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New combo treatment could help more Large-Stroke patients walk again

NCT ID NCT07603440

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving a clot-busting drug called tenecteplase before a mechanical clot removal procedure helps people with large ischemic strokes recover better than the procedure alone. About 486 adults with large-vessel occlusion strokes will be randomly assigned to one of two groups. The main goal is to see if more patients can walk independently three months after treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tenecteplase (a clot-busting drug given as a single injection)
What this could lead to
If it works, this could show that adding tenecteplase before clot removal helps more people with large strokes recover enough to walk independently.
What could go wrong
This is a phase 3 trial, but it's still early and the benefit of tenecteplase in large-core strokes is unproven. There is a risk of bleeding in the brain, though tenecteplase may be safer than older drugs.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 486 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria : * Age ≥ 18 years * mRS ≤ 1 before stroke * Anterior circulation large vessel occlusion stroke eligible to mechanical thrombectomy (MT) within 24 hours of onset or unknown onset with a DWI-FLAIR mismatch * 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 * Written informed consent signed by the patient or the trustworthy person / family member / close relative, or inclusion in case of emergency (to note, written informed consent will 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 : * Anterior circulation stroke with a distal occlusion not eligible to MT * Posterior circulation stroke * Pregnancy or breastfeeding woman * Any contraindication to IVT, based on the Metalyse SmPC and the latest AHA/ASA guidelines on IVT (Prabhakaran et al. Stroke. 2026), 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 * Hypersensitivity to the active substance or to any of its excipients * 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 * 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) * Anticipated life expectancy of less than 3 months * Participation in another interventional clinical trial evaluating a health product or any randomized clinical trial * Absence of affiliation to National French social security system * Under legal protection measure (tutorship or curatorship) and patient deprived of freedom

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Conditions

The condition(s) this trial relates to.

brain infarction brain ischemia cerebral infarction cerebrovascular disorder Ischemic Stroke large artery stroke stroke disorder vascular disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Stroke

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    36 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AP-HM - Hôpital de la Timone

    Marseille, 13005, France

  • AP-HP - Hôpital Bichat

    Paris, 75018, France

  • AP-HP - Hôpital Bicêtre

    Le Kremlin-Bicêtre, 94275, France

  • AP-HP - Hôpital Henri Mondor-Albert Chenevier

    Créteil, 94000, France

  • AP-HP - Hôpital Lariboisiere-Fernand Widal

    Paris, 75010, France

  • CH Gonesse

    Gonesse, 95500, France

  • CH Pays d'Aix - Site d'Aix-en-Provence

    Aix-en-Provence, 13100, France

  • CH Perpignan

    Perpignan, 66046, France

  • CH Saint-Denis - Hôpital Delafontaine

    Saint-Denis, 93200, France

  • CH Sud Francilien

    Corbeil-Essonnes, 91106, France

  • CH Versailles - Hôpital André Mignot

    Le Chesnay, 78000, France

  • CHRU Nancy - Hôpital Central

    Nancy, 54035, France

  • CHRU Tours - Hôpital Bretonneau

    Tours, 37000, France

  • CHU Besançon

    Besançon, 25030, France

  • CHU Bordeaux - Groupe Hospitalier Pellegrin

    Bordeaux, 33076, France

  • CHU Brest - Hôpital de la Cavale Blanche

    Brest, 29609, France

  • CHU Caen Normandie

    Caen, 14000, France

  • CHU Dijon Bourgogne

    Dijon, 21079, France

  • CHU Grenoble Alpes - Site Nord

    Grenoble, 38043, France

  • CHU Lille - Hôpital Roger Salengro

    Lille, 59000, France

  • CHU Limoges - Hôpital Dupuytren

    Limoges, 87042, France

  • CHU Montpellier - Hôpital Saint-Eloi

    Montpellier, 34295, France

  • CHU Nantes - Hôpital Nord Laennec

    Nantes, 44093, France

  • CHU Nice - Hôpital Pasteur

    Nice, 6000, France

  • CHU Poitiers - Hôpital de La Milétrie

    Poitiers, 86000, France

  • CHU Reims - Hôpital Maison Blanche

    Reims, 51100, France

  • CHU Rennes - Hôpital Pontchaillou

    Rennes, 35033, France

  • CHU Rouen - Hôpital Charles-Nicolle

    Rouen, 76031, France

  • CHU Saint-Etienne - Hôpital Nord

    Saint-Etienne, 42055, France

  • Fondation Adolphe de Rothschild

    Paris, 75019, France

  • GH Paris Saint-Joseph - Hôpital Paris Saint-Joseph

    Paris, 75014, France

  • GHU Paris Psychiatrie et Neurosciences - Hôpital Sainte-Anne

    Paris, 75014, France

  • HCL - Hôpital Pierre Wertheimer

    Bron, 69500, France

  • Hôpital Foch

    Suresnes, 92150, France

  • Hôpital Pitié-Salpêtrière

    Paris, 75013, France

  • Hôpitaux universitaires de Strasbourg - Hôpital de Hautepierre

    Strasbourg, 67098, France

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