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Tenecteplase given before hospital transfer for clot removal in late-arriving acute stroke

Tests tenecteplase in adults with a large-vessel stroke awaiting transfer for thrombectomy.

Key facts

Who runs it
Fondation A De Rothschild
Where
Angouleme Cedex 9, Auch Cedex, Aulnays-Sous-Bois, Bar-Le-Duc, Béziers, Bordeaux, Boulogne-sur-Mer, Bron, Caen Cedex 9, Carcassonne Cedex 9, Chalon Sur Saone Cedex, Chambéry, Cherbourg-En-Cotentin, Clermont Ferrand Cedex 1, Corbeil Essonnes Cedex, Creteil, Dijon, Dunkirk Cedex 1, Epinal, Garches, Gonesse, Grenoble Cedex 9, La Roche Sur Yon Cedex 9, Le Chesnay Cedex, Le Coudray, Le Puy-En-Velay, Libourne Cedex, Lille Cedex, Meaux, Montelimar Cedex, Montivilliers, Montpellier Cedex 5, Nancy Cedex, Orsay, Paris, Paris Cedex 10, Paris Cedex 18, Paris Cedex 19, Poissy, Poitiers, Pontoise, Roubaix, Rouen Cedex, Saint Nazaire Cedex, Saint-Herblain, St Denis Cedex, Suresnes, Toulouse, Valence, Verdun, and Villefranche Sur Saone Cedex, FranceSee the 53 sites
Registry title
Tenecteplase for the treatment of acute stroke in the late time window before inter-hospital transfer for thrombectomy: a randomized controlled trial
Status
Not yet recruiting
Phase
Phase 3
People taking part
592 people, planned
Started
1 Oct 2026
Expected to end
1 Jan 2030
Type of study
Interventional
Record updated
25 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a stroke caused by a blocked large brain artery, who arrive at a stroke centre 4.5 to 24 hours after symptoms began and need transfer to another hospital for a clot-removal procedure.

Age
18 years or older
Sex
All sexes can join
Disease stage
Stroke with a large vessel blocked, seen within 4.5 to 24 hours of symptom start or last time seen well; NIHSS score of 6 or more; scans must show brain tissue that can still be saved
Earlier treatment
Must not have had a stroke within the last 3 months; must not be on effective doses of oral blood thinners
Biomarker or test result
Scan results: perfusion scans with ischemic core volume ≤70 mL, Tmax 6 volume ≥30 mL, mismatch ratio ≥1.8 and mismatch volume ≥15 mL; or, without perfusion scans, ASPECTS score ≥6 for ICA or M1, ≥7 for M2, pc-ASPECTS ≥7 for basilar

Main reasons for not taking part

  • Any reason a clot-dissolving drug cannot be given, such as bleeding disorders or blood pressure that stays above 185/110 mmHg
  • Brain bleeding, brain or spine surgery, or heart attack within the last 3 months
  • Disability before the stroke (pre-stroke mRS above 2)
  • Pregnant or breast-feeding women
  • Taking part in another interventional study during follow-up

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • Age ≥18 years old
  • Admitted in a PSC within 4.5-to-24-hours from stroke symptom onset (or last know well time if symptom onset was not observed)
  • Baseline NIHSS score ≥6
  • Imaging evidence of a large vessel occlusion (intracranial internal carotid artery [ICA], first or second segment of the middle cerebral artery M1 or proximal M2 or basilar artery)
  • Target mismatch profile as evidenced by one of the below criteria • If perfusion imaging is available: CT- or MR-perfusion mismatch: occlusion of ICA or M1 or M2 and an estimated ischemic core volume ≤70 mL, a Tmax 6 volume ≥30 mL, a mismatch ratio ≥1.8, and a mismatch volume ≥15 mL • If perfusion imaging is not available: MRA/CTA-ASPECTS mismatch: occlusion of ICA or M1 and ASPECTS score ≥6, or M2 and ASPECTS score ≥7, or basilar and pc-ASPECTS ≥7 (ASPECTS can be assessed on DWI or non-contrast CT)
  • Patients requiring inter-hospital transfer for an endovascular procedure

Who cannot take part

  • Participation in other interventional research (RIPH 1, clinical drug trials, clinical investigations) for the duration of their follow-up
  • Pre-stroke mRS > 2 (significant disability, unable to carry out all usual duties and activities independently before stroke)
  • Any contraindication to IVT, based on the Metalyse SmPC and the latest AHA/ASA guidelines on IVT (Prabhakaran et al. Stroke. 2026), other than the time criteria: • Persistent incapacity to lower blood pressure under 185/110 mmHg • Respiratory or hemodynamic failure • Hypersensitivity to the active substance or to any of its excipients or hypersensitivity to gentamicin (a trace residue from the manufacturing process • Known haemorrhagic diathesis • Bacterial endocarditis, pericarditis • Acute pancreatitis • Significant impairment of hepatic function, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and progressive hepatitis • Active ulcerative gastrointestinal disease • Neoplasia associated with an increased risk of haemorrhage • Known bleeding disorders, such as thrombocytopenia (platelet count < 100 G/L) or severe coagulopathy (INR > 1.7, activated partial thromboplastin time > 40s or prothrombin time > 15s) either currently or within the last 3 weeks • Treatment with effective doses of oral anticoagulants (e.g. vitamin K antagonists with an INR > 1.7) • Any history of intracerebral neoplasm • History of intracranial / spinal surgery or acute spinal cord injury within 3 months • Recent ST-segment elevation myocardial infarction within 3 months • Major non-central nervous system surgery, biopsy of a parenchymal organ or significant trauma within the last 10 days • Recent moderate to severe traumatic brain injury • Known arterial or venous malformation, except unruptured intracranial aneurysm • History of intracerebral haemorrhage within 3 months • Known cerebral amyloid angiopathy • History of acute ischaemic stroke within 3 months
  • Known pregnant or breast-feeding woman
  • Patient benefiting from legal protection

Where in France

  • Centre Hospitalier D AngoulemeAngouleme Cedex 9, FranceNot yet recruiting
  • Centre Hospitalier D AuchAuch Cedex, FranceNot yet recruiting
  • Ctre Hospitalier Intercomm R BallangerAulnays-Sous-Bois, FranceNot yet recruiting
  • Centre Hospitalier De Bar-Le-Duc Fains-VeelBar-Le-Duc, FranceNot yet recruiting
  • Centre Hospitalier de BéziersBéziers, FranceNot yet recruiting
  • Centre hospitalier Universitaire de BordeauxBordeaux, FranceNot yet recruiting
  • Centre Hospitalier de Boulogne-Sur-MerBoulogne-sur-Mer, FranceNot yet recruiting
  • Hospices Civils de LyonBron, FranceNot yet recruiting
  • Centre Hospitalier Universitaire De Caen NormandieCaen Cedex 9, FranceNot yet recruiting
  • Centre Hospitalier De CarcassonneCarcassonne Cedex 9, FranceNot yet recruiting
  • Centre Hospitalier William MoreyChalon Sur Saone Cedex, FranceNot yet recruiting
  • Centre Hospitalier Métropole SavoieChambéry, FranceNot yet recruiting
  • Centre Hospitalier Public Du CotentinCherbourg-En-Cotentin, FranceNot yet recruiting
  • University Hospital Of Clermont-FerrandClermont Ferrand Cedex 1, FranceNot yet recruiting
  • Centre Hospitalier Sud FrancilienCorbeil Essonnes Cedex, FranceNot yet recruiting
  • Assistance Publique Hopitaux De ParisCreteil, FranceNot yet recruiting
  • Centre Hospitalier Universitaire de DijonDijon, FranceNot yet recruiting
  • L’Hopital Alexandra LepeveDunkirk Cedex 1, FranceNot yet recruiting
  • Centre Hospitalier Intercommunal Emile DurkheimEpinal, FranceNot yet recruiting
  • Raymond-Poincare HospitalGarches, FranceNot yet recruiting
  • Centre Hospitalier GeneralGonesse, FranceNot yet recruiting
  • Centre Hospitalier Universitaire Grenoble AlpesGrenoble Cedex 9, FranceNot yet recruiting
  • Centre Hospitalier Departemental VendeeLa Roche Sur Yon Cedex 9, FranceNot yet recruiting
  • Centre Hospitalier De VersaillesLe Chesnay Cedex, FranceNot yet recruiting
  • Les Hopitaux De ChartresLe Coudray, FranceNot yet recruiting
  • Centre Hospitalier Du PuyLe Puy-En-Velay, FranceNot yet recruiting
  • Centre Hospitalier De Libourne Robert BoulinLibourne Cedex, FranceNot yet recruiting
  • Centre Hospitalier Universitaire De LilleLille Cedex, FranceNot yet recruiting
  • Groupement Des Hopitaux De L'Institut Catholique De LilleLille Cedex, FranceNot yet recruiting
  • Grand Hopital de l'Est FrancilienMeaux, FranceNot yet recruiting
  • Groupement Hospitalier Portes De ProvenceMontelimar Cedex, FranceNot yet recruiting
  • Groupe Hospitalier Du HavreMontivilliers, FranceNot yet recruiting
  • Centre Hospitalier Universitaire De MontpellierMontpellier Cedex 5, FranceNot yet recruiting
  • CHRU De NancyNancy Cedex, FranceNot yet recruiting
  • Groupe Hospitalier Nord EssonneOrsay, FranceNot yet recruiting
  • Fondation Hôpital Saint-JosephParis, FranceNot yet recruiting
  • Groupe Hospitalier Universitaire Paris Psychiatrie Et NeuroscienceParis, FranceNot yet recruiting
  • Assistance Publique Hopitaux De ParisParis Cedex 10, FranceNot yet recruiting
  • Assistance Publique Hopitaux De ParisParis Cedex 18, FranceNot yet recruiting
  • Fondation A De RothschildParis Cedex 19, FranceNot yet recruiting
  • Centre Hospitalier Intercommunal De Poissy Saint GermainPoissy, FranceNot yet recruiting
  • Centre Hospitalier Universitaire de PoitiersPoitiers, FranceNot yet recruiting
  • Hôpital NOVOPontoise, FranceNot yet recruiting
  • Centre hospitalier de RoubaixRoubaix, FranceNot yet recruiting
  • Centre Hospitalier Universitaire RouenRouen Cedex, FranceNot yet recruiting
  • Centre Hospitalier Saint NazaireSaint Nazaire Cedex, FranceNot yet recruiting
  • Centre Hospitalier Universitaire de NantesSaint-Herblain, FranceNot yet recruiting
  • Centre Hospitalier General De St DenisSt Denis Cedex, FranceNot yet recruiting
  • Hospital FochSuresnes, FranceNot yet recruiting
  • Centre Hospitalier Universitaire de ToulouseToulouse, FranceNot yet recruiting
  • Centre Hospitalier ValenceValence, FranceNot yet recruiting
  • Centre Hospitalier Verdun Saint MihielVerdun, FranceNot yet recruiting
  • Les Hopitaux Nord-OuestVillefranche Sur Saone Cedex, FranceNot yet recruiting

About the trial

What the trial wants to find out

To assess the efficacy of IVT with tenecteplase 0.25mg/kg initiated 4.5 to 24-hours after last time seen well on functional outcome at 90 days in AIS-LVO patients who have evidence of salvageable ischemic brain tissue on CT or MRI and who are planned for an inter-hospital transfer to undergo an endovascular procedure.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Tenecteplase for the treatment of acute stroke in the late time window before inter-hospital transfer for thrombectomy: a randomized controlled trial
Plain-language title
Tenecteplase given before hospital transfer for clot removal in late-arriving acute strokeGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
25 August 2026