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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2009-017315-15
    Sponsor's Protocol Code Number:NTR1804
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2010-06-11
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2009-017315-15
    A.3Full title of the trial
    Multi Center Clinical trial of endovascular treatment of acute ischemic stroke in the Netherlands.
    Multi Center Clinical trial of endovascular treatment of acute ischemic stroke in the Netherlands.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multi Center Clinical trial of endovascular treatment of acute ischemic stroke in the Netherlands.
    Klinisch onderzoek naar het effect van endovasculaire behandeling bij patienten met een acuut herseninfarct in Nederland
    A.3.2Name or abbreviated title of the trial where available
    MR CLEAN
    A.4.1Sponsor's protocol code numberNTR1804
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN10888758
    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 SponsorErasmus MC Rotterdam
    B.1.3.4CountryNetherlands
    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 supportErasmus MC
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus MC
    B.5.2Functional name of contact pointMr clean trial office
    B.5.3 Address:
    B.5.3.1Street AddressDr Molenwaterplein 50-60
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015 GE
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31107044206
    B.5.5Fax number+31107044721
    B.5.6E-mailmrclean@erasmusmc.nl
    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 actilyse
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim bv
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 not applicable
    D.3.4Pharmaceutical form Anticoagulant and preservative solution for blood
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPEnteral use (Noncurrent)
    Intraarterial use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNALTEPLASE
    D.3.9.1CAS number 105857-23-6
    D.3.9.2Current sponsor codenot applicable
    D.3.9.3Other descriptive nameactilyse
    D.3.9.4EV Substance CodeSUB05378MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 No
    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 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 medacinase
    D.2.1.1.2Name of the Marketing Authorisation holderMedac
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameurokinase
    D.3.2Product code not applicable
    D.3.4Pharmaceutical form Anticoagulant and preservative solution for blood
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarterial use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmedacinase
    D.3.9.1CAS number 9039-53-6
    D.3.9.2Current sponsor codenot applicable
    D.3.9.3Other descriptive nameUROKINASE
    D.3.9.4EV Substance CodeSUB05055MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400.000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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 ischemic brain infarction
    acuut herseninfarct
    E.1.1.1Medical condition in easily understood language
    Acute brain infarction
    Acuut herseninfarct
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10023027
    E.1.2Term Ischaemic stroke NOS
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to estimate the effect of endovascular treatment on overall functional outcome after acute ischemic stroke of less than six hour duration, in patients with a symptomatic anterior circulation IAO
    E.2.2Secondary objectives of the trial
    . The secondary objectives are to assess the overall safety of endovascular treatment with regard to the occurrence of hemorrhagic and ischemic complications, the efficacy with regard to obtaining recanalization, and to evaluate predictors of recanalization, including imaging aspects and hemostatic parameters. Moreover, we want to assess the safety and efficacy of different types of endovascular treatment (i.e. mechanical treatment, intra-arterial thrombolysis) different combinations of treatment (i.e. with intravenous alteplase) and different timings of treatment
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1. SMARTIS, v1.13, dd March 1st, 2012, objective:assess the relationship between thrombotic and hemostatic markers and neurological outcome in patients with acute ischemic stroke caused by a proximal intracranial arterial occlusion.
    2. THRAPS_v1.10, dd 20-08-2012, objective:describe the thrombus composition in patients with an anterior occlusion in acute ischemic stroke.
    3. MR CLEAN MRI substudy DIANE, version 1.1, 13 november 2012, objective:determine the predictive value of infarct core volume determination with pre-treatment diffusion weighted MRI for clinical outcome in patients with acute ischemic stroke due to proximal large vessel occlusions. To compare infarct volume determination with CT perfusion (CTP) with results from DWI.
    4. CLOT- MR CLEAN Substudy, version 1.1, date 26 february 2013,
    objective:to economically evaluate cerebral endovascular treatment against standard care in patients with a symptomatic occlusion after acute ischemic stroke of less than six hour duration. secondly long term follow-up (2 years) will answer the question whether higher recanalization rates after endovascular treatment improve functional outcome and quality of life.
    E.3Principal inclusion criteria
    *A clinical diagnosis of acute stroke, with a deficit on the NIH stroke scale of more than 2 points.
    • CT or MRI scan ruling out intracranial hemorrhage.
    • Intracranial arterial occlusion of the distal intracranial carotid artery or middle (M1/M2) or anterior (A1/A2) cerebral artery, demonstrated with CTA, MRA, DSA or transcranial Doppler/duplex (TCD).
    • The possibility to start treatment within 6 hours from onset.
    • Informed consent given.
    • Age 18 or over.
    E.4Principal exclusion criteria
    - cerebral infarction in past 6 weeks
    -history in intracerebral bleeding
    -RR > 185/110 unresponsive to antihypertensive agents
    -blood glucose of < 2.7 or > 22.2
    -Clinical signs of hemorrhagic diathesis or platelet count <90 x 10*9/L, APTT>50 sec or INR >1.7
    - intravenous treatment with thrombolysis with a dose exceeding 0.9mg/kg or 90 mg
    -patients who are treated with intravenous thrombolysis while having cantra-indications for it.

    Exclusion criteria for mechanical thrombectomy
    - carotid artery stenosis over 70% (NASCETT) which cannot be stented
    -RR > 185/110
    -Blood glucose < 2.7 or >22.2
    -INR > 3.0 or platelet count < 40 x 10*9
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is the score on the modified Rankin scale 90 days after inclusion in the study
    De primaire uitkomst is de score op de modified rankin scale
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary outcome will be assessed after 90 days
    De primaire uitkomst wordt beoordeeld na 90 dagen
    E.5.2Secondary end point(s)
    Secondary outcome measurements are the NIHSS score, vessel patency, infarct size and occurence of major bleeding.
    Secundaire uitkomstmaten zijn de NIHSS score, recanalisatie, infarct grootte en het optreden van een intracraniele bloeding.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The NIHSS score will be determined at 24 hours
    vessel patency will be determined after 24 hours
    Infarct size will be determined after 5-7 days
    Intracranial hemorrghage will be determined when assessed by CT-brain.
    De NIHSS score wordt bepaald na 24 uur
    Recanalisatie wordt bepaald na 24 uur
    Infarct grootte wordt bepaald na 5-7 dagen
    Intracraniele bloeding wordt bepaald door middel van een CT-hersenen.
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    not applicable
    E.8.2.4Number of treatment arms in the trial3
    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 concerned12
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    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
    The trial will end when 500 patients are included.
    The trial stopt als er 500 patienten geincludeerd zijn.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 250
    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)
    After the patient has ended the participation the medical care will be taken over by the local neurologist or general practitioner
    Als de patient niet meer met de trial meedoet, dan zal de medische zorg worden overgenomen door de eigen behandelend neuroloog voor zover nodig en de huisarts
    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 Decision2010-02-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-06-10
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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