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    The EU Clinical Trials Register currently displays   37221   clinical trials with a EudraCT protocol, of which   6123   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2016-005086-31
    Sponsor's Protocol Code Number:60258
    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:2017-06-27
    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 number2016-005086-31
    A.3Full title of the trial
    Multicentre Randomised trial of Acute Stroke treatment in the Ambulance with a nitroglycerine Patch
    Multicentrum gerandomiseerde klinische studie naar de behandeling met een nitroglycerine pleister in de ambulance bij patiënten met een herseninfarct of hersenbloeding
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study on the treatment with a nitroglycerin patch in the ambulance for patients with a stroke
    Onderzoek naar de behandeling met een nitroglycerine pleister bij patiënten met een beroerte
    A.3.2Name or abbreviated title of the trial where available
    MR ASAP
    A.4.1Sponsor's protocol code number60258
    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 SponsorUniversity Medical Center Utrecht (UMCU)
    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 supportNetherlands Heart Foundation
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Utrecht
    B.5.2Functional name of contact pointTrial Office Neurology
    B.5.3 Address:
    B.5.3.1Street AddressPO box 85500
    B.5.3.2Town/ cityUtrecht
    B.5.3.3Post code3508 GA
    B.5.3.4CountryNetherlands
    B.5.6E-mailmrasap@amc.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.2.1.2Country 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 namenitroglycerin
    D.3.4Pharmaceutical form Transdermal patch
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTransdermal 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
    Stroke
    E.1.1.1Medical condition in easily understood language
    Stroke
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10042244
    E.1.2Term Stroke
    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
    To assess the effect of transdermal GTN, started within 3 hours of symptom onset in the prehospital setting, on functional outcome at 90 days in patients with acute ischaemic stroke or intracerebral haemorrhage.
    E.2.2Secondary objectives of the trial
    To assess whether the effects of transdermal GTN, started within 3 hours of symptom onset in the prehospital setting, on functional outcome at 90 days are consistent across specific subgroups of patients, i.e., those with 1. ischaemic stroke; 2. ischaemic stroke treated with endovascular techniques; or 3. intracerebral haemorrhage.
    To assess the effect of GTN on collaterals, size of the ischemic core and salvageable brain tissue on admission to the hospital.
    To collect and analyse data regarding the deferred consent procedure and its association with patient recall and satisfaction at three months from randomisation.
    To study the efficiency of national IAT implementation, given the availability of IAT hospitals and capacity, and travel times of ambulance services.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age 18 years or older;
    2. Probable diagnosis of acute stroke, as made by the paramedic in the prehospital setting;
    3. Score of 2 or 3 on the Face Arm Speech Test (FAST);
    4. Systolic blood pressure ≥ 140 mm Hg;
    5. Possibility to start the trial treatment within 3 hours of symptom onset;
    6. Intention to transport the patient to one of the participating hospitals;
    7. Written informed consent (deferred).
    E.4Principal exclusion criteria
    1. Considerable pre-stroke dependency in activities of daily living, defined as staying in a chronic nursing home or rehabilitation centre;
    2. Known glucose < 2.5 mmol/L;
    3. Witnessed seizure at presentation;
    4. Known life expectancy ≤ 1 year;
    5. Known pregnancy or lactation;
    6. Clinical indication for treatment with GTN;
    7. Clinical indication for reduction of blood pressure;
    8. Known hypersensitivity to GTN, nitrates in general, or the adhesives used in the patch
    9. Glasgow Coma Scale < 8;
    10. Known with any of the following heart disorders: myocardial insufficiency due to obstruction; aortic or mitral valve stenosis; constrictive pericarditis; hypertrophic obstructive cardiomyopathy; cardiac tamponade;
    11. Known marked anaemia, defined as haemoglobin < 5 mmol/L;
    12. Known closed angle glaucoma;
    13. Known concomitant use of phosphodiesterase type-5 inhibitors, (e.g. sildenafil, tadalafil, vardenafil) or the soluble guanylate cyclase stimulator riociguat.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure is the score on the modified Rankin Scale (mRS)54 at 90 days (± 14 days). The mRS is the preferred disability parameter for 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)
    On admission to the hospital:
     Vital signs: first measured systolic and diastolic blood pressure, pulse, and body temperature;
     Collateral circulation, as assessed with CTA (only in patients in whom CT angiography is performed as part of routine clinical care);
     Lesion size: volume of the perfusion deficit (only in patients in whom CT perfusion is performed as part of routine clinical care) or ICH on the initial CT;

    At 24 hours (± 4 hours):
     Treatment with intravenous thrombolysis;
     Intra-arterial treatment;
     Vital signs: systolic and diastolic blood pressure, pulse, and body temperature;
     Neurological deficit, as assessed with the NIHSS;

    At 7 days (± 1 day) or at discharge, if earlier:
     SAEs in the first 7 days or until discharge, if earlier;

    At 90 days (± 14 days):
     Death;
     Dichotomized mRS of 0-1 vs. 2-6;
     Dichotomized mRS of 0-2 vs. 3-6;
     Dichotomized mRS of 0-3 vs. 4-6;
     Disability assessed with the score on the Barthel Index56 (BI);
     Quality of life assessed with the EuroQol 5D-5L (EQ-5D-5L);
     Home time: the number of nights among the first 90 since stroke onset that are spent in the patient’s own home or a relative’s home. Resource use will be censored at 90 days. Where final follow-up occurs earlier, the last known placement will be extrapolated to 90 days;
     Patient location over first 90 days (± 14 days): hospital; rehabilitation service; chronic nursing facility; home.
    E.5.2.1Timepoint(s) of evaluation of this end point
    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 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
    standard care
    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 concerned3
    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
    Reasons for terminating may include
    The incidence and severity of AEs in this/other studies indicates potential health hazard to subjects
    Subject enrolment unsatisfactory
    Data recording inaccurate/incomplete unacceptable extent
    Investigator(s) do not adhere to the protocol or applicable regulatory guidelines in conducting this study
    Submission of knowingly false information from study site to Sponsor or regulatory authorities
    Results of an interim analysis supporting terminating study
    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 months
    E.8.9.1In the Member State concerned days
    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: 700
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 700
    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 2017-06-27. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    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 state1400
    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
    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 Decision2017-06-27
    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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