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    Summary
    EudraCT Number:2015-000233-73
    Sponsor's Protocol Code Number:HCQvJan11
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-11-23
    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 ConcernedFinland - Fimea
    A.2EudraCT number2015-000233-73
    A.3Full title of the trial
    HYDROXYCHLOROQUINE IN ACUTE CORONARY SYNDROME: PREVENTION OF RECURRENT CARDIOVASCULAR EVENTS
    Hydroksiklorokiini akuutissa koronaari syndroomassa: Tulevien kardiovaskulaaritapahtumien ehkäisy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Hydroxychloroquine in the prevention of cardiovascular events in high risk patients
    Hydroksiklorokiini sydän- ja verisuonisairauksien estossa korkean riskin potilailla
    A.4.1Sponsor's protocol code numberHCQvJan11
    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 SponsorHelsinki University Central Hospital
    B.1.3.4CountryFinland
    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 supportHelsinki University Central Hospital (ERVA financing)
    B.4.2CountryFinland
    B.4.1Name of organisation providing supportFinnish foundation for cardiovascular research
    B.4.2CountryFinland
    B.4.1Name of organisation providing supportOrion ltd
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHelsinki University Central Hospital
    B.5.2Functional name of contact pointJuha Sinisalo
    B.5.3 Address:
    B.5.3.1Street AddressHaartmaninkatu 4
    B.5.3.2Town/ cityHelsinki
    B.5.3.3Post code00029HUS
    B.5.3.4CountryFinland
    B.5.4Telephone number358094711
    B.5.6E-mailjuha.sinisalo@hus.fi
    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 Oxiklorin / Plaquenil
    D.2.1.1.2Name of the Marketing Authorisation holderAventis Pharma Limited
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHYDROXYCHLOROQUINE
    D.3.9.1CAS number 118-42-3
    D.3.9.4EV Substance CodeSUB08077MIG
    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 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
    Cardiovascular disease
    Sydän- ja verisuonisairaudet
    E.1.1.1Medical condition in easily understood language
    Heart diseases
    Sydän- ja verisuonisairaudet
    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 study the effect of hydroxychloroquine on cardiovascular risk factors in high risk cardiovascular patients
    Tutkia hydroksiklorokiinin vaikutusta sydän- ja verisuonitauitien riskitekijöihin, sekä selvittää estääkö hydroksiklorokiini tulevia sydäntapahtumia korkean riskin potilailla
    E.2.2Secondary objectives of the trial
    The effect of hydroxychloroquine in the prevention of future cardiovascular events in high risk cardiovascular patients
    Tutkia estääkö hydroksiklorokiin sydän- ja verisuonitauti tapahtumia korkean riskin potilailla
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1 Anginal Presentation
    Patients of either gender who enter the hospital with prolonged or repetitive chest pain together with clearly documented ST- T wave changes indicating either unstable angina, NSTEMI or STEMI. All patients must have anginal symptoms suggestive of cardiac ischemia with one of the clinical presentations which are given in research plan
    2 ECG Criteria (given in research plan; patient must have at least one)
    3 Biochemical markers of myocardial damage


    1 Angiina
    Potilaalla joka tulee päivystykseen pitkittynyt rintakipu tai toistuva rintakipu ja EKG muutoksia sopien joko epästabiiliin angiinaan. NSTEMI tai STEMI.ö Kaikilla täytyy olla angiina oireita sopien iskemiaan (oireet lueteltu tutkimussuunnitelmassa).
    2 EKG kriteerit täyttyvät (annettu tutkimussuunnitelmassa
    3. Biokemialliset markkerit viittaavat myokardi vaurioon
    E.4Principal exclusion criteria
    1) Hypersensitivity to HCQ
    2) Porfyria
    3) Rheumatoid arthritis or other rheumatic disease
    4) Retinopathy of any cause, or other eye diseases that could worsen by the use of HCQ
    5) Significant neuropathy of any cause
    6) Cardiomyopathy (dignosed before the onset of index hospitalization .i.e heart failure due to index myocardial infarction is not exclusion criteria)
    7) Muscle disease (that could worsen by the use of HCQ)
    8) Psoriasis
    9) Any other disease or reason why investigator deems the patient not suitable for the study
    1 Yliherkkyys hydroksiklorokiinille
    2. porfyria
    3. Nivelreuma tai muu reumaattinen sairaus
    4. Retinopaatia tai muu merkittävä silmäsairaus mikä voi pahentua hydroksilorokiinin vaikutukssta
    5. Merkittävä neuropatia
    6. Kardiomyopatia
    7. Lihassairaus
    8. psoriaasi
    9.Muu syy joka tutkijan mielestä estää osallistumisen tutkimukseen
    E.5 End points
    E.5.1Primary end point(s)
    Does the HCQ therapy diminish major coronary complication (=death, acute myocardial infarctions, recurrent UAP [requiring hospitalization], urgent PCI, -CABG) event rate during six months HCQ course in ACS patients.
    Estääkö hydroksiklorokiini hoito merkittäviä koronaari tapahtumia 6 kuukauden seurannan aikana (kuolema, sydäninfarkti toistuva UAP, kiireinen ICP, CABG)
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    6 kuukautta
    E.5.2Secondary end point(s)
    1) The effect of HCQ on the blood lipi levels (LDL, HDL, TG)
    2) The effect of 6 months treatment with HCQ on levels of inflammatory parameters i.e high sensitive CRP and erythrocyte sedimentation rate,
    3) The effect of 6 months treatment with HCQ on incidence of type II diabetes and the level of HBA1c
    4) The effect of HCQ treatment on other inflammation related parameters such as TNF-alfa, IL-6, IL-1beta, IL-18. In addition mRNA samples from serum mononuclear cells will be collected to assess the expression of key proinflammatory cytokines and genes related to inflammasome activation which has been implicated in the pathogenesis of atherosclerosis. These include the expression of NLRP3, ASC and caspase-1.
    5) Composite endpoint of death, acute myocardial infarctions, reUAP [requiring hospitalization], urgenPCI, -CABG and stroke within nine months.
    1. Kuuden kuukauden hydroksiklorokiinihoiodon vaikutus veren rasva-arvoihin (LDL, HDL TG)
    2. Kuuden kuukauden hydroksiklorokiinihoiodon vaikutus tulehdusparametreihin (hcCRP,la)
    3. Kuuden kuukauden hydroksiklorokiinihoiodon vaikutus tyyppi II diabeteksen ilmaantuvuuten ja HBA!c tasoihin
    4. Kuuden kuukauden hydroksiklorokiinihoiodon vaikutus proinflammatoirisiin sytokiineihin, inflammasomin aktivaatioon jne.
    5. Komposiitti end point; kuolema akuutti infarkti reUAP (sairaalahoitoa vaativa), kiireinen PCI, CABG, aivoinfarkti seuraavan 9 kuukauden aikana
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months and 9 months
    6 ja 9 kuukautta
    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 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 Yes
    E.6.11Pharmacogenomic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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 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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    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.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state200
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 200
    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 will be taken care by their own doctors by standard care. Ending the use of the study drug should not have any effect on the disease course
    potilaita hoitaa jatkossa heidän oma lääkärinsä normaalin hoidon mukaisesti. tutkimuksen loppuminen ei vaikuta hoitoon tai taudin kulkuun
    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 Decision2016-01-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-16
    P. End of Trial
    P.End of Trial StatusOngoing
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