Submission Date
- 14-10-2024
- Latest Decision Or Authorization Date
- 30-03-2026
- Processing Time Days
- 532
- Number Of Sites
- 36
- Number Of Participants
- 300
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Neurology
- Principal Investigator Name
- Christian Denier
- Principal Investigator Email
- christian.denier@aphp.fr
- Contact Person Name
- Christian Denier
- Contact Person Email
- christian.denier@aphp.fr
- Site Name
- Centre Hospitalier Universitaire Grenoble Alpes
- Department Name
- Neurology
- Principal Investigator Name
- Olivier Detante
- Principal Investigator Email
- odetante@chu-grenoble.fr
- Contact Person Name
- Olivier Detante
- Contact Person Email
- odetante@chu-grenoble.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Neurology
- Principal Investigator Name
- Eric Jouvent
- Principal Investigator Email
- eric.jouvent@aphp.fr
- Contact Person Name
- Eric Jouvent
- Contact Person Email
- eric.jouvent@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Neurology
- Principal Investigator Name
- Aymeric WITTWER
- Principal Investigator Email
- aymeric.wittwer@aphp.fr
- Contact Person Name
- Aymeric WITTWER
- Contact Person Email
- aymeric.wittwer@aphp.fr
- Site Name
- Hospital Foch
- Department Name
- Neurology
- Principal Investigator Name
- David Weisenburger-Lile
- Principal Investigator Email
- d.weisenburger@hopital-foch.com
- Contact Person Name
- David Weisenburger-Lile
- Contact Person Email
- d.weisenburger@hopital-foch.com
- Site Name
- Centre Hospitalier Universitaire Amiens Picardie
- Department Name
- Neurology
- Principal Investigator Name
- Sandrine Canaple
- Principal Investigator Email
- Canaple.Sandrine@chu-amiens.fr
- Contact Person Name
- Sandrine Canaple
- Contact Person Email
- Canaple.Sandrine@chu-amiens.fr
- Site Name
- Groupement Des Hopitaux De L'Institut Catholique De Lille
- Department Name
- Neurology
- Principal Investigator Name
- Marta Pasquini
- Principal Investigator Email
- pasquini.marta@ghicl.net
- Contact Person Name
- Marta Pasquini
- Contact Person Email
- pasquini.marta@ghicl.net
- Site Name
- Centre Hospitalier Universitaire D'Angers
- Department Name
- Neurology
- Principal Investigator Name
- Sophie Godard
- Principal Investigator Email
- SoGodard@chu-angers.fr
- Contact Person Name
- Sophie Godard
- Contact Person Email
- SoGodard@chu-angers.fr
- Site Name
- Fondation A De Rothschild
- Department Name
- Neurology
- Principal Investigator Name
- Michael Obadia
- Principal Investigator Email
- mobadia@for.paris
- Contact Person Name
- Michael Obadia
- Contact Person Email
- mobadia@for.paris
- Site Name
- Centre Hospitalier Sud Francilien
- Department Name
- Neurology
- Principal Investigator Name
- Yann L'Hermitte
- Principal Investigator Email
- yann.lhermitte@chsf.fr
- Contact Person Name
- Yann L'Hermitte
- Contact Person Email
- yann.lhermitte@chsf.fr
- Site Name
- Centre Hospitalier Regional Et Universitaire De Brest
- Department Name
- Neurology
- Principal Investigator Name
- Serge Timsit
- Principal Investigator Email
- serge.timsit@chu-brest.fr
- Contact Person Name
- Serge Timsit
- Contact Person Email
- serge.timsit@chu-brest.fr
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- Neurology
- Principal Investigator Name
- Barbara Casolla
- Principal Investigator Email
- casolla.b@chu-nice.fr
- Contact Person Name
- Barbara Casolla
- Contact Person Email
- casolla.b@chu-nice.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Service de neurologie, Unité Neurovasculaire
- Principal Investigator Name
- Lucas Corti
- Principal Investigator Email
- l-corti@chu-montpellier.fr
- Contact Person Name
- Lucas Corti
- Contact Person Email
- l-corti@chu-montpellier.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Service de neurologie vasculaire
- Principal Investigator Name
- Elodie Ong
- Principal Investigator Email
- elodie.ong@chu-lyon.fr
- Contact Person Name
- Elodie Ong
- Contact Person Email
- elodie.ong@chu-lyon.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Unité Neuro-vasculaire
- Principal Investigator Name
- Igor Sibon
- Principal Investigator Email
- igor.sibon@chu-bordeaux.fr
- Contact Person Name
- Igor Sibon
- Contact Person Email
- igor.sibon@chu-bordeaux.fr
- Site Name
- Centre Hospitalier Universitaire De Caen Normandie
- Department Name
- Neurologt
- Principal Investigator Name
- Emmanuel Touze
- Principal Investigator Email
- touze-e@chu-caen.fr
- Contact Person Name
- Emmanuel Touze
- Contact Person Email
- touze-e@chu-caen.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Neurologie et Unité NeuroVasculaire
- Principal Investigator Name
- Emmanuelle Robinet-Borgomano
- Principal Investigator Email
- Emmanuelle.ROBINET-BORGOMANO@ap-hm.fr
- Contact Person Name
- Emmanuelle Robinet-Borgomano
- Contact Person Email
- Emmanuelle.ROBINET-BORGOMANO@ap-hm.fr
- Site Name
- University Hospital Of Clermont-Ferrand
- Department Name
- Unité neurovasculaire
- Principal Investigator Name
- Anne Ferrier
- Principal Investigator Email
- aferrier@chu-clermontferrand.fr
- Contact Person Name
- Anne Ferrier
- Contact Person Email
- aferrier@chu-clermontferrand.fr
- Site Name
- Groupe Hospitalier Bretagne Sud
- Department Name
- Neurology
- Principal Investigator Name
- Claire Tourtier-Bellosta
- Principal Investigator Email
- c.tourtierbellosta@ghbs.bzh
- Contact Person Name
- Claire Tourtier-Bellosta
- Contact Person Email
- c.tourtierbellosta@ghbs.bzh
- Site Name
- Centre Hospitalier Universitaire De Rennes
- Department Name
- Neurology
- Principal Investigator Name
- Stéphane Vannier
- Principal Investigator Email
- stephane.vannier@chu-rennes.fr
- Contact Person Name
- Stéphane Vannier
- Contact Person Email
- stephane.vannier@chu-rennes.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Neurology
- Principal Investigator Name
- Valérie Wolff
- Principal Investigator Email
- valerie.wolff@chru-strasbourg.fr
- Contact Person Name
- Valérie Wolff
- Contact Person Email
- valerie.wolff@chru-strasbourg.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Neurology
- Principal Investigator Name
- Nicolas Raposo
- Principal Investigator Email
- raposo.n@chu-toulouse.fr
- Contact Person Name
- Nicolas Raposo
- Contact Person Email
- raposo.n@chu-toulouse.fr
- Site Name
- GIE Groupe hospitalier Paris Saint-Joseph/Vinci
- Department Name
- Neurology
- Principal Investigator Name
- Mathieu Zuber
- Principal Investigator Email
- mzuber@hpsj.fr
- Contact Person Name
- Mathieu Zuber
- Contact Person Email
- mzuber@hpsj.fr
- Site Name
- Centre Hospitalier Universitaire Reims
- Department Name
- Neurology
- Principal Investigator Name
- Solène Moulin
- Principal Investigator Email
- smoulin@chu-reims.fr
- Contact Person Name
- Solène Moulin
- Contact Person Email
- smoulin@chu-reims.fr
- Site Name
- Centre Hospitalier De Versailles
- Department Name
- Neurology
- Principal Investigator Name
- Fernando Pico
- Principal Investigator Email
- fpico@ch-versailles.fr
- Contact Person Name
- Fernando Pico
- Contact Person Email
- fpico@ch-versailles.fr
- Site Name
- CHRU De Nancy
- Department Name
- Neurology
- Principal Investigator Name
- Vincent Richard
- Principal Investigator Email
- s.richard@chru-nancy.fr
- Contact Person Name
- Vincent Richard
- Contact Person Email
- s.richard@chru-nancy.fr
- Site Name
- Centre Hospitalier Saint Nazaire
- Department Name
- Neurology
- Principal Investigator Name
- Pierre Agius
- Principal Investigator Email
- p.agius@ch-saintnazaire.fr
- Contact Person Name
- Pierre Agius
- Contact Person Email
- p.agius@ch-saintnazaire.fr
- Site Name
- Centre Hospitalier Et Universitaire De Limoges
- Department Name
- Neurology
- Principal Investigator Name
- Francisco Macian Montoro
- Principal Investigator Email
- Francisco.Macian-Montoro@chu-limoges.fr
- Contact Person Name
- Francisco Macian Montoro
- Contact Person Email
- Francisco.Macian-Montoro@chu-limoges.fr
- Site Name
- Centre Hospitalier De Tourcoing
- Department Name
- Neurology
- Principal Investigator Name
- Sophie Delalande
- Principal Investigator Email
- sdelalande@ch-tourcoing.fr
- Contact Person Name
- Sophie Delalande
- Contact Person Email
- sdelalande@ch-tourcoing.fr
- Site Name
- Groupe Hospitalier Universitaire Paris Psychiatrie Et Neuroscience
- Department Name
- Neurology
- Principal Investigator Name
- David Calvet
- Principal Investigator Email
- D.CALVET@ghu-paris.fr
- Contact Person Name
- David Calvet
- Contact Person Email
- D.CALVET@ghu-paris.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Neurology
- Principal Investigator Name
- Charlotte Cordonnier
- Principal Investigator Email
- charlotte.cordonnier@chru-lille.fr
- Contact Person Name
- Charlotte Cordonnier
- Contact Person Email
- charlotte.cordonnier@chru-lille.fr
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- Neurology
- Principal Investigator Name
- Matthias Lamy
- Principal Investigator Email
- Matthias.LAMY@chu-poitiers.fr
- Contact Person Name
- Matthias Lamy
- Contact Person Email
- Matthias.LAMY@chu-poitiers.fr
- Site Name
- Centre Hospitalier Universitaire De Saint Etienne
- Department Name
- Unité Neurovasculaire
- Principal Investigator Name
- Pierre Garnier
- Principal Investigator Email
- pierre.garnier@chu-st-etienne.fr
- Contact Person Name
- Pierre Garnier
- Contact Person Email
- pierre.garnier@chu-st-etienne.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service de neurologie et d'urgence Neurovasculaire
- Principal Investigator Name
- Sonia Alamowitch
- Principal Investigator Email
- sonia.alamowitch@aphp.fr
- Contact Person Name
- Sonia Alamowitch
- Contact Person Email
- sonia.alamowitch@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Neurology
- Principal Investigator Name
- Benoit Guillon
- Principal Investigator Email
- benoit.guillon@chu-nantes.fr
- Contact Person Name
- Benoit Guillon
- Contact Person Email
- benoit.guillon@chu-nantes.fr
- Site Name
- Centre Hospitalier Regional Universitaire De Tours
- Department Name
- Neurology
- Principal Investigator Name
- Marco Pasi
- Principal Investigator Email
- m.pasi@chu-tours.fr
- Contact Person Name
- Marco Pasi
- Contact Person Email
- m.pasi@chu-tours.fr
Sponsor
Primary sponsor
- Full Name
- Centre Hospitalier Universitaire De Lille
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- Eliquis 2.5 mg film-coated tablets
- Active Substance
- apixaban
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Authorisation Status
- Authorised (EU marketing authorisation EU/1/11/691/013)
- Maximum Dose
- 10 mg
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