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    Summary
    EudraCT Number:2017-000487-15
    Sponsor's Protocol Code Number:CLSYN.1702
    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:2020-02-12
    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 number2017-000487-15
    A.3Full title of the trial
    CLEAR SYNERGY (OASIS 9)
    A 2x2 factorial randomized controlled trial of CoLchicine and spironolactonE in patients with myocARdial infarction/SYNERGY Stent Registry –
    Organization to Assess Strategies for Ischemic Syndromes 9
    CLEAR SYNERGY (OASIS 9)
    Een 2x2 factorieel gerandomiseerde studie van colchicine en spironolacton in patiënten met myocardinfarct/SYNERGY stent registratie studie - Bepalen van strategieën om ischemische syndromen te behandelen.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of colchicine and spironolactone in patients who have had a heart attack.
    Een studie van colchicine en spironolactone bij patiënten die een hartaanval hebben gehad.
    A.3.2Name or abbreviated title of the trial where available
    CLEAR SYNERGY (OASIS 9)
    A.4.1Sponsor's protocol code numberCLSYN.1702
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03048825
    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 SponsorHamilton Health Sciences Corporation through its Population Health Research Institute
    B.1.3.4CountryCanada
    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 supportCanadian Institutes of Health Research
    B.4.2CountryCanada
    B.4.1Name of organisation providing supportBoston Scientific Corporation
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportPopulation Health Research Institute
    B.4.2CountryCanada
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPopulation Health Research Institute
    B.5.2Functional name of contact pointCLEAR SYNERGY Project Office
    B.5.3 Address:
    B.5.3.1Street Address237 Barton Street East
    B.5.3.2Town/ cityHamilton
    B.5.3.3Post codeL8L 2X2
    B.5.3.4CountryCanada
    B.5.4Telephone number19055274322 xt. 40513
    B.5.6E-mailclear@phri.ca
    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 No
    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 namespironolactone
    D.3.4Pharmaceutical form 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 INNSPIRONOLACTONE
    D.3.9.1CAS number 52-01-7
    D.3.9.4EV Substance CodeSUB10631MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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: 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 colchicine
    D.2.1.1.2Name of the Marketing Authorisation holderTioFarma, B.V
    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 namecolchicine
    D.3.4Pharmaceutical form 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 INNCOLCHICINE
    D.3.9.1CAS number 64-86-8
    D.3.9.3Other descriptive nameCOLCHICINE
    D.3.9.4EV Substance CodeSUB01420MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    ST segment Elevation Myocardial Infarction (STEMI) and Non-ST segment Elevation Myocardial Infarction (NSTEMI)
    E.1.1.1Medical condition in easily understood language
    heart attack
    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
    In patients with MI who have undergone PCI, the primary objectives of this study is to determine:
    1. If colchicine can reduce the incidence of cardiovascular (CV) death, myocardial infarction (MI), or stroke over duration of follow-up.
    2. If spironolactone can reduce the incidence of CV death or new or worsening heart failure over duration of follow-up.
    3. The rate of major adverse cardiac events (MACE) in patients who have received a SYNERGY everolimus-eluting stent compared to performance goal.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. a) Patients with STEMI referred for PCI within 12 hours of symptom onset, have a culprit lesion amenable to
    stenting, and with planned SYNERGY stent implantation for SYNERGY registry

    OR

    b) Patients with STEMI referred for PCI within 48 hours of symptom onset, not prospectively enrolled in SYNERGY
    STENT registry.

    OR

    c) Patients with diagnosis of Non STEMI with ischemic symptoms and either Hs Troponin > or = 200x ULN or Troponin > or = 100x ULN who have undergone PCI with one of the following:

    i. LVEF< or =45%
    ii. Diabetes
    iii. Multivessel CAD defined as 50% stenosis in 2nd major epicardial vessel
    iv. Prior MI
    v. Age >60 years

    2. Able to be enrolled/randomized within 72 hours of index PCI and during initial hospitalization (however patients should be
    randomized as soon as possible after PCI)

    3. Written informed consent
    E.4Principal exclusion criteria
    1. Age ≤18 years
    2. Pregnancy, breastfeeding, or women of childbearing potential who are not using an effective method of contraception
    3. Any medical, geographic, or social factor making study participation impractical or precluding required follow-up
    4. Systolic blood pressure <90 mm Hg
    5. Active diarrhea
    6. Known allergy or contraindication to everolimus, the Synergy stent or any of its components
    7. Unable to receive dual antiplatelet therapy
    8. Any contraindication or known intolerance to colchicine or spironolactone
    9. Requirement of colchicine or mineralocorticoid antagonist for another indication
    10. History of cirrhosis or current severe hepatic disease
    11. Current or planned use of any of: cyclosporine, verapamil, HIV protease inhibitors, azole antifungals, or macrolide antibiotics
    12. Creatinine clearance <30 ml/min/1.73m2
    13. Serum Potassium >5.0 mew/L
    E.5 End points
    E.5.1Primary end point(s)
    In patients with STEMI who have undergone PCI, the primary objectives of this study is to determine:

    1. Colchicine vs. placebo: time to event of the first occurrence of the composite of CV death, recurrent MI, or stroke over duration of follow-up.

    2. Spironolactone vs. placebo: time to event of the first occurrence of the composite of CV death or new or worsening heart failure over duration of follow-up.

    3. SYNERGY stent: MACE (defined as the composite of CV death, recurrent MI, or unplanned ischemia driven target vessel revascularization) for SYNERGY stent compared to a historical performance goal within 1 year
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time-to-event over duration of follow-up. Minimum follow-up of 1 year to maximum of 5 years (average of 2 years).
    E.5.2Secondary end point(s)
    1. COLCHINE VS. COLCHICINE-PLACEBO: Time-to-event of the first occurrence of the composite of cardiovascular death, recurrent MI,
    unplanned ischemia driven revascularization, or stroke, over the duration of follow-up.

    2. SPIRONOLACTONE VS. SPIRONOLACTONE-PLACEBO:
    a) Time-to-event of cardiovascular death over the duration of follow-up.

    b) Time-to-event of the first occurrence of the composite of cardiovascular death, new or worsening heart failure or significant ventricular
    arrhythmia over the duration of follow-up.

    3. COMBINED COLCHICINE AND SPIRONOLACTONE: Time to event of the first occurrence of the composite of cardiovascular death,
    recurrent MI, stroke or new or worsening heart failure over follow up

    4. SYNERGY STENT REGISTRY: Incidence of Definite Stent Thrombosis within 1 year.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time-to-event over duration of follow-up. Minimum follow-up of 1 year to maximum of 5 years (average of 2 years).
    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) Yes
    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 No
    E.8.1.4Double blind Yes
    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
    factorial
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Colombia
    Switzerland
    North Macedonia
    Australia
    Canada
    Serbia
    United Kingdom
    United States
    Czechia
    France
    Hungary
    Poland
    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 years4
    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 years6
    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) Yes
    F.1.2.1Number of subjects for this age range: 2625
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4375
    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 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 state700
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2000
    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)
    Patients that require further treatment following the completion of the trial will be provided with the necessary treatment through the hospitals normal practice. At no point during or after the project will patients be declined treatment.
    Colchicine and spironolactone are both generic drugs that are available by physician prescription outside of this
    research study.
    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 Decision2020-02-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-05
    P. End of Trial
    P.End of Trial StatusOngoing
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