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    Summary
    EudraCT Number:2018-000590-75
    Sponsor's Protocol Code Number:betami_vs_1.0
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-03-06
    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 ConcernedNorway - NOMA
    A.2EudraCT number2018-000590-75
    A.3Full title of the trial
    BEta-Blocker Treatment after Acute Myocardial Infarction in
    revascularized patients with preserved left ventricular systolic function
    (BETAMI trial)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    BETAMI studien: Behandling med eller uten betablokkere hos pasienter
    med hjerteinfarkt
    A.4.1Sponsor's protocol code numberbetami_vs_1.0
    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 SponsorOslo University Hospital
    B.1.3.4CountryNorway
    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 supportOslo University Hospital
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOslo University Hospital
    B.5.2Functional name of contact pointwill be completed during feb18
    B.5.3 Address:
    B.5.3.1Street AddressPostboks 4956 Nydalen
    B.5.3.2Town/ cityOslo
    B.5.3.3Post code0242
    B.5.3.4CountryNorway
    B.5.6E-maillena.gjevert@ous-hf.no
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Metoprolol succinate (trade names: Metoprolol sandoz, Betaloc zok, Selo-zok) Bisoprolol (trade names: bisprolol , emconcor) Carvedilol (trade name: Carvedilol ) Nebivolol (trade name: Hypoloc)
    D.2.1.1.2Name of the Marketing Authorisation holderMerck, Sandoz AS, Farmagon
    D.2.1.2Country which granted the Marketing AuthorisationNorway
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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
    Patients admitted to hospital with acute myocardial infarction treated With reperfusion therapy (i.e trombolysis or percutaneous coronary intervention)
    E.1.1.1Medical condition in easily understood language
    The study aims to investigate whether oral betablocker (BB) therapy is superior to no such treatment following an acute myocardial infarction (AMI).
    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
    The primary objective is to test whether oral BB therapy reduces the risk of all-cause death or non-fatal MI compared to no such therapy, in patients with AMI treated with PCI or thrombolysis and no clinical signs of heart failure and/or LVEF ≥ 40%.
    E.2.2Secondary objectives of the trial
    The key secondary objectives are:
    • To study whether oral BB therapy reduces the risk of each of the components of the primary end-point separately, compared to no such therapy
    • To study whether oral BB therapy reduces the risk of hospitalization for ventricular arrhythmias or heart failure compared to no such therapy
    • To study whether oral BB therapy reduces the risk of cardiovascular death compared to no such therapy
    • To conduct a health economic evaluation including drug use, health care utilization, employment, income, and benefit take-up
    • To compare sociodemographic, clinical, and psychosocial characteristics between the two study arms
    • To assess study safety
    • To assess efficacy between subgroups
    Post-trial objective:
    • To perform a joint analysis of the data with the REDUCE study (Sweden) and DANBLOCK (Denmark). This analysis will comprise 16500 patients, giving increased power and precision to make clinical decisions on both primary and secondary endpoints.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Exploratory biobanking objectives:
    • To study the proportion and predictors of non-adherence with BB, statins and other cardiovascular drugs assessed by direct methods quantifying drug concentrations in blood
    • Identify pharmacokinetic, pharmacogenetic and direct drug-related markers associated with side-effects and suboptimal response to treatment with cardiovascular drugs
    E.3Principal inclusion criteria
    • 18 years or older
    • Diagnosed with an acute MI type I according to the "Universal Definition of MI" (Defined as a detection of a rise and/or fall of cardiac biomarker value, preferably troponin, with at least one value above the 99th percentile upper reference limit and with at least one of the following; a) symptoms of ischemia, b) new or presumed new significant ST-segment-T wave changes or new left bundle branch block, c) development of pathological Q waves, d) imaging evidence of new loss of viable myocardium or e) identification of an intracoronary thrombus by CAG)
    • Must have been treated with PCI or thrombolysis during current hospitalization
    • Signed informed consent and expected cooperation of the patient according to ICH/GCP and national/local regulations
    • Have a national personal identification number and not be expected to emigrate during study
    E.4Principal exclusion criteria
    Study subjects must not meet any of the following criteria:
    • Having a condition where BB-therapy is required, including but not limited to:
    o Arrhythmias
    o Hypertension
    o Cardiomyopathies
    o Clinical diagnosis of heart failure
    o LVEF < 40% by echocardiography
    • Contraindications to BB-therapy:
    o Bradyarrhythmias
    o Hypotension
    o Severe peripheral artery disease
    o Previously known side-effects causing withdrawal
    o Severe chronic obstructive pulmonary disease
    o Others, according to the responsible investigator
    • Any condition (e.g. psychiatric illness, dementia) or situation, that in the investigators opinion could put the subject at significant risk, confound the study results, interfere significantly with the subject participation in the study, or rendering informed consent unfeasible
    • Women of childbearing potential using inadequate birth control, pregnancy, and/or breastfeeding. Adequate contraception includes oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device or system, vasectomized partner or sexual abstinence.
    • Short life expectancy due to other medical conditions
    Previous treatment with a BB is not an exclusion criterion for enrollment into the BETAMI study.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint:
    • Time to all-cause mortality or non-fatal MI
    E.5.1.1Timepoint(s) of evaluation of this end point
    At study end after estimated 0.5-6.5 years for each patient
    E.5.2Secondary end point(s)
    Secondary endpoints:
    • Time to non-fatal MI, all-cause mortality, ventricular arrhythmias, hospitalization for heart failure, cardiovascular death
    • Income, employment status, drug use, health care utilization, and benefit take-up
    • Traditional cardiovascular risk factors, drug adherence, and self-reported side-effects
    Safety endpoint:
    • Rate of ventricular arrhythmias, heart failure, new MI or all-cause death 30 days after randomization
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary end-points: At study end after estimated 0.5-6.5 years for each patient
    Safety end-Points: Safety endpoints will be collected by direct telephone contact with the patient at 30 day after randomization
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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 No
    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
    The comparator is "no treatment" (i.e. no betablocker therapy)
    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 concerned30
    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
    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
    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: 2500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2500
    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 state5000
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 5000
    F.4.2.2In the whole clinical trial 5000
    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 subject has ended the participation in the trial treatment With betablocker therapy will be left to the descretion of the treating physician. However, the study results of this trial together With two similar ongoing trials (REDUCE in Sweeden) (DANBLOCK in Denmark) will guide furher clinical practice with betablocker therapy for this patient Group.
    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 Decision2018-05-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-15
    P. End of Trial
    P.End of Trial StatusOngoing
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