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StrokePhase 3IVT-ALL-INNCT07603440

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

A Phase 3 study testing Intravenous administration and MT alone in people with Stroke, run by Assistance Publique - Hôpitaux de Paris at 36 sites in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
Intravenous administration and MT alone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
486 participants
Where
36 sitesFrance
Study dates
15 Jun 2026to 1 Jul 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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))

Who cannot join

  • 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
Show all 34Show fewer
  • 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

Trial locations and contacts

36 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Gaspard GERSCHENFELD, MD, PhD contact

1 84 82 82 85 ext. +33

gaspard.gerschenfeld@aphp.fr

Anne BISSERY contact

1 42 16 24 32 ext. +33

anne.bissery@aphp.fr

36 sites in 1 country

France36 sites

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

    Aix-en-Provence, 13100

    Silvia DI EGGE

  • CHU Besançon

    Besançon, 25030

    Guillaume CHARBONNIER

  • CHU Bordeaux - Groupe Hospitalier Pellegrin

    Bordeaux, 33076

    Igor SIBON

  • CHU Brest - Hôpital de la Cavale Blanche

    Brest, 29609

    Serge TIMSIT

  • HCL - Hôpital Pierre Wertheimer

    Bron, 69500

    Tae-Hee CHO

  • CHU Caen Normandie

    Caen, 14000

    Marion BOULANGER

  • CH Sud Francilien

    Corbeil-Essonnes, 91106

    Nicolas CHAUSSON

  • AP-HP - Hôpital Henri Mondor-Albert Chenevier

    Créteil, 94000

    Aymeric WITTWER

  • CHU Dijon Bourgogne

    Dijon, 21079

    Yannick BEJOT

  • CH Gonesse

    Gonesse, 95500

    Eric MANCHON

  • CHU Grenoble Alpes - Site Nord

    Grenoble, 38043

    Olivier DETANTE

  • CH Versailles - Hôpital André Mignot

    Le Chesnay, 78000

    Fernando PICO

  • AP-HP - Hôpital Bicêtre

    Le Kremlin-Bicêtre, 94275

    Laura VENDITTI

  • CHU Lille - Hôpital Roger Salengro

    Lille, 59000

    Lucie DELLA SCHIAVA

  • CHU Limoges - Hôpital Dupuytren

    Limoges, 87042

    Francisco MACIAN-MONTORO

  • AP-HM - Hôpital de la Timone

    Marseille, 13005

    Laurent SUISSA

  • CHU Montpellier - Hôpital Saint-Eloi

    Montpellier, 34295

    Caroline ARQUIZAN

  • CHRU Nancy - Hôpital Central

    Nancy, 54035

    Sébastien RICHARD

  • CHU Nantes - Hôpital Nord Laennec

    Nantes, 44093

    Benoit GUILLON

  • CHU Nice - Hôpital Pasteur

    Nice, 6000

    Barbara CASOLLA

  • AP-HP - Hôpital Lariboisiere-Fernand Widal

    Paris, 75010

    Elodie BERTHET

  • Hôpital Pitié-Salpêtrière

    Paris, 75013

    Gaspard GERSCHENFELD

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

    Paris, 75014

    Benjamin MAYER

  • GHU Paris Psychiatrie et Neurosciences - Hôpital Sainte-Anne

    Paris, 75014

    Guillaume TURC

  • AP-HP - Hôpital Bichat

    Paris, 75018

    Philippa LAVALLEE

  • Fondation Adolphe de Rothschild

    Paris, 75019

    Michael OBADIA

  • CH Perpignan

    Perpignan, 66046

    Denis SABLOT

  • CHU Poitiers - Hôpital de La Milétrie

    Poitiers, 86000

  • CHU Reims - Hôpital Maison Blanche

    Reims, 51100

    Solène MOULIN

  • CHU Rennes - Hôpital Pontchaillou

    Rennes, 35033

    Stéphane VANNIER

  • CHU Rouen - Hôpital Charles-Nicolle

    Rouen, 76031

    Florian BASILLE

  • CH Saint-Denis - Hôpital Delafontaine

    Saint-Denis, 93200

    Carole HENRY

  • CHU Saint-Etienne - Hôpital Nord

    Saint-Etienne, 42055

    Pierre GARNIER

  • Hôpitaux universitaires de Strasbourg - Hôpital de Hautepierre

    Strasbourg, 67098

    Valérie WOLFF

  • Hôpital Foch

    Suresnes, 92150

    Bertrand LAPERGUE

  • CHRU Tours - Hôpital Bretonneau

    Tours, 37000

    Marco PASI

Other trials in France

About this study

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.

Read the detailed description

The IVT ALL IN trial is a French multicenter open-label randomized controlled trial with two parallel groups and blinded endpoint assessment following a PROBE design. Patients will be randomized between two treatment groups: the IVT with tenecteplase followed by MT group (IVT+MT; experimental group) or the MT alone group (control group). Randomization will be minimized on center, core size (very large [ASPECTS 2-3] versus large [ASPECT 4-5] infarcts) and treatment time window (within 4.5 hours vs others).

We plan to include 486 adult patients with a pre-stroke mRS ≤ 1 presenting an anterior circulation LVOS eligible to MT within 24 hours of onset, or unknown onset with a DWI-FLAIR mismatch, with a large core defined 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

The primary endpoint is the rate of good functional outcome (independent ambulation) at 3 months defined as a modified Rankin scale (mRS) score of 0-3.

In the six recently published trials comparing MT to best medical management for LVOS patients with large ischemic cores, rates of 3-month independent ambulation (mRS ≤ 3) range from 30% to 47% with a weighted average around 38%. In the first 5 RCTs that focused on the benefit of MT in LVOS, the minimal difference observed with MT was 13%. With these assumptions and for a global alpha risk of 0.05, a power of 0.8 and a bilateral test, the total number of patients to randomize would be 486 patients (243 in each arm) to increase the rate of good functional outcomes from 38% in the control group to 51% in the experimental group accounting for 5% of lost to follow-up and considering one interim analysis and the final analysis using a Lan and Demets method with an O'Brien \& Fleming type alpha risk expenditure function We plan a sequential analysis of the primary outcome with 2 analyses: one interim analysis after the evaluation of the primary outcome for one third of the planned number of participants randomized, and a final analysis at the end of the study (end of follow-up of the last randomized participant). This sequential analysis is planned to be able to stop the trial in case of a large difference between the 2 groups or for futility if the conditional power is too low. It is planned according to the Lan \& DeMets approach with a control of alpha risk according to the method of O'Brien \& Flemming.

Conditions
Stroke
Being tested
Intravenous administration, MT alone
Keywords
Ischemic stroke, Thrombolysis, Cerebral Infarction, Cerebrovascular Disorders, Thrombectomy, Vascular Diseases, Plasminogen Activators, Brain Infarction, Brain Ischemia, large core infarct
Medical subject headings
Stroke, Ischemic Stroke, Cerebral Infarction, Cerebrovascular Disorders, Vascular Diseases, Brain Infarction, Brain Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intravenous administrationDrug

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

  • MT aloneProcedure or surgery

    Mechanical thrombectomy alone

Study groups in NCT07603440
Study groupRoleWhat they receive
IVT with Tenecteplase followed by MTExperimentalIntravenous administration of Tenecteplase (0.25 mg/kg, maximum 25 mg) followed by mechanical thrombectomy
Receives: Drug: Intravenous administration
Active Comparator: MT aloneActive comparatorMechanical thrombectomy alone
Receives: Procedure: MT alone

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 3 months

Secondary outcomes (17)

  1. Early neurological improvement.

    Defined as a ≥ 8-points decrease of the NIHSS score or a NIHSS score ≤ 1 at day 1.

    National Institutes of Health Stroke Scale (NIHSS) is a questionnaire to evaluate neurologic outcome and degree of recovery for patients with stroke.

    Scores range from 0 to 42 (worse)

    Measured: D1

  2. 3-month functional independence rate

    Defined as a 3-month mRS score of 0-2

    Measured: 3 months

  3. Distribution of 3-month mRS scores

    Ordinal analysis 3-month functional outcome

    Measured: 3 months

  4. One-year independent ambulation rate

    Defined as a 1-year mRS score of 0-3.

    Measured: 1 year

  5. One-year functional independence

    Defined as a 1-year mRS score of 0-2.

    Measured: 1 year

  6. Mean change in infarct volume from baseline at day 1

    Defined as (day 1 volume) - (baseline volume).

    Measured: Day 1

  7. Early neurological worsening.

    Defined as a ≥ 4-point increase on the NIHSS score within 24 hours due to the stroke itself.

    Measured: Day 1

  8. Intracerebral hemorrhage.

    Intracerebral hemorrhage defined according to the Heidelberg Bleeding Classification.

    Measured: Day 2

  9. Symptomatic intracerebral hemorrhage.

    Symptomatic intracerebral hemorrhage defined according to the Heidelberg Bleeding Classification.

    Measured: Day 2

  10. 3-month mortality rate.

    All-cause mortality.

    Measured: 3 months

  11. 1-year mortality rate.

    All-cause mortality.

    Measured: 1 year

  12. Medico-economic study.

    Incremental cost utility ratio analysis.

    Measured: 1 year

  13. Successful recanalisation rates

    Defined as a modified Treatment In Cerebral Ischemia (mTICI) scores of 2b50/2b67/2c/3 on the first angiographic run, after the first pass and at the end of the procedure

    Measured: Day 1

  14. Excellent recanalisation rates

    Defined as a modified Treatment In Cerebral Ischemia (mTICI) scores of 2c/3 respectively on the first angiographic run, after the first pass and at the end of the procedure

    Measured: Day 1

  15. Complete recanalisation rates

    Defined as a modified Treatment In Cerebral Ischemia (mTICI) scores of 3 respectively on the first angiographic run, after the first pass and at the end of the procedure

    Measured: Day 1

  16. Adverse events

    Type, frequency and severity of adverse events

    Measured: 3 months

  17. Serious adverse events

    Type, frequency and severity of serious adverse events

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2026
  2. Study start15 Jun 2026 (estimated)
  3. Primary completion1 Jul 2029 (estimated)
  4. Study completion1 Jul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multicenter, controlled, randomized, open trial with blinded evaluation of the primary endpoint (Prospective Open Blinding Endpoint PROBE study).
Masking
None (open label)
Enrolment
486 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07603440
Sponsor's protocol ID
APHP240911
Other IDs
2024-520414-21-00
Acronym
IVT-ALL-IN
Status last verified
May 2026
First submitted
18 May 2026
Last updated
22 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Intravenous administration and MT alone in people with Stroke, run by Assistance Publique - Hôpitaux de Paris at 36 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gaspard GERSCHENFELD, MD, PhD (1 84 82 82 85 ext. +33, gaspard.gerschenfeld@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of good functional outcome (independent ambulation) at 3 months (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07603440.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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