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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) (IVT-ALL-IN)

2026년 5월 18일 업데이트: Assistance Publique - Hôpitaux de Paris

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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

486

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 프랑스
      • Aix-en-Provence, 프랑스, 13100
        • CH Pays d'Aix - Site d'Aix-en-Provence
        • 수석 연구원:
          • Silvia DI EGGE
      • Besançon, 프랑스, 25030
        • CHU Besançon
        • 수석 연구원:
          • Guillaume CHARBONNIER
      • Bordeaux, 프랑스, 33076
        • CHU Bordeaux - Groupe Hospitalier Pellegrin
        • 수석 연구원:
          • Igor SIBON
      • Brest, 프랑스, 29609
        • CHU Brest - Hôpital de la Cavale Blanche
        • 수석 연구원:
          • Serge TIMSIT
      • Bron, 프랑스, 69500
        • HCL - Hôpital Pierre Wertheimer
        • 수석 연구원:
          • Tae-Hee CHO
      • Caen, 프랑스, 14000
        • CHU Caen Normandie
        • 수석 연구원:
          • Marion BOULANGER
      • Corbeil-Essonnes, 프랑스, 91106
        • CH Sud Francilien
        • 수석 연구원:
          • Nicolas CHAUSSON
      • Créteil, 프랑스, 94000
        • AP-HP - Hôpital Henri Mondor-Albert Chenevier
        • 수석 연구원:
          • Aymeric WITTWER
      • Dijon, 프랑스, 21079
        • CHU Dijon Bourgogne
        • 수석 연구원:
          • Yannick BEJOT
      • Gonesse, 프랑스, 95500
        • CH Gonesse
        • 수석 연구원:
          • Eric MANCHON
      • Grenoble, 프랑스, 38043
        • CHU Grenoble Alpes - Site Nord
        • 수석 연구원:
          • Olivier DETANTE
      • Le Chesnay, 프랑스, 78000
        • CH Versailles - Hôpital André Mignot
        • 수석 연구원:
          • Fernando PICO
      • Le Kremlin-Bicêtre, 프랑스, 94275
        • AP-HP - Hôpital Bicêtre
        • 수석 연구원:
          • Laura VENDITTI
      • Lille, 프랑스, 59000
        • CHU Lille - Hôpital Roger Salengro
        • 수석 연구원:
          • Lucie DELLA SCHIAVA
      • Limoges, 프랑스, 87042
        • CHU Limoges - Hopital Dupuytren
        • 수석 연구원:
          • Francisco MACIAN-MONTORO
      • Marseille, 프랑스, 13005
        • AP-HM - Hôpital de la Timone
        • 수석 연구원:
          • Laurent SUISSA
      • Montpellier, 프랑스, 34295
        • CHU Montpellier - Hôpital Saint-Eloi
        • 수석 연구원:
          • Caroline ARQUIZAN
      • Nancy, 프랑스, 54035
        • CHRU Nancy - Hôpital Central
        • 수석 연구원:
          • Sébastien RICHARD
      • Nantes, 프랑스, 44093
        • CHU Nantes - Hopital Nord Laënnec
        • 수석 연구원:
          • Benoit GUILLON
      • Nice, 프랑스, 6000
        • CHU Nice - Hôpital Pasteur
        • 수석 연구원:
          • Barbara CASOLLA
      • Paris, 프랑스, 75019
        • Fondation Adolphe de Rothschild
        • 수석 연구원:
          • Michael OBADIA
      • Paris, 프랑스, 75013
        • Hôpital Pitié-Salpêtrière
        • 수석 연구원:
          • Gaspard GERSCHENFELD
      • Paris, 프랑스, 75018
        • AP-HP - Hôpital Bichat
        • 수석 연구원:
          • Philippa LAVALLEE
      • Paris, 프랑스, 75010
        • AP-HP - Hôpital Lariboisiere-Fernand Widal
        • 수석 연구원:
          • Elodie BERTHET
      • Paris, 프랑스, 75014
        • GH Paris Saint-Joseph - Hôpital Paris Saint-Joseph
        • 수석 연구원:
          • Benjamin MAYER
      • Paris, 프랑스, 75014
        • GHU Paris Psychiatrie et Neurosciences - Hôpital Sainte-Anne
        • 수석 연구원:
          • Guillaume TURC
      • Perpignan, 프랑스, 66046
        • CH Perpignan
        • 수석 연구원:
          • Denis SABLOT
      • Poitiers, 프랑스, 86000
        • CHU Poitiers - Hôpital de La Milétrie
      • Reims, 프랑스, 51100
        • CHU Reims - Hôpital Maison Blanche
        • 수석 연구원:
          • Solène MOULIN
      • Rennes, 프랑스, 35033
        • CHU Rennes - Hopital Pontchaillou
        • 수석 연구원:
          • Stéphane VANNIER
      • Rouen, 프랑스, 76031
        • CHU Rouen - Hôpital Charles-Nicolle
        • 수석 연구원:
          • Florian BASILLE
      • Saint-Denis, 프랑스, 93200
        • CH Saint-Denis - Hôpital Delafontaine
        • 수석 연구원:
          • Carole HENRY
      • Saint-Etienne, 프랑스, 42055
        • CHU Saint-Etienne - Hôpital Nord
        • 수석 연구원:
          • Pierre GARNIER
      • Strasbourg, 프랑스, 67098
        • Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
        • 수석 연구원:
          • Valérie WOLFF
      • Suresnes, 프랑스, 92150
        • Hôpital Foch
        • 수석 연구원:
          • Bertrand LAPERGUE
      • Tours, 프랑스, 37000
        • CHRU Tours - Hôpital Bretonneau
        • 수석 연구원:
          • Marco PASI

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion criteria :

  • 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))

Exclusion criteria :

  • 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
      • 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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: IVT with Tenecteplase followed by MT
Intravenous administration of Tenecteplase (0.25 mg/kg, maximum 25 mg) followed by mechanical thrombectomy
의약품: Intravenous administration
Intravenous administration of Tenecteplase (0.25 mg/kg, maximum 25 mg) followed by mechanical thrombectomy (MT)
활성 비교기: Active Comparator: MT alone
Mechanical thrombectomy alone
절차: MT alone
Mechanical thrombectomy alone

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Rate of good functional outcome (independent ambulation) at 3 months
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Early neurological improvement.
기간: D1

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)
D1
3-month functional independence rate
기간: 3 months
Defined as a 3-month mRS score of 0-2
3 months
Distribution of 3-month mRS scores
기간: 3 months
Ordinal analysis 3-month functional outcome
3 months
One-year independent ambulation rate
기간: 1 year
Defined as a 1-year mRS score of 0-3.
1 year
One-year functional independence
기간: 1 year
Defined as a 1-year mRS score of 0-2.
1 year
Mean change in infarct volume from baseline at day 1
기간: Day 1
Defined as (day 1 volume) - (baseline volume).
Day 1
Early neurological worsening.
기간: Day 1
Defined as a ≥ 4-point increase on the NIHSS score within 24 hours due to the stroke itself.
Day 1
Intracerebral hemorrhage.
기간: Day 2
Intracerebral hemorrhage defined according to the Heidelberg Bleeding Classification.
Day 2
Symptomatic intracerebral hemorrhage.
기간: Day 2
Symptomatic intracerebral hemorrhage defined according to the Heidelberg Bleeding Classification.
Day 2
3-month mortality rate.
기간: 3 months
All-cause mortality.
3 months
1-year mortality rate.
기간: 1 year
All-cause mortality.
1 year
Medico-economic study.
기간: 1 year
Incremental cost utility ratio analysis.
1 year
Successful recanalisation rates
기간: Day 1
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
Day 1
Excellent recanalisation rates
기간: Day 1
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
Day 1
Complete recanalisation rates
기간: Day 1
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
Day 1
Adverse events
기간: 3 months
Type, frequency and severity of adverse events
3 months
Serious adverse events
기간: 3 months
Type, frequency and severity of serious adverse events
3 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Assistance Publique - Hôpitaux de Paris

수사관

  • 연구 책임자: Gaspard GERSCHENFELD, MD, PhD, APHP

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 6월 15일

기본 완료 (추정된)

2029년 7월 1일

연구 완료 (추정된)

2029년 7월 1일

연구 등록 날짜

최초 제출

2026년 5월 18일

QC 기준을 충족하는 최초 제출

2026년 5월 18일

처음 게시됨 (실제)

2026년 5월 22일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 22일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 18일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • APHP240911
  • 2024-520414-21-00 (씨티스)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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.

IPD 공유 기간

Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor

IPD 공유 액세스 기준

Researchers who provide a methodologically sound proposal.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

뇌졸중에 대한 임상 시험

Intravenous administration에 대한 임상 시험

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건강 상태

약물 개입

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CROs in Germany

정황

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약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다