Intravenous Thrombolysis With Tenecteplase Plus Thrombectomy Versus Thrombectomy Alone In Patients With A Large Ischemic Stroke: A Multicenter Randomized Controlled Trial (IVT-ALL-IN)

Starting soon · Phase 3

Conditions studied: Stroke

In brief

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 facts

Study ID

NCT07603440

Run by

Assistance Publique - Hôpitaux de Paris

People needed

486

Starts

2026-06-15

Expected to finish

2029-07-01

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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))

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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