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    Summary
    EudraCT Number:2017-001466-21
    Sponsor's Protocol Code Number:61364
    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:2017-08-09
    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 number2017-001466-21
    A.3Full title of the trial
    Multicenter Randomized CLinical trial of Endovascular treatment for Acute ischemic stroke in the Netherlands. The effect of periprocedural MEDication: heparin, antiplatelet agents, both or neither.
    Multicentrum gerandomiseerd klinisch onderzoek van de endovasculaire behandeling van het acute herseninfarct in Nederland: Het effect van periprocedurele medicatie: heparine, plaatjesaggregatie remmers, beide of geen van beide.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multicenter Randomized CLinical trial of Endovascular treatment for Acute ischemic stroke in the Netherlands. The effect of periprocedural MEDication: heparin, antiplatelet agents, both or neither.
    Multicentrum gerandomiseerd klinisch onderzoek van de endovasculaire behandeling van het acute herseninfarct in Nederland: Het effect van periprocedurele medicatie: heparine, plaatjesaggregatie remmers, beide of geen van beide.
    A.3.2Name or abbreviated title of the trial where available
    MR CLEAN - MED
    MR CLEAN - MED
    A.4.1Sponsor's protocol code number61364
    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 University Medical Center
    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 supportDutch Heart Foundation
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus MC University Medical Center
    B.5.2Functional name of contact pointDWJ Dippel, neurologist
    B.5.3 Address:
    B.5.3.1Street Addresswytemaweg 80
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015 CN
    B.5.3.4CountryNetherlands
    B.5.6E-maild.dippel@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 Unfractionated heparin (generic)
    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 nameheparin
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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.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 Aspegic (Acetylsalicylic acid)
    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 nameAspegic
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 stroke
    E.1.1.1Medical condition in easily understood language
    Acute ischemic stroke
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10055221
    E.1.2Term Ischemic stroke
    E.1.2System Organ Class 100000013700
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Objective: To assess the effect of acetylsalicylic acid (ASA) and unfractionated heparin, alone, or in combination, in patients with AIS, who undergo IAT for a confirmed intracranial large vessel occlusion of the anterior circulation.
    E.2.2Secondary objectives of the trial
    The secondary objective is to assess the safety and effect of unfractionated heparin and acetylsalicylic acid, alone, or in combination, on neurological outcome, revascularization and infarct size in patients who undergo intra-arterial treatment for AIS caused by a confirmed intracranial large vessel occlusion of the anterior circulation.

    The tertiary objectives are 1) to collect (waste) biomaterials and to analyze biofactors in blood samples with respect to their potential for treatment effect modification, 2) to collect and analyze data regarding the deferred consent procedure and its association with patient recall and satisfaction at three months from randomization, and 3) to study the efficiency of national IAT implementation. To this end, we aim to collect data (time delays and diagnostics) from each step in the acute stroke pathway as input parameters for a simulation model. This way we can study the regional set-up of the IAT organizational model.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - a clinical diagnosis of acute ischemic stroke;
    - caused by intracranial large vessel occlusion of the anterior circulation (distal intracranial carotid artery or middle (M1/proximal M2) cerebral artery confirmed by neuro-imaging (CTA or MRA);
    - CT or MRI ruling out intracranial hemorrhage;
    - treatment possible (groin puncture) within 6 hours from symptom onset or last seen well;
    - a score of at least 2 on the NIH Stroke Scale;
    - age of 18 years or older;
    - written informed consent (deferred).
    E.4Principal exclusion criteria
    - Pre-stroke disability which interferes with the assessment of functional outcome at 90 days, i.e. mRS >2
    - Contra-indications for ASA/unfractionated heparin, for instance: allergy, recent surgery, heparin induced thrombocytopenia.
    - INR exceeding 3.0
    - Thrombocyte count <1009/L
    - Treatment with IV alteplase despite the following contra-indications for IV alteplase:
    o cerebral infarction in the previous 6 weeks with residual neurological deficit or signs of recent infarction on neuroimaging,
    o previous intracerebral hemorrhage within the previous 3 months,
    o INR exceeding 1.7,
    o prior use of direct oral anticoagulant (DOAC),
    o IV alteplase infusion >4.5 hours after symptom onset.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is the score on the modified Rankin Scale (mRS) at 90 days (± 14 days).30 The mRS is the preferred disability parameter of clinical trials in stroke. The mRS is an ordinal hierarchical scale incorporating six categories from 0 up to and including 5, and describes the range of disability encountered post stroke. ‘Death’ is assigned a score of 6.
    E.5.1.1Timepoint(s) of evaluation of this end point
    90 days
    E.5.2Secondary end point(s)
    Secondary outcomes are the following:
    - Extended treatment in cerebral ischaemia (eTICI) score on final angiography of IAT (Table 2)
    - Recanalization rate at 24 hours, assessed with CTA
    - Score on the NIHSS at 24 hours and 5-7 days, or at discharge
    - Final infarct volume at 5-7 days, assessed with NCCT or MRI in a subset of 600 patients. Final infarct volume will be assessed with the use of an automated, validated algorithm. Infarct size at day 5-7 will be compared with plain CT and perfusion CT results (if available) at baseline.
    - Dichotomized mRS of 0-1 vs. 2-6 at 90 days (± 14 days)
    - Dichotomized mRS of 0-2 vs. 3-6 at 90 days (± 14 days)
    - Dichotomized mRS of 0-3 vs. 4-6 at 90 days (± 14 days)
    - Score on the EQ-5D-5L and Barthel index at 90 days (± 14 days)

    Safety endpoints are the following:
    - Intracerebral hemorrhage according to the Heidelberg Bleeding Classification
    - Symptomatic intracerebral hemorrhage (sICH) scored according to the Heidelberg Bleeding Classification, with the addition of sICH that led to death and that was identified as the predominant cause of the neurologic deterioration
    - Extracranial hemorrhages requiring transfusion or resulting in death
    - Embolization in new territory on angiography during IAT
    - Infarction in new territory within 5-7 days
    - Death from all causes within 90 days (+14 days)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Mostly at 90 days
    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 No
    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 Yes
    E.8.1.7.1Other trial design description
    PROBE design
    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
    Standard care
    E.8.2.4Number of treatment arms in the trial6
    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 concerned4
    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 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
    LVLS and
    The study will only be terminated prematurely if the Data Safety Monitoring Board recommends stopping. In case of premature termination of the study the database will be closed after 90 days assessment of the last enrolled patient and results will be reported
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    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: 750
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 750
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2017-08-09. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Stroke patients may have cognitive problems or aphasia due to their
    stroke, which prevents them from understanding benefits and risks of
    this trial. If those patients would be excluded, the results cannot be
    extrapolated to all stroke patients.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state1500
    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)
    Not different from the expected normal treatment of ischemic stroke
    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 Decision2017-08-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-19
    P. End of Trial
    P.End of Trial StatusOngoing
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