Clinical trial • Phase III • Cardiology|Neurology
Alteplase for Acute ischemic stroke (anterior circulation large vessel occlusion)
Phase III trial of Alteplase for Acute ischemic stroke (anterior circulation large vessel occlusion).
Overview
- Trial Therapeutic Area
- Cardiology|Neurology
- Trial Disease
- Acute ischemic stroke (anterior circulation large vessel occlusion)
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 01-06-2024
- First CTIS Authorization Date
- 12-09-2024
Trial design
Randomised, open-label, control group: no ia thrombolysis after ivt alone, bridging therapy (ivt + mt), or mt alone (according to standard of care). experimental group: adjunct ia thrombolysis after ivt alone, bridging therapy (ivt + mt), or mt alone. Phase III trial across 27 sites in France.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Control group: no IA thrombolysis after IVT alone, bridging therapy (IVT + MT), or MT alone (according to standard of care). Experimental group: adjunct IA thrombolysis after IVT alone, bridging therapy (IVT + MT), or MT alone.
- Target Sample Size
- 626
- Trial Duration For Participant
- 365
Eligibility
Recruits 626 Vulnerable population selected (isVulnerablePopulationSelected = true). Subject information and informed consent forms available for Patient (Initial and Continuation) and for 'Proche' (relative/proxy), indicating provisions for proxy/relative involvement in consent..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected = true). Subject information and informed consent forms available for Patient (Initial and Continuation) and for 'Proche' (relative/proxy), indicating provisions for proxy/relative involvement in consent.
Inclusion criteria
- {"criterion_text":"- Pre-stroke mRS 0-2\n- Acute ischemic stroke with anterior circulation LVO defined as intracranial internal carotid artery, M1, or M2 occlusion proven on CT or MRI\n- NIHSS score ≥ 5 at admission\n- eTICI 2b-2c-3 after IVT alone, bridging therapy (IVT + MT), or MT alone and confirmed by catheter angiogram"}
Exclusion criteria
- {"criterion_text":"- Contraindications for IA thrombolysis: Platelet count <100 000/mm3, INR >1.7, AOD use <48h or biological confirmation of activity and effective heparin treatment\n- Intracerebral hemorrhage\n- Occlusion or high grade stenosis treated by stenting\n- Patient expected to be unable to present or be available for 3-month visit follow-up"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary endpoint is the severity of disability according to the shift of scores on the modified Rankin Scale (mRS) at 90 (±15) days.","definition_or_measurement_approach":"Shift in modified Rankin Scale (mRS) score measured at 90 days (±15 days)."}
Secondary endpoints
- {"endpoint_text":"- 1a) EFFICACY: -Distribution of the mRS score at day 90 (±15).","definition_or_measurement_approach":"Distribution of mRS scores at day 90 (±15 days)."}
- {"endpoint_text":"- 1a) EFFICACY: -Excellent functional outcome (mRS 0-1) at 90 (±15) day.","definition_or_measurement_approach":"Proportion of participants with mRS 0-1 at 90 (±15 days)."}
- {"endpoint_text":"- 1a) EFFICACY: -Functional independence (mRS 0-2) at 90 (±15) day.","definition_or_measurement_approach":"Proportion of participants with mRS 0-2 at 90 (±15 days)."}
- {"endpoint_text":"- 1a) EFFICACY: -Early neurological improvement (reduction in National Institutes of Health Stroke Scale (NIHSS) score by at least 8 points, or NIHSS score of 0-1) at 24 (±6) hours.","definition_or_measurement_approach":"Change in NIHSS at 24 (±6) hours: reduction ≥8 points or NIHSS 0-1."}
- {"endpoint_text":"- 1a) EFFICACY: -eTICI at the end of endovascular procedure (including IA thrombolysis in the intervention group).","definition_or_measurement_approach":"eTICI grade assessed at the end of the endovascular procedure."}
- {"endpoint_text":"- 1a) EFFICACY: -Infarct growth: difference in (i) ASPECTS scores and (ii) infarct core volume (MRI DWI or CT perfusion) between 24 (±6) hours and baseline","definition_or_measurement_approach":"Difference in ASPECTS and infarct core volume (MRI DWI or CT perfusion) between baseline and 24 (±6) hours."}
- {"endpoint_text":"- 1b) SAFETY: -Complications during endovascular treatment: arterial perforation, extracranial carotid dissection, embolization in a new territory.","definition_or_measurement_approach":"Occurrence of listed procedural complications during endovascular treatment."}
- {"endpoint_text":"- 1b) SAFETY: -Symptomatic and asymptomatic intracerebral hemorrhage within 24-hour on CT or MRI, according to the Heidelberg classification (imaging core laboratory).","definition_or_measurement_approach":"Intracerebral hemorrhage within 24 hours assessed by CT/MRI and classified per Heidelberg classification (central imaging core lab review)."}
- {"endpoint_text":"- 1b) SAFETY: -Extracranial hemorrhage requiring transfusion, surgery or resulting in death","definition_or_measurement_approach":"Occurrence of extracranial hemorrhage requiring transfusion, surgery, or resulting in death."}
- {"endpoint_text":"- 1b) SAFETY: -Death from all causes within 90 (±15) days","definition_or_measurement_approach":"All-cause mortality within 90 (±15) days."}
- {"endpoint_text":"- 2) COST EFFECTIVENESS: Incremental cost-effectiveness and cost-utility ratios of a strategy based on adjunct IA thrombolysis in case of successful angiographic reperfusion compared with a strategy of no adjunct IA thrombolysis.","definition_or_measurement_approach":"Economic evaluation calculating incremental cost-effectiveness and cost-utility ratios comparing strategies with and without adjunct IA thrombolysis."}
- {"endpoint_text":"- 3) TOTAL COST: Total cost of each treatment strategy and net impact on the National Health Insurance System (difference in costs).","definition_or_measurement_approach":"Total cost per treatment strategy and difference in costs (budget impact) on the National Health Insurance System."}
Recruitment
- Planned Sample Size
- 626
- Recruitment Window Months
- 48
- Consent Approach
- Subject information and informed consent forms provided for Patient (Initial and Continuation) and for 'Proche' (relative/proxy). Consent documents available as L1_ICF_Patient_Initial, L1_ICF_Patient_Poursuite, L1_ICF_Proche_Initial, L1_ICF_Proche_Poursuite and related information sheets; indicates consent from patient or proxy/relative where applicable. No explicit age-specific assent documents or languages stated in the record.
Geography
- Total Number Of Sites
- 27
- Total Number Of Participants
- 626
France
- Earliest CTIS Part Ii Submission Date
- 03-09-2024
- Latest Decision Or Authorization Date
- 16-04-2025
- Processing Time Days
- 225
- Number Of Sites
- 27
- Number Of Participants
- 626
Sites
- Site Name
- Besancon University Hospital Center
- Department Name
- Neuroradiologie Interventionnelle
- Principal Investigator Name
- Guillaume CHARBONNIER
- Principal Investigator Email
- Guillaume.charbonnier@univ-fcomte.fr
- Contact Person Name
- Guillaume CHARBONNIER
- Contact Person Email
- Guillaume.charbonnier@univ-fcomte.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Neuroradiologie diagnostique et thérapeutique
- Principal Investigator Name
- Anne-Christine JANUEL
- Principal Investigator Email
- Januel.ac@chu-toulouse.fr
- Contact Person Name
- Anne-Christine JANUEL
- Contact Person Email
- Januel.ac@chu-toulouse.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Neuroradiologie Diagnostique et Thérapeutique
- Principal Investigator Name
- Cyril DARGAZANLI
- Principal Investigator Email
- c-dargazanli@chu-montpellier.fr
- Contact Person Name
- Cyril DARGAZANLI
- Contact Person Email
- c-dargazanli@chu-montpellier.fr
- Site Name
- Centre Hospitalier De La Cote Basque
- Department Name
- Radiology Diagnostique
- Principal Investigator Name
- Louis VEUNAC
- Principal Investigator Email
- lveunac@ch-cotebasque.fr
- Contact Person Name
- Louis VEUNAC
- Contact Person Email
- lveunac@ch-cotebasque.fr
- Site Name
- University Hospital Of Clermont-Ferrand
- Department Name
- Neuroradiologie Diagnostique et Interventionnelle
- Principal Investigator Name
- Emmanuel CHABERT
- Principal Investigator Email
- echabert@chu-clermontferrand.fr
- Contact Person Name
- Emmanuel CHABERT
- Contact Person Email
- echabert@chu-clermontferrand.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Neuroradiologie Interventionnelle
- Principal Investigator Name
- Frédéric CLARENCON
- Principal Investigator Email
- frederic.clarencon@aphp.fr
- Contact Person Name
- Frédéric CLARENCON
- Contact Person Email
- frederic.clarencon@aphp.fr
- Site Name
- HIA Sainte Anne
- Department Name
- Neuroradiologie Interventionnelle
- Principal Investigator Name
- Quentin HOLAY
- Principal Investigator Email
- qholay@gmail.com
- Contact Person Name
- Quentin HOLAY
- Contact Person Email
- qholay@gmail.com
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- Neuroradiologie Interventionnelle
- Principal Investigator Name
- Victor DUMAS
- Principal Investigator Email
- Victor.dumas@chu-poitiers.fr
- Contact Person Name
- Victor DUMAS
- Contact Person Email
- Victor.dumas@chu-poitiers.fr
- Site Name
- Centre Hospitalier Universitaire Amiens Picardie
- Department Name
- Radiologie interventionnelle
- Principal Investigator Name
- Cyril CHIVOT
- Principal Investigator Email
- Chivot.Cyril@chu-amiens.fr
- Contact Person Name
- Cyril CHIVOT
- Contact Person Email
- Chivot.Cyril@chu-amiens.fr
- Site Name
- Bicetre Hospital
- Department Name
- Neuroradiologie Interventionnelle
- Principal Investigator Name
- Jildaz CAROFF
- Principal Investigator Email
- jildaz.caroff@gmail.com
- Contact Person Name
- Jildaz CAROFF
- Contact Person Email
- jildaz.caroff@gmail.com
- Site Name
- CHU De Rouen
- Department Name
- Neuroradiologie diagnostique et Interventionnelle
- Principal Investigator Name
- Chrisanthi PAPAGIANNAKI
- Principal Investigator Email
- c.papagiannaki@chu-rouen.fr
- Contact Person Name
- Chrisanthi PAPAGIANNAKI
- Contact Person Email
- c.papagiannaki@chu-rouen.fr
- Site Name
- Hospital Foch
- Department Name
- Neuroradiologie Interventionnelle
- Principal Investigator Name
- Arturo CONSOLI
- Principal Investigator Email
- a.consoli@hopital-foch.com
- Contact Person Name
- Arturo CONSOLI
- Contact Person Email
- a.consoli@hopital-foch.com
- Site Name
- Centre Hospitalier Universitaire Grenoble Alpes
- Department Name
- Neuroradiologie
- Principal Investigator Name
- Olivier HECK
- Principal Investigator Email
- oheck@chu-grenoble.fr
- Contact Person Name
- Olivier HECK
- Contact Person Email
- oheck@chu-grenoble.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Neuroradiologie Interventionnelle et Diagnostique
- Principal Investigator Name
- Gaultier MARNAT
- Principal Investigator Email
- gaultier.marnat@chu-bordeaux.fr
- Contact Person Name
- Gaultier MARNAT
- Contact Person Email
- gaultier.marnat@chu-bordeaux.fr
- Site Name
- Assistance Publique Hopitaux De Paris (site 2)
- Department Name
- Neuroradiologie
- Principal Investigator Name
- Marc-Antoine LABEYRIE
- Principal Investigator Email
- marc-antoine.labeyrie@aphp.fr
- Contact Person Name
- Marc-Antoine LABEYRIE
- Contact Person Email
- marc-antoine.labeyrie@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Caen Normandie
- Department Name
- Radiologie
- Principal Investigator Name
- Charlotte BARBIER
- Principal Investigator Email
- barbier-ch@chu-caen.fr
- Contact Person Name
- Charlotte BARBIER
- Contact Person Email
- barbier-ch@chu-caen.fr
- Site Name
- Hopital Fondation Adolphe De Rothschild
- Department Name
- Neuroradiologie Interventionnelle
- Principal Investigator Name
- Jean-Philippe DESILLES
- Principal Investigator Email
- jpdesilles@for.paris
- Contact Person Name
- Jean-Philippe DESILLES
- Contact Person Email
- jpdesilles@for.paris
- Site Name
- Centre Hospitalier Regional Et Universitaire De Brest
- Department Name
- Radiologie
- Principal Investigator Name
- Jean-Christophe GENTRIC
- Principal Investigator Email
- jcgentric.nri.brest@chu-brest.fr
- Contact Person Name
- Jean-Christophe GENTRIC
- Contact Person Email
- jcgentric.nri.brest@chu-brest.fr
- Site Name
- Centre Hospitalier Sainte Anne Paris
- Department Name
- Neuroradiologie Interventionnelle
- Principal Investigator Name
- Olivier NAGGARA
- Principal Investigator Email
- O.NAGGARA@ghu-paris.fr
- Contact Person Name
- Olivier NAGGARA
- Contact Person Email
- O.NAGGARA@ghu-paris.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Neurologie
- Principal Investigator Name
- Pacôme CONSTANT DIT BEAUFILS
- Principal Investigator Email
- pacome.constantditbeaufils@chu-nantes.fr
- Contact Person Name
- Pacôme CONSTANT DIT BEAUFILS
- Contact Person Email
- pacome.constantditbeaufils@chu-nantes.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Neuroradiologie diagnostique et Interventionnelle
- Principal Investigator Name
- Martin BRETZNER
- Principal Investigator Email
- martin.bretzner@chu-lille.fr
- Contact Person Name
- Martin BRETZNER
- Contact Person Email
- martin.bretzner@chu-lille.fr
- Site Name
- Centre Hospitalier De Pau
- Department Name
- Neuroradiologie Interventionnelle
- Principal Investigator Name
- Sebastian RICHTER
- Principal Investigator Email
- johannsebastian.richter@ch-pau.fr
- Contact Person Name
- Sebastian RICHTER
- Contact Person Email
- johannsebastian.richter@ch-pau.fr
- Site Name
- Centre Hospitalier Regional Universitaire De Tours
- Department Name
- Neuroradiologie Vasculaire Interventionnelle
- Principal Investigator Name
- Grégoire BOULOUIS
- Principal Investigator Email
- G.BOULOUIS@chu-tours.fr
- Contact Person Name
- Grégoire BOULOUIS
- Contact Person Email
- G.BOULOUIS@chu-tours.fr
- Site Name
- Centre Hospitalier Universitaire De Dijon
- Department Name
- Neuroradiologie et imagerie des urgences
- Principal Investigator Name
- Pierre-Olivier COMBY
- Principal Investigator Email
- pierre-olivier.comby@chu-dijon.fr
- Contact Person Name
- Pierre-Olivier COMBY
- Contact Person Email
- pierre-olivier.comby@chu-dijon.fr
- Site Name
- CHRU De Nancy
- Department Name
- Neuroradiologie Diagnostique et Thérapeutique
- Principal Investigator Name
- Benjamin GORY
- Principal Investigator Email
- b.gory@chru-nancy.fr
- Contact Person Name
- Benjamin GORY
- Contact Person Email
- b.gory@chru-nancy.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Neuroradiologie Interventionnelle
- Principal Investigator Name
- Raoul POP
- Principal Investigator Email
- raoul.pop@chru-strasbourg.fr
- Contact Person Name
- Raoul POP
- Contact Person Email
- raoul.pop@chru-strasbourg.fr
- Site Name
- Centre Hospitalier Pasteur
- Department Name
- Radiodiagnostic et Imagerie Médicale
- Principal Investigator Name
- Pablo Ariel LEBEDINSKY
- Principal Investigator Email
- pablo.lebedinski@ch-colmar.fr
- Contact Person Name
- Pablo Ariel LEBEDINSKY
- Contact Person Email
- pablo.lebedinski@ch-colmar.fr
Sponsor
Primary sponsor
- Full Name
- CHRU De Nancy
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- ACTILYSE, poudre et solvant pour solution injectable et perfusion
- Active Substance
- Alteplase
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Intra-arterial (INTRAARTERIAL USE)
- Route
- Intra-arterial
- Authorisation Status
- Marketing authorisation exists for IV indication (used intra-arterially in this trial, outside scope of MA)
- Maximum Dose
- 20 mg
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