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    Summary
    EudraCT Number:2020-001599-13
    Sponsor's Protocol Code Number:TNKCAT
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-08-13
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2020-001599-13
    A.3Full title of the trial
    Tenecteplase Compared to Alteplase for Large Vesel Oclusion patients before Thrombectomy
    Tenecteplasa en comparación con Alteplasa para pacientes con oclusión de gran vaso antes de la trombectomía.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Tenecteplase Compared to Alteplase for Large Vesel Oclusion patients before Thrombectomy
    Tenecteplasa en comparación con Alteplasa para pacientes con oclusión de gran vaso antes de la trombectomía.
    A.3.2Name or abbreviated title of the trial where available
    TNKCAT Trial
    Ensayo TNKCAT
    A.4.1Sponsor's protocol code numberTNKCAT
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorHospital Vall Hebron
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportHospital Vall Hebron
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Vall Hebron
    B.5.2Functional name of contact pointEstela Sanjuan
    B.5.3 Address:
    B.5.3.1Street AddressPasseig Vall Hebron 119-129
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08035
    B.5.3.4CountrySpain
    B.5.4Telephone number00349348930006326
    B.5.6E-mailensayosictus@gmail.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Metalyse
    D.2.1.1.2Name of the Marketing Authorisation holderBoeringher Ingelheim Pty Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTenecteplase
    D.3.2Product code NA
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Actilyse
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim Pty Ltd
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAlteplase
    D.3.2Product code NA
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    Intravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute Ischaemic Stroke
    Ictus Isquémico Agudo
    E.1.1.1Medical condition in easily understood language
    Acute Ischaemic Stroke
    Ictus Isquémico Agudo
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of the present study is to determine the safety and efficacy of TNK (0.25mh/kg) compared to tPA (0.9 mg/kg) in LVO patients candidates for EVT in both Mothership and Drip-and-Ship scenarios.
    El objetivo del presente estudio es determinar la seguridad y la eficacia de TNK (0.25mg / kg) en comparación con tPA (0.9 mg / kg) en pacientes con OGV candidatos a TEV en los escenarios Mothership y Drip-and-Ship
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients eligible to undergo intravenous thrombolysis (tPA or TNK) within 4.5 hours after the onset of ischemic stroke.
    • Cerebral vascular occlusion on CT angiography of the intracranial ICA, MCA M1 or MCA M2 and if EVT could start (arterial puncture) within 6 hours after stroke onset.
    • Age >18 y.o
    • Men and women (women with child-bearing potential are excluded).
    • A new focal disabling neurologic deficit consistent with acute cerebral ischemia.
    • Informed consent obtained from subject or acceptable subject surrogate (i.e. next of kin, or legal representative), or Differed Inform Consent (DIC) to avoid any delay in the initiation of iv thrombolysis. The DIC will be sign by the patient or next of kin at any time after the tPA or TNK treatment is started.
    Pacientes elegibles para someterse a trombólisis endovenosa (tPA o TNK) dentro de las 4.5 horas posteriores al inicio del ictus isquémico.
    • Oclusión vascular cerebral en la angiografía por TC de la arteria cerebral media (M1 o M2) o la arteria carótida interna (ACI intracraneal), y si la TEV (punción arterial) puede comenzar dentro de las 6 horas posteriores al inicio de los síntomas.
    • Edad >18 años.
    • Un nuevo déficit neurológico discapacitante focal compatible con isquemia cerebral aguda.
    • Consentimiento informado obtenido del sujeto o representante legal/allegado, o consentimiento informado diferido (DIC) para evitar demoras en el inicio de la trombólisis endovenosa. La DIC será firmada por el paciente o sus familiares en cualquier momento después de que se inicie el tratamiento con tPA o TNK.
    E.4Principal exclusion criteria
    • Patients with severe preexisting disability, defined as a modified Rankin scale score >3.
    • Glasgow Coma Scale score ≤ 7.
    • Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR >3.0.
    • Baseline platelet count <50,000/μL.
    • Baseline blood glucose of <50 mg/dL or >400 mg/dL.
    • Severe, sustained and uncontrollable hypertension (systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg).
    • Serious, advanced, or terminal illness with anticipated life expectancy of less than 3 months.
    • Patients that are unlikely to be available for a 90-day follow-up (e.g. no fixed home address, visitor from overseas).
    • Patient participating in a study involving an investigational drug or device that would impact this study.
    • Suspicion of aortic dissection presumed septic embolus, or suspicion of bacterial endocarditis.
    Pacientes con discapacidad preexistente grave, definida como una puntuación de la escala de Rankin modificada (mRs) ≥ 3.
    • Puntación de la escala de coma de Glasgow (GCS) ≤ 7.
    • Diátesis hemorrágica conocida, deficiencia del factor de coagulación o terapia anticoagulante oral con INR> 3.0.
    • Recuento basal de plaquetas <50,000 / μL.
    • Glucemia basal de <50 mg / dL o> 400 mg / dL.
    • Hipertensión severa, sostenida e incontrolable (presión arterial sistólica> 185 mmHg o presión arterial diastólica> 110 mmHg).
    • Enfermedad grave, avanzada o terminal con una expectativa de vida de menos de 3 meses.
    • Pacientes no disponibles para un seguimiento de 3 meses (por ejemplo, sin domicilio fijo, visitante del extranjero).
    • Paciente que participa en un estudio que involucra un medicamento o dispositivo en investigación que impactaría en este estudio.
    • Sospecha de disección aórtica presunta embolia séptica, o sospecha de endocarditis bacteriana.
    • Embarazo (mujeres en edad fértil se deberá excluir un potencial embarazo mediante test).
    E.5 End points
    E.5.1Primary end point(s)
    Shift analysis of the modified Rankin scale score at 3 months
    Puntuación en la escala mRs a los 3 meses mediante un shift analisis
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months
    3 meses
    E.5.2Secondary end point(s)
    - Rates of mRS 0-2 at 3 months
    - Rates of pre-interventional recanalization
    - Dramatic clinical recovery before EVT (Improvement in > 8 point in the NIHSS jscore or NIHSS score < 2 before groin puncture)
    - Rates of first pass TICI 3, final TICI 2b-3
    - Rates of distal embolization during EVT
    - Differences in needle-to-groin times in Mothership patients and in DIDO times in Drip-and-Ship patients.
    - Differences in time metrics between TNKCAT and non-TNKCAT centers
    - Differences in final infarct volume on follow up CT
    - Tasas de mRS 0-2 a los 3 meses
    - Tasas de recanalización pre-intervencionismo
    - Recuperación clínica dramática antes de la TEV (Mejora en> 8 puntos en la puntuación de la escala NIHSS o bien NIHSS <2 antes de la punción de la ingle)
    - Tasas de primer pase TICI 3, final TICI 2b-3
    - Tasas de embolización distal durante TEV
    - Diferencias en los tiempos de puerta-aguja y puerta-ingle en pacientes de Mothership y en tiempos de door-in-door-out (DIDO) en pacientes de Drip-and-Ship.
    - Diferencias en las métricas de tiempo entre centros TNKCAT y no TNKCAT
    - Diferencias en el volumen final del infarto en la tomografía computerizada (TC) craneal de seguimiento
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 months and at baseline
    3 meses y al basal
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state500
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Ninguno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-08-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-26
    P. End of Trial
    P.End of Trial StatusOngoing
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