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NOT YET RECRUITING
NCT07603440
PHASE3

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

View on ClinicalTrials.gov

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

DRUG

Intravenous administration

Intravenous administration of Tenecteplase (0.25 mg/kg, maximum 25 mg) followed by mechanical thrombectomy (MT)

PROCEDURE

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