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    Summary
    EudraCT Number:2020-004962-21
    Sponsor's Protocol Code Number:MC-ACS01-2020
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-12-14
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2020-004962-21
    A.3Full title of the trial
    "MetCool ACS”- Metformin “Cooling” Effect on metformin-naive Patients Treated with PCI because of Acute Coronary Syndrome
    “MetCool ACS”- stabilizujacy wpływ metforminy u pacjentów do tej pory jej nieprzyjmujących a leczonych przezskórną angioplastyką wieńcową (PCI) z powodu ostrego zespołu wieńcowego
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    "MetCool ACS”- Metformin “Cooling” Effect on metformin-naive Patients Treated with PCI because of Acute Coronary Syndrome
    “MetCool ACS”- stabilizujacy wpływ metforminy u pacjentów do tej pory jej nie przyjmujących a leczonych przezskórną angioplastyką wieńcową (PCI) z powodu ostrego zespołu wieńcowego
    A.3.2Name or abbreviated title of the trial where available
    MetCool ACS
    MetCool ACS
    A.4.1Sponsor's protocol code numberMC-ACS01-2020
    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 SponsorWojskowy Instytut Medyczny
    B.1.3.4CountryPoland
    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 supportWojskowy Instytut Medyczny
    B.4.2CountryPoland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationWojskowy Instytut Medyczny
    B.5.2Functional name of contact pointWojskowy Instytut Medyczny
    B.5.3 Address:
    B.5.3.1Street Addressul. Szaserów 128
    B.5.3.2Town/ cityWarszawa
    B.5.3.3Post code04-141
    B.5.3.4CountryPoland
    B.5.4Telephone number4822606619195
    B.5.6E-mailpkwiatkowski@wim.mil.pl
    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 GLUCOPHAGE 500 mg
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sante s.a.s., 37 rue Saint – Romain 69008 Lyon Francja
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameMetformin
    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.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 GLUCOPHAGE 850 mg
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sante s.a.s., 37 rue Saint – Romain 69008 Lyon Francja
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameMetformin
    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
    Acute coronary syndrome
    Ostry zespół wieńcowy
    E.1.1.1Medical condition in easily understood language
    Acute coronary syndrome
    Ostry zespół wieńcowy
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10007541
    E.1.2Term Cardiac disorders
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10011082
    E.1.2Term Coronary artery disorders
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10011085
    E.1.2Term Ischaemic coronary artery disorders
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10051592
    E.1.2Term Acute coronary syndrome
    E.1.2System Organ Class 10007541 - Cardiac disorders
    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 of the study is to evaluate the effect of metformin in reducing the rate of unplanned coronary revascularization in nondiabetic patients treated with percutaneous coronary angioplasty (PCI) for acute coronary syndrome.
    Pierwszorzędowym celem badania jest ocena wpływu metforminy na redukcję odsetka nieplanowanych zabiegów rewaskularyzacji wieńcowej u pacjentów bez cukrzycy leczonych przezskórną angioplastyką wieńcową (PCI) z powodu ostrego zespołu wieńcowego.
    E.2.2Secondary objectives of the trial
    1. To evaluate the effects of metformin on other major cardiovascular events in nondiabetic patients treated with percutaneous coronary angioplasty (PCI) for acute coronary syndrome.
    2. To assess the safety of metformin use in nondiabetic patients treated with percutaneous coronary angioplasty (PCI) for acute coronary syndrome.
    1. Ocena wpływu metforminy na występowanie innych poważnych zdarzeń sercowo-naczyniowych u pacjentów bez cukrzycy leczonych przezskórną angioplastyką wieńcową (PCI) z powodu ostrego zespołu wieńcowego
    2. Ocena bezpieczeństwa stosowania metforminy u pacjentów bez cukrzycy leczonych przezskórną angioplastyką wieńcową (PCI) z powodu ostrego zespołu wieńcowego
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    IC-1 Age >18 years
    IC-2 First episode of the ACS in accordance with ESC (European Society of Cardiology) treating with percutaneous coronary intervention with drug-eluting stent implantation
    IC-3 Profession, place of residence (but close enough that it will not cause difficulty in monitoring during research)
    IC-4 Uncomplicated course of the disease (ACS) as assessed by the treating physician
    IC-5 Patient negative history of diabetes
    IC-6 No hypoglycemic drugs before the admission or in the last 6 months
    IC-7 HbA1c< 6,5% (assessment during hospitalization)
    IC-8 Written consent to participate in the study
    IC-1 Wiek > 18 roku życia
    IC-2 OZW, zgodnie z aktualną definicją Europejskiego Towarzystwa Kardiologicznego, leczony zabiegiem przezskórnej interwencji wieńcowej z implantacją stentu uwalniającego lek
    IC-3 Zawód i miejsce zamieszkania niepowodujące trudności w uczestniczeniu w kontrolnych wizytach
    IC-4 Niepowikłany przebieg OZW w ocenie lekarza prowadzącego
    IC-5 Negatywny wywiad w kierunku cukrzycy u pacjenta
    IC-6 Niestosowanie żadnych leków hipoglikemizujących przed hospitalizacją bezpośrednio lub w ciągu ostatnich 6 miesięcy
    IC-7 HbA1c < 6,5% (ocena w trakcie hospitalizacji)
    IC-8 Pisemna zgoda na udział w badaniu
    E.4Principal exclusion criteria
    EC-1. Significant valvular disease confirmed in ECHO
    EC-2. History of previous CABG
    EC-3. NYHA IV during hospitalization
    EC-4. Chronic kidney disease with GFR< 60 ml/min/1,73 m2 modo MDRD
    EC-5. ALT three times over UNL (upper normal limit) according to the laboratory criteria
    EC-6. Serious co-morbidity and estimated survival time of less than 2.5 years- as assessed by the treating physician
    EC-7. Known gastro-intestinal disease which could be potentially responsible for metformin intolerance (eg inflammatory bowel disease, GERD- gastro-esophageal reflux
    disease)- this criterion only for patients from “treatment group”
    EC-8. Known potential difficulties in collaboration with patients (dementia, mental disorders, distance from patients residence if considered as potentially problematic, alcoholism)
    EC-9. Hypersensivity to metformin
    EC-10. Pregnancy and breast - breeding
    EC-11. Patient participation in another study
    EC-1. Istotna wada zastawkowa potwierdzona w badaniu ECHO
    EC-2. Przebyte CABG
    EC-3. NYHA IV w trakcie hospitalizacji
    EC-4. Przewlekła choroba nerek z GFR < 60 ml/min/1,73m2 według MDRD
    EC-5. ALT trzykrotnie powyżej normy zgodnie z kryteriami laboratoryjnymi
    EC-6. Poważne choroby współistniejące i szacowany czas przeżycia krótszy niż 2,5 roku – według oceny lekarza prowadzącego
    EC-7. Rozpoznana choroba przewodu pokarmowego, która może być potencjalnie odpowiedzialna za nietolerancję metforminy (np. nieswoiste zapalenie jelit, choroba refluksowa przełyku)
    EC-8. Znane potencjalne trudności we współpracy z pacjentami (demencja, zaburzenia psychiczne, odległość od miejsca zamieszkania, jeśli uznana za potencjalnie problematyczną, alkoholizm)
    EC-9. Nadwrażliwość na metforminę
    EC-10. Ciąża i karmienie piersią
    EC-11. Udział pacjenta w innym badaniu klinicznym
    E.5 End points
    E.5.1Primary end point(s)
    1. The need to perform unplanned PCI or CABG after successful last stage of full revascularization because of ACS
    1. Konieczność wykonania nieplanowanej PCI lub CABG po udanym ostatnim etapie rewaskularyzacji z powodu OZW w 30-miesięcznym okresie obserwacji
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. The need to perform unplanned PCI or CABG after successful last stage of full revascularization because of ACS
    1. Konieczność wykonania nieplanowanej PCI lub CABG po udanym ostatnim etapie rewaskularyzacji z powodu OZW w 30-miesięcznym okresie obserwacji
    E.5.2Secondary end point(s)
    1. Cardiac death after successful final stage of revascularization due to ACS in the 30-month follow-up period
    2. Death from any cause after successful final stage of revascularization due to ACS in the 30-month follow-up period
    3. Non-fatal myocardial infarction after successful final stage of revascularization due to ACS in the 30-month follow-up period
    4. Non-fatal stroke after successful final stage of revascularization due to ACS in the 30-month follow-up period
    1. Zgon z przyczyn sercowych po udanym ostatnim etapie rewaskularyzacji z powodu OZW w 30-miesięcznym okresie obserwacji
    2. Zgon z jakiejkolwiek przyczyny po udanym ostatnim etapie rewaskularyzacji z powodu OZW w 30-miesięcznym okresie obserwacji
    3. Zawał mięśnia serca niezakończony zgonem po udanym ostatnim etapie rewaskularyzacji z powodu OZW w 30-miesięcznym okresie obserwacji
    4. Udar mózgu niezakończony zgonem po udanym ostatnim etapie rewaskularyzacji z powodu OZW w 30-miesięcznym okresie obserwacji
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. The percentage of cardiac deaths after successful final stage of revascularization due to ACS in the 30-month follow-up period
    2. All-cause death rate after successful final stage of revascularization due to ACS in the 30-month follow-up period
    3. The percentage of non-fatal myocardial infarctions after successful final stage of revascularization due to ACS in the 30-month follow-up period
    4. Percentage of non-fatal strokes after successful final stage of revascularization due to ACS in the 30-month follow-up period
    5. To assess the safety profile of metformin in this patient population based on the rate of adverse events recorded
    1. Odsetek zgonów sercowych po udanym ostatnim etapie rewaskularyzacji z powodu OZW w 30-miesięcznym okresie obserwacji
    2. Odsetek zgonów z jakiejkolwiek przyczyny po udanym ostatnim etapie rewaskularyzacji z powodu OZW w 30-miesięcznym okresie obserwacji
    3. Odsetek zawałów serca niezakończonych zgonem po udanym ostatnim etapie rewaskularyzacji z powodu OZW w 30-miesięcznym okresie obserwacji
    4. Odsetek udarów niezakończonych zgonem po udanym ostatnim etapie rewaskularyzacji z powodu OZW w 30-miesięcznym okresie obserwacji
    5. Ocena profilu bezpieczeństwa metforminy w tej populacji pacjentów na podstawie odsetka zarejestrowanych zdarzeń niepożądanych
    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 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.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) No
    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
    Zwyczajowe leczenie lub opieka w grupie kontrolnej (standard of care).
    Usual treatment or standard of care.
    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 concerned24
    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, but no later than 30.04.2026 r.
    LVLS, ale nie później niż do 30.04.2026 r.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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: 670
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 330
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2020-12-14. Yes
    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 state1000
    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)
    None
    None
    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 Decision2021-07-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-18
    P. End of Trial
    P.End of Trial StatusOngoing
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