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    The EU Clinical Trials Register currently displays   38003   clinical trials with a EudraCT protocol, of which   6235   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2011-000911-26
    Sponsor's Protocol Code Number:Uni-Koeln-1392
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-04-13
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2011-000911-26
    A.3Full title of the trial
    Heart rate control after acute myocardial infarct
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Heart rate control after acute myocardial infarct
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberUni-Koeln-1392
    A.5.4Other Identifiers
    Name:DRKS numberNumber:DKRS00000766
    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 of Cologne
    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 supportBaxter Healthcare Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Cologne
    B.5.2Functional name of contact pointPriv.-Doz. Dr. Er
    B.5.3 Address:
    B.5.3.1Street AddressKerpener Str. 62
    B.5.3.2Town/ cityCologne
    B.5.3.3Post code50937
    B.5.4Telephone number+49221478 32544
    B.5.5Fax number+49221478 32712
    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. name Brevibloc
    D. of the Marketing Authorisation holderBaxter Deutschland GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 81161-17-3
    D.3.9.2Current sponsor codeEsmololhydrochlorid
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInfusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    successful percutaneous intervention in patients with acute ST-elevated myocardial infarct
    E.1.1.1Medical condition in easily understood language
    successful dilatation of heart vessels after acute ST-elevated myocardial infarct
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    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
    Maximal increase of Troponin T concentration over 48 hours after the baseline value
    E.2.2Secondary objectives of the trial
    • Endothelial Progenitor cells (EPC)
    • NT-proBNP
    • Re-incidence of Angina Pectoris
    • Re-hospitalisation
    • Re-heart catheter
    • Re-myocardial infarction
    • Re-intervention
    • overall mortality
    • LVEF (transthorakal echokardiography)
    • Neuropsychological status (VAS)
    • Quality of life (on basis of EQ5-D questionnaire)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Acute st-segment elevation myocardial infarction (time between symptom onset and PCI < 6 hours) with successful PCI (TIMI III°)
    • Killip Klassification I, II
    • Written informed consent
    • Resting heart rate ≥ 60 bpm
    • Age above 18 years
    • Mean blood pressure ≥ 65 mmHg
    • Systolic blood pressure > 90mmHg
    • Medication with Heparin (weight adapted), clopidogrel ans aspirin before PCI
    • SO2 > 90%
    • Elevated heart rate (≥ 60/min)
    E.4Principal exclusion criteria
    • Mean blood pressure < 65 mmHg
    • Incomplete PCI success (TIMI < III)
    • Cardiogenic shock
    • Killip Klassification III, IV
    • Symptomatic AV conduction block II°, III°
    • Catecholamin therapy
    • Heart rate < 60/min.
    • Severe peripheral artery disease (Fontaine > IIb)
    • Moderate to severe renal impairment (Serum-creatinin > 2 mg/100ml)
    • Severe liver dysfunction
    • Severe acidosis (pH < 7,2)
    • Known contraindications for Brevibloc (e.g. asthma bronchiale) or known intolerance to Brevibloc
    • Participation in other interventional studies
    • Person related to the sponsor or investigator
    • Unterbringung in einer Anstalt aufgrund gerichtlicher oder behördlicher Anordnung
    • Subjects who were not eligible for follow-up visits (e.g. due to long distance between study hospital and home adress)
    • Women in whom a pregnancy cannot excluded
    • Missing safe contraception (hormonal or copper spirale)
    • Patients without guidelines recommended therapy previosly to PCI
    • Patients in whom anamnestic the symptom onset was > 6 hours or first laboratory tests indicate (LDH > 280U/I) that the myocardial infarction onset was more than 6 hours and in whom no other reasons for elevated LDH are present.
    • Unsuccessful PCI
    • Symptom onset > 6 hours
    E.5 End points
    E.5.1Primary end point(s)
    Maximal increase of the Troponin-T-concentration over 48 h after baseline value.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The Troponin values will be determined 1, 6, 12, 24 and 48 hours post AMI.
    E.5.2Secondary end point(s)
    • Endothelial Progenitor cells (EPC)
    • NT-proBNP
    • Re-incidence of Angina Pectoris
    • Re-hospitalisation
    • Re-heart catheter
    • Re-myocarial infarct
    • Re-intervention
    • overall mortality
    • LVEF (Transthorakal Echokardiography)
    • Neuropsychological State (VAS)
    • Quality of life (on basis of EQ5-D questionnaire)
    E.5.2.1Timepoint(s) of evaluation of this end point
    All other target parameters will be determined 6 weeks and 6 months after finishing of the patient-individual 24 hours intervention respectively by an blinded investigator. The EPC-determination will be done by a blinded investigator by FACS (Fluorescence Activated Cell Sorting) and the
    NT-proBNP measurements will be done in the central laboratory of the university of Cologne.
    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. 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 No
    E.8.1.3Single blind Yes
    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 Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    End of Trial: last visit of the last subject undergoing the trial.

    The treatment and aftertreatment of the patients with a myocardial infarct will be done concerning the internal guidances of the clinic III internal medicine, which are orientated at the effective guidances of the German and European society of Cardiology.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    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.1.1Number of subjects for this age range: 0
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 Yes
    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 state100
    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)
    The treatment and aftertreatment of the patients with MI will be done concerning the internal guidances of the clinic III for internal medicine which are orientated on the active guidances on the German and European society of cardiology (de Verf et al., EHJ 2008; 29: 2909-2945).
    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 Decision2011-05-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-02-24
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