Intravenous Thrombolysis With Tenecteplase Plus Thrombectomy Versus Thrombectomy Alone In Patients With A Large Ischemic Stroke: A Multicenter Randomized Controlled Trial (IVT-ALL-IN)
IVT-ALL-IN
2 other identifiers
interventional
486
1 country
36
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 stroke
Started Jun 2026
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2026
CompletedFirst Posted
Study publicly available on registry
May 22, 2026
CompletedStudy Start
First participant enrolled
June 15, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2029
Study Completion
Last participant's last visit for all outcomes
July 1, 2029
May 22, 2026
May 1, 2026
3 years
May 18, 2026
May 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of good functional outcome (independent ambulation) at 3 months
defined as a modified Rankin scale (mRS) score of 0-3. mRS scores will be determined by certified raters unaware of the treatment arm or baseline characteristics of the individual patient by in person interview or, if not possible, by telephone. The Modified Rankin Scale (mRS) measures degree of disability/dependence after a stroke. Scores range from 0 to 6 (death)
3 months
Secondary Outcomes (17)
Early neurological improvement.
D1
3-month functional independence rate
3 months
Distribution of 3-month mRS scores
3 months
One-year independent ambulation rate
1 year
One-year functional independence
1 year
- +12 more secondary outcomes
Study Arms (2)
IVT with Tenecteplase followed by MT
EXPERIMENTALIntravenous administration of Tenecteplase (0.25 mg/kg, maximum 25 mg) followed by mechanical thrombectomy
Active Comparator: MT alone
ACTIVE COMPARATORMechanical thrombectomy alone
Interventions
Intravenous administration of Tenecteplase (0.25 mg/kg, maximum 25 mg) followed by mechanical thrombectomy (MT)
Eligibility Criteria
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
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
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
CH Pays d'Aix - Site d'Aix-en-Provence
Aix-en-Provence, 13100, France
CHU Besançon
Besançon, 25030, France
CHU Bordeaux - Groupe Hospitalier Pellegrin
Bordeaux, 33076, France
CHU Brest - Hôpital de la Cavale Blanche
Brest, 29609, France
HCL - Hôpital Pierre Wertheimer
Bron, 69500, France
CHU Caen Normandie
Caen, 14000, France
CH Sud Francilien
Corbeil-Essonnes, 91106, France
AP-HP - Hôpital Henri Mondor-Albert Chenevier
Créteil, 94000, France
CHU Dijon Bourgogne
Dijon, 21079, France
CH Gonesse
Gonesse, 95500, France
CHU Grenoble Alpes - Site Nord
Grenoble, 38043, France
CH Versailles - Hôpital André Mignot
Le Chesnay, 78000, France
AP-HP - Hôpital Bicêtre
Le Kremlin-Bicêtre, 94275, France
CHU Lille - Hôpital Roger Salengro
Lille, 59000, France
CHU Limoges - Hôpital Dupuytren
Limoges, 87042, France
AP-HM - Hôpital de la Timone
Marseille, 13005, France
CHU Montpellier - Hôpital Saint-Eloi
Montpellier, 34295, France
CHRU Nancy - Hôpital Central
Nancy, 54035, France
CHU Nantes - Hôpital Nord Laennec
Nantes, 44093, France
CHU Nice - Hôpital Pasteur
Nice, 6000, France
AP-HP - Hôpital Lariboisiere-Fernand Widal
Paris, 75010, France
Hôpital Pitié-Salpêtrière
Paris, 75013, France
GH Paris Saint-Joseph - Hôpital Paris Saint-Joseph
Paris, 75014, France
GHU Paris Psychiatrie et Neurosciences - Hôpital Sainte-Anne
Paris, 75014, France
AP-HP - Hôpital Bichat
Paris, 75018, France
Fondation Adolphe de Rothschild
Paris, 75019, France
CH Perpignan
Perpignan, 66046, 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
CH Saint-Denis - Hôpital Delafontaine
Saint-Denis, 93200, France
CHU Saint-Etienne - Hôpital Nord
Saint-Etienne, 42055, France
Hôpitaux universitaires de Strasbourg - Hôpital de Hautepierre
Strasbourg, 67098, France
Hôpital Foch
Suresnes, 92150, France
CHRU Tours - Hôpital Bretonneau
Tours, 37000, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gaspard GERSCHENFELD, MD, PhD
APHP
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2026
First Posted
May 22, 2026
Study Start (Estimated)
June 15, 2026
Primary Completion (Estimated)
July 1, 2029
Study Completion (Estimated)
July 1, 2029
Last Updated
May 22, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
- Access Criteria
- Researchers who provide a methodologically sound proposal.
The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.