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    Summary
    EudraCT Number:2017-002336-17
    Sponsor's Protocol Code Number:REDUCe_2017-05-22
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-06-15
    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 ConcernedSweden - MPA
    A.2EudraCT number2017-002336-17
    A.3Full title of the trial
    Randomized Evaluation of Decreased Usage of betablocCkErs
    after myocardial infarction in the SWEDEHEART registry

    REDUCe SWEDEHEART
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Registrybased randomised study of Betablockers after myocardial infarction (REDUCE SWEDEHEART)
    Registerbaserad randomiserad studie avseende beta-blockad efter akut hjärtinfarkt (REDUCE-SWEDEHEART)
    A.3.2Name or abbreviated title of the trial where available
    REDUCe SWEDEHEART
    A.4.1Sponsor's protocol code numberREDUCe_2017-05-22
    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 SponsorDepartment of Clinical Sciences, Danderyd Hospital, Karolinska Intitutet
    B.1.3.4CountrySweden
    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 supportVetenskapsrådet
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKarolinska Institutet
    B.5.2Functional name of contact pointTomas Jernberg
    B.5.3 Address:
    B.5.3.1Street AddressDanderyd Hospital
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post codeSE-18288
    B.5.3.4CountrySweden
    B.5.4Telephone number+460701671474
    B.5.6E-mailtomas.jernberg@sll.se
    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 AuthorisationSweden
    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 IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMetoprolol succinate
    D.3.9.3Other descriptive nameMETOPROLOL SUCCINATE
    D.3.9.4EV Substance CodeSUB03274MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBISOPROLOL
    D.3.9.1CAS number 66722-44-9
    D.3.9.3Other descriptive nameBisoprolol
    D.3.9.4EV Substance CodeSUB13096MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number5
    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
    Long-term treatment with beta-blockers in patients with myocardial infarction and preserved ejection fraction.
    E.1.1.1Medical condition in easily understood language
    Long-term treatment with beta-blockers in patients with myocardial infarction and preserved ejection fraction.
    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
    To determine whether long-term treatment with oral beta-blockade in patients with MI and preserved LV systolic ejection fraction reduces the composite of death of any cause or new MI
    E.2.2Secondary objectives of the trial
    To determine whether long-term treatment with oral beta-blockade in patients with MI and preserved LV systolic ejection fraction reduces:
    -All-cause mortality.
    -Cardiovascular mortality.
    -New MI.
    -Readmission because of atrial fibrillation.
    -Readmission because of heart failure.

    To determine whether long-term treatment with oral beta-blockade in patients with MI and preserved LV systolic ejection fraction influences the risk of readmission to hospital because of:
    -Bradycardia, Av-block II-III, hypotension, syncope or need for pacemaker.
    -Asthma or chronic obstructive pulmonary disease.
    -Stroke.

    To determine whether long-term treatment with oral beta-blockade in patients with MI and preserved LV systolic ejection fraction affects PROMs and Health care costs in patients registered in SEPHIA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Age ≥ 18 years.
    2.Day 1-7 after MI as defined by the universal definition of MI, type 1, included in the SWEDEHEART registry.
    3.Coronary angiography performed during hospitalization.
    4.Obstructive coronary artery disease documented by coronary angiography, i.e. stenosis ≥ 50 %, FFR ≤ 0.80 or iFR ≤ 0.89 in any segment at any time point before randomization.
    5.Echocardiography performed after the MI showing a normal ejection fraction (EF≥50%).
    6.Written informed consent obtained
    E.4Principal exclusion criteria
    1.Any condition that may influence the patient’s ability to comply with study protocol.
    2.Contraindications for beta-blockade
    3.Indication for beta-blockade other than as secondary prevention according to the treating physician

    Thus, use of oral beta-blockade on admission is not per se an exclusion criterion.
    E.5 End points
    E.5.1Primary end point(s)
    Time to the composite of death of any cause or MI
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time to event
    E.5.2Secondary end point(s)
    a All-cause death
    b Cardiovascular death
    c MI
    d Atrial fibrillation (primary [main] diagnosis)
    e Heart failure (primary [main] diagnosis)
    f Bradycardia, Advanced AV-block, hypotension, syncope or need for pacemaker
    g Asthma or Chronic Obstructive Pulmonary Disease (primary [main] diagnosis)
    h Stroke
    i PROMs: symptoms (angina, dyspnea), functional status (CCS class and NYHA class) and health related quality of life (EQ-5D) after 6-10 weeks and after 1 year of treatment. Health related quality of life (HRQOL) measured by EQ-5D in patients younger than 75 years of age.
    Health care costs
    E.5.2.1Timepoint(s) of evaluation of this end point
    a-c Time to event
    d-h Time to admission to hospital
    i After 6-10 weeks and after 1 year of treatment.
    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 No
    E.6.5Efficacy No
    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 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
    No beta-blockade
    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 concerned50
    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
    This study is event driven, follow-up will continue until 944 primary endpoints have been observed.
    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 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: 3500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3500
    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 state7000
    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 discontinuation of the study, the patient may receive treatment at the discretion of the treating physician.
    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 Decision2017-08-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-08
    P. End of Trial
    P.End of Trial StatusOngoing
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