Clinical trial • Phase III • Neurology
TENECTEPLASE for Ischaemic stroke|Large vessel occlusion stroke (LVOS)
Phase III trial of TENECTEPLASE for Ischaemic stroke|Large vessel occlusion stroke (LVOS).
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Ischaemic stroke|Large vessel occlusion stroke (LVOS)
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 15-12-2025
- First CTIS Authorization Date
- 12-03-2026
Trial design
Randomised, open-label, tenecteplase (metalyse 5 000 units (25 mg) powder for solution for injection; tenecteplase iv bolus, up to 25 mg) followed by mechanical thrombectomy (per standard protocol) versus mechanical thrombectomy alone.-controlled Phase III trial in France.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Tenecteplase (Metalyse 5 000 units (25 mg) powder for solution for injection; tenecteplase IV bolus, up to 25 mg) followed by mechanical thrombectomy (per standard protocol) versus mechanical thrombectomy alone.
- Target Sample Size
- 486
- Trial Duration For Participant
- 365
Eligibility
Recruits 486 Vulnerable population flag set. Patients under legal protection (tutorship or curatorship) and patients deprived of freedom are excluded. Consent may be provided by the patient or by a trustworthy person / family member / close relative; inclusion in emergency is allowed with written informed consent required as soon as possible thereafter (per article 35 of EU regulation 536/2014). Dedicated consent documents exist for trusted person/relative (trusted person-relative ICF) and adult-specific ICFs are provided..
- Pregnancy Exclusion
- Pregnancy or breastfeeding woman
- Vulnerable Population
- Vulnerable population flag set. Patients under legal protection (tutorship or curatorship) and patients deprived of freedom are excluded. Consent may be provided by the patient or by a trustworthy person / family member / close relative; inclusion in emergency is allowed with written informed consent required as soon as possible thereafter (per article 35 of EU regulation 536/2014). Dedicated consent documents exist for trusted person/relative (trusted person-relative ICF) and adult-specific ICFs are provided.
Inclusion criteria
- {"criterion_text":"- Age ≥ 18 years"}
- {"criterion_text":"- mRS ≤ 1 before stroke"}
- {"criterion_text":"- Anterior circulation LVOS eligible to MT within 24 hours of onset or unknown onset with a DWI-FLAIR mismatch"}
- {"criterion_text":"- Large core defined either as: - ASPECTS 2-5 or a core volume between 70 and 130 ml on MRI or perfusion CT for patients with process times compatible with IVT administration within 4.5 hours of onset or unknown onset with process times compatible with IVT administration within 4.5 hours of last seen well or unknown onset with a DWI-FLAIR mismatch - ASPECTS 2- 5 with a core volume ≤ 70 ml and core/perfusion mismatch > 1.2 for patients with process times compatible with IVT administration within 4.5 and 9 hours of onset, defined as the mid-point between last known to be normal and symptoms constatation in case of unknown onset"}
- {"criterion_text":"- Written informed consent signed by the patient or the trustworthy person / family member / close relative, or inclusion in case of emergency. (To note, in the latter case, written informed consent should be signed by the patient (if needed, by trustworthy person, family member or close relative) as soon as possible (article 35 of the European regulation N°536/2014))."}
Exclusion criteria
- {"criterion_text":"- Anterior circulation stroke with a distal occlusion not eligible to MT"}
- {"criterion_text":"- Posterior circulation stroke"}
- {"criterion_text":"- Pregnancy or breastfeeding woman"}
- {"criterion_text":"- Any contraindication to IVT other than those related to the NIHSS score upper limit, infarct size and symptoms-to-onset time, such as (but not limited to): * Persistent incapacity to lower blood pressure under 185/110 mmHg * Respiratory or hemodynamic failure * Externalized bleeding"}
- {"criterion_text":"- Any contra-indication to MT: * Contra-indication to femoral, radial or humeral arterial puncture * Allergy to iodinated contrast media * Known Renal insufficiency at inclusion time (confirmed biologically by a creatinine clearance < 30 ml/min calculated with the Cockcroft-Gault formula)"}
- {"criterion_text":"- Anticipated life expectancy of less than 3 months"}
- {"criterion_text":"- Participation in another interventional clinical trial evaluating a health product or any randomized clinical trial"}
- {"criterion_text":"- Absence of affiliation to National French social security system"}
- {"criterion_text":"- Under legal protection measure (tutorship or curatorship) and patient deprived of freedom"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary outcome is the rate of good functional outcome (independent ambulation) at 3 months defined as a modified Rankin scale (mRS) score of 0-3. mRS scores will be determined by certified raters unaware of the treatment arm or baseline characteristics of the individual patient by in person interview or, if not possible, by telephone.","definition_or_measurement_approach":"Good functional outcome defined as mRS score 0-3 at 3 months; mRS determined by certified raters blinded to treatment and baseline characteristics by in-person interview or, if not possible, by telephone."}
Secondary endpoints
- {"endpoint_text":"- Clinical outcomes -\tearly neurological improvement, defined as a ≥ 8-points decrease of the NIHSS score or a NIHSS score ≤ 1 at day 1 -\t3-month functional independence (mRS score ≤ 2) -\tdistribution of 3-month mRS scores -\tone-year independent ambulation (mRS score ≤ 3) -\tone-year functional independence (mRS score ≤ 2)","definition_or_measurement_approach":"Early neurological improvement defined as ≥8-point decrease in NIHSS or NIHSS ≤1 at day 1; 3-month and 1-year functional outcomes measured by mRS with specified thresholds; distribution of mRS at 3 months."}
- {"endpoint_text":"- Radiological outcomes -\tsuccessful, excellent and complete recanalisation rates defined as an extended Treatment In Cerebral Ischemia (eTICI) scores of 2b50/2b67/2c/3, 2c/3 and 3 respectively on the first angiographic run, after the first pass and at the end of the procedure -\tmean change in infarct volume from baseline at day 1, defined as: (day 1 volume) – (baseline volume","definition_or_measurement_approach":"Recanalisation rates defined by eTICI categories (2b50/2b67/2c/3 etc.) measured on angiographic runs (first run, after first pass, end of procedure); mean change in infarct volume from baseline to day 1 calculated as (day 1 volume) – (baseline volume)."}
- {"endpoint_text":"- Safety outcomes -\tearly neurological worsening defined as a ≥ 4-point increase on the NIHSS score within 24 hours due to the stroke itself -\tintracranial hemorrhage (ICH) according to the Heidelberg Bleeding Classification -\tsymptomatic ICH, scored according to the Heidelberg Bleeding Classification -\t3-month and 1-year mortality -\tadverse events -\tserious adverse events","definition_or_measurement_approach":"Early neurological worsening = ≥4-point increase on NIHSS within 24 hours attributable to stroke; ICH and symptomatic ICH adjudicated per Heidelberg Bleeding Classification; mortality at 3 months and 1 year; standard AE/SAE reporting."}
- {"endpoint_text":"- Incremental cost-utility ratio","definition_or_measurement_approach":"Health economic outcome comparing incremental cost-utility between treatment strategies (details not further specified in CTIS JSON)."}
Recruitment
- Planned Sample Size
- 486
- Recruitment Window Months
- 36
- Consent Approach
- Written informed consent required from the patient or from a trustworthy person / family member / close relative. Emergency inclusion allowed with written informed consent to be obtained from the patient (or if needed from the trustworthy person/family/close relative) as soon as possible thereafter (per Article 35 of EU regulation 536/2014). Separate subject information and informed consent forms exist for adults and for trusted person/relative; no participant assent for minors (trial enrols adults ≥18). Languages of consent documents are not specified in the CTIS JSON.
Geography
- Total Number Of Sites
- 36
- Total Number Of Participants
- 486
France
- Earliest CTIS Part Ii Submission Date
- 26-01-2026
- Latest Decision Or Authorization Date
- 12-03-2026
- Processing Time Days
- 45
- Number Of Sites
- 36
- Number Of Participants
- 486
Sites
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Neurology
- Principal Investigator Name
- Caroline ARQUIZAN
- Principal Investigator Email
- c-arquizan@chu-montpellier.fr
- Contact Person Name
- Caroline ARQUIZAN
- Contact Person Email
- c-arquizan@chu-montpellier.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
- 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 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 General De St Denis
- Department Name
- Neurology
- Principal Investigator Name
- Carole HENRY
- Principal Investigator Email
- carole.henry@ch-stdenis.fr
- Contact Person Name
- Carole HENRY
- Contact Person Email
- carole.henry@ch-stdenis.fr
- Site Name
- Centre Hospitalier Sud Francilien
- Department Name
- Neurology
- Principal Investigator Name
- Nicolas CHAUSSON
- Principal Investigator Email
- nicolas.chausson@chsf.fr
- Contact Person Name
- Nicolas CHAUSSON
- Contact Person Email
- nicolas.chausson@chsf.fr
- Site Name
- Centre Hospitalier De Perpignan
- Department Name
- Neurology
- Principal Investigator Name
- DENIS SABLOT
- Principal Investigator Email
- denis.sablot@ch-perpignan.fr
- Contact Person Name
- DENIS SABLOT
- Contact Person Email
- denis.sablot@ch-perpignan.fr
- Site Name
- Hospital Foch
- Department Name
- Neurology
- Principal Investigator Name
- Bertrand LAPERGUE
- Principal Investigator Email
- b.lapergue@hopital-foch.com
- Contact Person Name
- Bertrand LAPERGUE
- Contact Person Email
- b.lapergue@hopital-foch.com
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Neurology
- Principal Investigator Name
- Laurent SUISSA
- Principal Investigator Email
- laurent.suissa@ap-hm.fr
- Contact Person Name
- Laurent SUISSA
- Contact Person Email
- laurent.suissa@ap-hm.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
- 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 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
- Hopitaux Universitaires Pitie Salpetriere
- Department Name
- Neurology
- Principal Investigator Name
- Gaspard GERSCHENFELD
- Principal Investigator Email
- gaspard.gerschenfeld@aphp.fr
- Contact Person Name
- Gaspard GERSCHENFELD
- Contact Person Email
- gaspard.gerschenfeld@aphp.fr
- Site Name
- Centre Hospitalier Du Pays D Aix Centre Hospitalier Intercommunal Aix-Pertuis
- Department Name
- Neurology
- Principal Investigator Name
- Silvia DI LEGGE
- Principal Investigator Email
- sdilegge@ch-aix.fr
- Contact Person Name
- Silvia DI LEGGE
- Contact Person Email
- sdilegge@ch-aix.fr
- 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
- Assistance Publique Hopitaux De Paris (46 Rue Henri Huchard)
- Department Name
- Neurology
- Principal Investigator Name
- Philippa LAVALLEE
- Principal Investigator Email
- philippa.lavallee@aphp.fr
- Contact Person Name
- Philippa LAVALLEE
- Contact Person Email
- philippa.lavallee@aphp.fr
- Site Name
- Bicetre Hospital
- Department Name
- Neurology
- Principal Investigator Name
- Laura VENDITTI
- Principal Investigator Email
- laura.venditti@aphp.fr
- Contact Person Name
- Laura VENDITTI
- Contact Person Email
- laura.venditti@aphp.fr
- Site Name
- GIE Groupe hospitalier Paris Saint-Joseph/Vinci
- Department Name
- Neurology
- Principal Investigator Name
- Benjamin MAIER
- Principal Investigator Email
- bmaier@ghpsj.fr
- Contact Person Name
- Benjamin MAIER
- Contact Person Email
- bmaier@ghpsj.fr
- Site Name
- Centre Hospitalier De Versailles
- Department Name
- Neurology
- Principal Investigator Name
- Fernando PICO
- Principal Investigator Email
- fpico@ght78sud.fr
- Contact Person Name
- Fernando PICO
- Contact Person Email
- fpico@ght78sud.fr
- Site Name
- Assistance Publique Hopitaux De Paris (2 Rue Ambroise Pare)
- Department Name
- Neurology
- Principal Investigator Name
- Elodie BERTHET
- Principal Investigator Email
- elodie.berthet@aphp.fr
- Contact Person Name
- Elodie BERTHET
- Contact Person Email
- elodie.berthet@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Caen Normandie
- Department Name
- Neurology
- Principal Investigator Name
- Marion BOULANGER
- Principal Investigator Email
- boulanger-ma@chu-caen.fr
- Contact Person Name
- Marion BOULANGER
- Contact Person Email
- boulanger-ma@chu-caen.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Neurology
- Principal Investigator Name
- Lucie DELLA SCHIAVA
- Principal Investigator Email
- lucie.dellaschiava@chu-llile.fr
- Contact Person Name
- Lucie DELLA SCHIAVA
- Contact Person Email
- lucie.dellaschiava@chu-llile.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Neurology
- Principal Investigator Name
- Tae-Hee CHO
- Principal Investigator Email
- tae-hee.cho@chu-lyon
- Contact Person Name
- Tae-Hee CHO
- Contact Person Email
- tae-hee.cho@chu-lyon
- Site Name
- CHRU De Nancy
- Department Name
- Neurology
- Principal Investigator Name
- Sébastien RICHARD
- Principal Investigator Email
- s.richard@chru-nancy.fr
- Contact Person Name
- Sébastien RICHARD
- Contact Person Email
- s.richard@chru-nancy.fr
- Site Name
- Centre Hospitalier Et Universitaire De Limoges
- Department Name
- Neurology
- Principal Investigator Name
- Francisco MACIAN-MONTORO
- Principal Investigator Email
- francisco.macianmontoro@chu-limoges.fr
- Contact Person Name
- Francisco MACIAN-MONTORO
- Contact Person Email
- francisco.macianmontoro@chu-limoges.fr
- Site Name
- Centre Hospitalier Universitaire De Saint Etienne
- Department Name
- Neurology
- 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
- 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
- Site Name
- Centre Hospitalier Universitaire Rouen
- Department Name
- Neurology
- Principal Investigator Name
- Florient BASILE
- Principal Investigator Email
- florian.basille@chu-rouen.fr
- Contact Person Name
- Florient BASILE
- Contact Person Email
- florian.basille@chu-rouen.fr
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- Neurology
- Principal Investigator Name
- Nathalie NASR
- Principal Investigator Email
- nathalie.nasr@chu-poitiers.fr
- Contact Person Name
- Nathalie NASR
- Contact Person Email
- nathalie.nasr@chu-poitiers.fr
- Site Name
- Centre Hospitalier Universitaire De Dijon
- Department Name
- Neurology
- Principal Investigator Name
- Yannick BEJOT
- Principal Investigator Email
- yannick.bejot@chu-dijon.fr
- Contact Person Name
- Yannick BEJOT
- Contact Person Email
- yannick.bejot@chu-dijon.fr
- Site Name
- Assistance Publique Hopitaux De Paris (51 Av Du Mal De Lattre De Tassigny)
- 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
- 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
- CHU Besancon
- Department Name
- Neurology
- 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 General
- Department Name
- Neurology
- Principal Investigator Name
- Eric MANCHON
- Principal Investigator Email
- eric.manchon@ch-gonesse.fr
- Contact Person Name
- Eric MANCHON
- Contact Person Email
- eric.manchon@ch-gonesse.fr
- Site Name
- Groupe Hospitalier Universitaire Paris Psychiatrie Et Neuroscience
- Department Name
- Neurology
- Principal Investigator Name
- Guillaume TURC
- Principal Investigator Email
- g.turc@ghu-paris.fr
- Contact Person Name
- Guillaume TURC
- Contact Person Email
- g.turc@ghu-paris.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Neurology
- 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
Sponsor
Primary sponsor
- Full Name
- Assistance Publique Hopitaux De Paris
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- Metalyse 5 000 units (25 mg) powder for solution for injection
- Active Substance
- TENECTEPLASE
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- INTRAVENOUS BOLUS USE
- Route
- Intravenous bolus
- Authorisation Status
- Authorised (marketing authorisation EU/1/00/169/007)
- Starting Dose
- 25 mg
- Dose Levels
- 25 mg
- Frequency
- Single administration (per protocol for IV thrombolysis)
- Maximum Dose
- 25 mg
- Combination Treatment
- Yes
Related trials
Other published trials that may interest you.
- OCRELIZUMAB for Relapsing multiple sclerosis | Relapsing-remitting multiple sclerosis | Secondary progressive multiple sclerosis (active)
- CENOBAMATE for Partial-onset (focal) seizures
- Ocrelizumab for Relapsing multiple sclerosis | Relapsing-remitting multiple sclerosis | Active secondary progressive multiple sclerosis
- Clinical trial in Parkinson's disease
- Tenecteplase for Acute ischaemic stroke due to basilar artery occlusion | Posterior circulation ischaemic stroke