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    The EU Clinical Trials Register currently displays   44236   clinical trials with a EudraCT protocol, of which   7337   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:2016-001642-26
    Sponsor's Protocol Code Number:LRD.2016.STREAM2
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-06-10
    Trial results View 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 ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2016-001642-26
    A.3Full title of the trial
    STREAM-2 (STrategic Reperfusion in elderly patients Early After
    Myocardial Infarction)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    STREAM-2 (STrategic Reperfusion in elderly patients Early After
    Myocardial Infarction)
    A.3.2Name or abbreviated title of the trial where available
    STREAM-2
    A.4.1Sponsor's protocol code numberLRD.2016.STREAM2
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02777580
    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 SponsorLeuven Research & Development (LRD) at University of Leuven, Belgium
    B.1.3.4CountryBelgium
    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 supportBoehringer Ingelheim
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportLife Sciences Research Partners
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportFund for Clinical Cardiovascular Research at LRD
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCONFIDENCE Pharmaceutical Research, LLC
    B.5.2Functional name of contact pointDaniela Pirvu
    B.5.3 Address:
    B.5.3.1Street Address1633 Bayshore Hwy, Suite #328,
    B.5.3.2Town/ cityBurlingame
    B.5.3.3Post code94010
    B.5.3.4CountryUnited States
    B.5.4Telephone number0040729342374
    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 (10000 units)
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim
    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.3.4Pharmaceutical 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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTENECTEPLASE
    D.3.9.1CAS number 191588-94-0
    D.3.9.4EV Substance CodeSUB04718MIG
    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 Yes
    D.3.11.13.1Other medicinal product typerecombinant product, biotechnologically manufactured and isolated from hamster ovarian cells
    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 Clopidogrel Ranbaxy Clopidogrel Ranbaxy 75 mg
    D.2.1.1.2Name of the Marketing Authorisation holderRanbaxy (U.K.) 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.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNClopidogrel
    D.3.9.3Other descriptive nameCLOPIDOGREL
    D.3.9.4EV Substance CodeSUB13395MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75 to 75
    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: 3
    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 (8000 units)
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim
    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.3.4Pharmaceutical 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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTENECTEPLASE
    D.3.9.1CAS number 191588-94-0
    D.3.9.4EV Substance CodeSUB04718MIG
    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 Yes
    D.3.11.13.1Other medicinal product typerecombinant product, biotechnologically manufactured and isolated from hamster ovarian cells
    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
    ST-elevation myocardial infarction within 3 hours of onset of symptoms
    E.1.1.1Medical condition in easily understood language
    ST-elevation myocardial infarction within 3 hours of onset of symptoms
    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 10064345
    E.1.2Term ST segment elevation myocardial infarction
    E.1.2System Organ Class 100000004849
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    In elderly patients ≥ 70yrs with acute ST-elevation myocardial infarction
    randomised within 3 hours of onset of symptoms the efficacy and safety of a
    strategy of early fibrinolytic treatment with half-dose tenecteplase and additional
    antiplatelet therapy with a loading dose of 300 mg clopidogrel, aspirin and coupled
    with antithrombin therapy followed by catheterisation within 6-24 hours or rescue
    coronary intervention as required, will be compared to a strategy of primary PCI
    with a P2Y12 antagonist and antithrombin treatment according to local standards.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age equal or greater than 70 years
    2. Onset of symptoms < 3 hours prior to randomisation
    3. 12-lead ECG indicative of an acute STEMI (ST-elevation will be measured from
    the J point; scale: 1 mm per 0.1 mV):
    ≥ 2 mm ST-elevation across 2 contiguous precordial leads (V1-V6) or leads I
    and aVL for a minimum combined total of ≥ 4 mm ST-elevation
    or
    ≥ 2 mm ST-elevation in 2 contiguous inferior leads (II, III, aVF) for a minimum
    combined total of ≥ 4 mm ST-elevation
    4. Informed consent received
    E.4Principal exclusion criteria
    1. Expected performance of PCI < 60 minutes from diagnosis (qualifying ECG)
    or inability to arrive at the catheterisation laboratory within 3 hours
    2. Previous CABG
    3. Left bundle branch block or ventricular pacing
    4. Patients with cardiogenic shock - Killip Class 4
    5. Patients with a body weight < 55 kg (known or estimated)
    6. Uncontrolled hypertension, defined as sustained blood pressure ≥ 180/110 mm Hg (systolic BP ≥ 180 mm Hg and/or diastolic BP ≥ 110 mm Hg) prior to
    randomisation
    7. Known prior stroke or TIA
    8. Recent administration of any i.v. or s.c. anticoagulation within 12 hours,
    including unfractionated heparin, enoxaparin, and/or bivalirudin or current use
    of oral anticoagulation (i.e. warfarin or a NOACs)
    9. Active bleeding or known bleeding disorder/diathesis
    10. Known history of central nervous system damage (i.e. neoplasm, aneurysm,
    intracranial or spinal surgery) or recent trauma to the head or cranium (i.e. < 3
    months)
    11. Major surgery, biopsy of a parenchymal organ, or significant trauma within the past 2 months (this includes any trauma associated with the current myocardial infarction)
    12. Clinical diagnosis associated with increased risk of bleeding including known
    active peptic ulceration and/or neoplasm with increased bleeding risk
    13. Known severe renal insufficiency
    14. Prolonged cardiopulmonary resuscitation (> 2 minutes) within the past 2 weeks
    15. Known acute pericarditis and/or subacute bacterial endocarditis
    16. Known acute pancreatitis or known severe hepatic dysfunction, including hepatic
    failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis
    17. Dementia
    18. Previous enrolment in this study or treatment with an investigational drug or
    device under another study protocol in the past 7 days
    19. Known allergic reactions to tenecteplase, clopidogrel, enoxaparin and aspirin
    20. Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk if the investigational therapy is initiated
    E.5 End points
    E.5.1Primary end point(s)
    Number of patients achieving ≥ 50 % ST-segment resolution before and
    after PCI in lead with maximal ST elevation at baseline; % rescue PCI;
    TIMI flow grades
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 days post randomisation
    E.5.2Secondary end point(s)
    Clinical events of interest i.e. death, shock, heart failure, recurrent MI
    and aborted MI will be recorded and assessed as single or composite
    endpoints for evaluation as noted in the statistical analytical plan.
    Total stroke, intracranial haemorrhage, ischaemic stroke, haemorrhagic
    conversion.
    Non-intracranial bleeds (total, major, minor, and blood transfusions).
    Serious cardiac events (e.g. death , congestive heart failure, reinfarction,
    resuscitated ventricular fibrillation, repeat target vessel recanalization,
    stent thrombosis, total AV block etc).
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 years 0 months 0 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 No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.1.7.1Other trial design description
    comparative
    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
    Primary PCI according to local standards
    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 concerned18
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Brazil
    Canada
    Chile
    France
    Romania
    Spain
    Norway
    Russian Federation
    Serbia
    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
    End of trial: 30 days after randomisation
    1 year follow-up to obtain vital status/all-cause mortality
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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 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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 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 Yes
    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 state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 600
    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 Decision2018-10-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-02
    P. End of Trial
    P.End of Trial StatusCompleted
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