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Intravenous Thrombolysis With Tenecteplase Plus Thrombectomy Versus Thrombectomy Alone In Patients With A Large Ischemic Stroke: A Multicenter Randomized Controlled Trial (IVT-ALL-IN)
Sponsor: Assistance Publique - Hôpitaux de Paris
Summary
Stroke is a frequent and severe disease worldwide, representing the second leading cause of death and the leading cause of acquired disability. Over the last thirty years, reperfusion therapies have transformed the prognosis of ischemic stroke. For patients with acute ischemic stroke due to large-vessel occlusion (LVOS) and a small- to moderate-sized irreversibly injured tissue (core), the recommended treatment consists of intravenous thrombolysis (IVT) followed by mechanical thrombectomy (MT). However, for the fifth of LVOS patients with large core, MT has demonstrated its effectiveness, but the benefits of prior IVT remain unclear. In fact, no randomized trial has compared IVT+MT and MT alone in this population. Tenecteplase is increasingly replacing alteplase for LVOS due to two key advantages. First, it is administered as a single intravenous bolus, which speeds up treatment and transfers. Second, it improves reperfusion and functional outcomes in LVOS patients without large core. Emerging real-world evidence with tenecteplase reports lower rates of symptomatic intracranial hemorrhage than alteplase, suggesting superior overall efficacy. To date, no randomized trial has explored the benefit of tenecteplase in LVOS patients with large core. The IVT ALL IN trial is a French multicenter open randomized controlled trial with two parallel groups (IVT with tenecteplase followed by MT \[IVT+MT\] vs MT alone) and blinded endpoint assessment following a PROBE design. Its main objective is to assess which treatment strategy between IVT+MT and MT alone has a superior efficacy in terms of 3-month good functional outcome, defined as a modified Rankin scale (mRS) score ≤ 3 at 3 months, for LVOS patients with large core of the anterior circulation. Our trial will provide high-level evidence on the optimal reperfusion treatment strategy for LVOS patients with large ischemic core, who currently still have a low likelihood of achieving a favorable neurological outcome.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
486
Start Date
2026-06-15
Completion Date
2029-07-01
Last Updated
2026-05-22
Healthy Volunteers
No
Conditions
Interventions
Intravenous administration
Intravenous administration of Tenecteplase (0.25 mg/kg, maximum 25 mg) followed by mechanical thrombectomy (MT)
MT alone
Mechanical thrombectomy alone
Locations (36)
CH Pays d'Aix - Site d'Aix-en-Provence
Aix-en-Provence, France
CHU Besançon
Besançon, France
CHU Bordeaux - Groupe Hospitalier Pellegrin
Bordeaux, France
CHU Brest - Hôpital de la Cavale Blanche
Brest, France
HCL - Hôpital Pierre Wertheimer
Bron, France
CHU Caen Normandie
Caen, France
CH Sud Francilien
Corbeil-Essonnes, France
AP-HP - Hôpital Henri Mondor-Albert Chenevier
Créteil, France
CHU Dijon Bourgogne
Dijon, France
CH Gonesse
Gonesse, France
CHU Grenoble Alpes - Site Nord
Grenoble, France
CH Versailles - Hôpital André Mignot
Le Chesnay, France
AP-HP - Hôpital Bicêtre
Le Kremlin-Bicêtre, France
CHU Lille - Hôpital Roger Salengro
Lille, France
CHU Limoges - Hôpital Dupuytren
Limoges, France
AP-HM - Hôpital de la Timone
Marseille, France
CHU Montpellier - Hôpital Saint-Eloi
Montpellier, France
CHRU Nancy - Hôpital Central
Nancy, France
CHU Nantes - Hôpital Nord Laennec
Nantes, France
CHU Nice - Hôpital Pasteur
Nice, France
AP-HP - Hôpital Lariboisiere-Fernand Widal
Paris, France
Hôpital Pitié-Salpêtrière
Paris, France
GH Paris Saint-Joseph - Hôpital Paris Saint-Joseph
Paris, France
GHU Paris Psychiatrie et Neurosciences - Hôpital Sainte-Anne
Paris, France
AP-HP - Hôpital Bichat
Paris, France
Fondation Adolphe de Rothschild
Paris, France
CH Perpignan
Perpignan, France
CHU Poitiers - Hôpital de La Milétrie
Poitiers, France
CHU Reims - Hôpital Maison Blanche
Reims, France
CHU Rennes - Hôpital Pontchaillou
Rennes, France
CHU Rouen - Hôpital Charles-Nicolle
Rouen, France
CH Saint-Denis - Hôpital Delafontaine
Saint-Denis, France
CHU Saint-Etienne - Hôpital Nord
Saint-Etienne, France
Hôpitaux universitaires de Strasbourg - Hôpital de Hautepierre
Strasbourg, France
Hôpital Foch
Suresnes, France
CHRU Tours - Hôpital Bretonneau
Tours, France