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    Summary
    EudraCT Number:2021-006127-17
    Sponsor's Protocol Code Number:CKD/1458/21
    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:2022-03-14
    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 number2021-006127-17
    A.3Full title of the trial
    Optimal Antiplatelet Treatment to Achieve Stroke Avoidance and Fall in
    Bleeding Events following Left Atrial Appendage Closure – Chronic Kidney
    Disease (SAFE LAAC CKD). Comparative Health Effectiveness Ancillary
    Study – PILOT
    Optymalna terapia przeciwpłytkowa po przeznaczyniowym zamknięciu
    uszka lewego przedsionka – przewlekła choroba nerek (SAFE LAAC CKD).
    Towarzyszące badanie porównawcze efektywności zdrowotnej –
    pilotażowe
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Optimal antiplatelet treatment after left atrial appendage closure in chronic
    kidney disease patients
    Optymalna terapia przeciwpłytkowa po zabiegu zamknięcia uszka lewego
    przedsionka u pacjentów z przewlekłą chorobą nerek
    A.3.2Name or abbreviated title of the trial where available
    SAFE LAAC CKD
    SAFE LAAC CKD
    A.4.1Sponsor's protocol code numberCKD/1458/21
    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 SponsorNarodowy Instytut Kardiologii Stefana kardynała Wyszyńskiego- Państwowy Instytut Badawczy
    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 supportMedical Research Agency
    B.4.2CountryPoland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNational Institute of Cardiology
    B.5.2Functional name of contact pointClinical Research Support Center
    B.5.3 Address:
    B.5.3.1Street AddressAlpejska 42
    B.5.3.2Town/ cityWarsaw
    B.5.3.3Post code04-628
    B.5.3.4CountryPoland
    B.5.4Telephone number0048223434268
    B.5.5Fax number0048223434506
    B.5.6E-mailbadaniakliniczne@ikard.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.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 INNClopidogrel
    D.3.9.1CAS number 113665-84-2
    D.3.9.3Other descriptive nameclopidogrel
    D.3.9.4EV Substance CodeSUB13395MIG
    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.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 INNACETYLSALICYLIC ACID
    D.3.9.1CAS number 50-78-2
    D.3.9.4EV Substance CodeSUB12730MIG
    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
    Atrial fibrillation
    Migotanie przedsionków
    E.1.1.1Medical condition in easily understood language
    Atrial fibrillation
    Migotanie przedsionków
    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 PT
    E.1.2Classification code 10003658
    E.1.2Term Atrial fibrillation
    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
    1. To compare safety and efficacy of early DAPT discontinuation at 30
    days postprocedure and continuation of SAPT up until 6-month vs 6
    months of postprocedural DAPT in patients with end-stage renal disease on chronic dialysis (randomized comparison)
    2. To compare safety and efficacy of chronic SAPT beyond 6 months
    postprocedure vs discontinuation of all antiplatelet treatment 6 months
    after LAAC in patients with end-stage renal disease on chronic dialysis (nonrandomized comparison).
    1. Porównanie bezpieczeństwa i skuteczności strategii odstawienia podwójnego leczenia przeciwpłytkowego i kontynuacji leczenia pojedynczym lekiem przeciwpłytkowym po 30 dniach od przezskórnego zamknięcia uszka lewego przedsionka ze strategią kontynuowania podwójnego leczenia przeciwpłytkowego do 6 miesięcy po zabiegu w populacji pacjentów ze schyłkową niewydolnością nerek będących w programie przewlekłych dializ (porównanie randomizowane).

    2. Porównanie bezpieczeństwa i skuteczności przewlekłego leczenia pojedynczym lekiem przeciwpłytkowym vs. odstawienie leczenia przeciwpłytkowego po 6 miesiącach od zabiegu zamknięcia uszka lewego przedsionka w obserwacji 12 miesięcznej w populacji pacjentów ze schyłkową niewydolnością nerek będących w programie przewlekłych dializ (porównanie nierandomizowane).
    E.2.2Secondary objectives of the trial
    Assessment of safety and efficacy of transcatheter left atrial appendage occlusion in patients with end-stage renal disease on chronic dialysis (retrospective registry)
    Ocena skuteczności i bezpieczeństwa zabiegu zamknięcia uszka lewego przedsionka w populacji pacjentów ze schyłkową niewydolnością nerek będących w programie przewlekłych dializ (rejestr retrospektywny).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Successful percutaneous left atrial appendage occlusion with
    Amplatzer or WATCHMAN devices within 37 days prior to randomization
    2. End-stage renal disease treated with chronic hemodialysis or chronic peritoneal dialysis
    3. Age >= 18 yrs
    4. Participant is willing to comply with all aspects of the protocol
    including the assigned treatment strategy and follow-up visits
    5. The participant is willing to give written informed consent
    1. Skuteczny zabieg LAAC z wykorzystaniem urządzenia Amplatzer lub
    WATCHMAN w ciągu maksymalnie 37 dni poprzedzających randomizację
    2. Schyłkowa niewydolność nerek w programie przewlekłych hemodializ lub dializy otrzewnowej
    3. Wiek w dniu podpisania formularza świadomej zgody ≥ 18 lat
    4. Uczestnik wyraża chęć przestrzegania protokołu badania, w
    szczególności określonych protokołem zasad leczenia
    przeciwpłytkowego oraz wizyt kontrolnych
    5. Uczestnik jest skłonny wyrazić świadomą, pisemną zgodę na udział w badaniu.
    E.4Principal exclusion criteria
    1. Any indication to chronic antiplatelet therapy other than atrial
    fibrillation or left atrial appendage occlusion.
    2. Indications to chronic anticoagulation
    3. Known allergy to clopidogrel of acetylsalicylic acid
    4. Diagnosis of coagulation disorders
    5. Peridevice leaks greater than 5mm
    6. Thrombus in the left atrium on the qualifying imaging of the left
    atrium
    7. Life expectancy less than the duration of the trial due to
    noncardiovascular comorbidity
    8. Enrollment into a competing trial using a non-approved devices or
    drugs - currently and up to 3 months prior to enrolment
    9. Women who are pregnant or breastfeeding and those women of
    childbearing potential who
    do not agree to use at least two contraceptive measures (oral
    contraception, mechanical contraception, approved contraceptive
    implants, intrauterine device, tubal ligation). The criterion does not
    apply to women who have been postmenopausal for at least 2 years
    prior to study enrollment (defined as at least one year without menstrual
    periods) or underwent surgical sterilization procedure. All eligible
    women who are younger than 55 years must have negative pregnancy
    test within 24 hours prior to randomization.
    1. Obecność wskazań do podwójnej terapii przeciwpłytkowej innych niż LAAC i/lub przewidywane pojawienie się tych wskazań w czasie trwania badania (np. planowana rewaskularyzacja wieńcowa),
    2. Obecność wskazań do leczenia przeciwzakrzepowego i/lub przewidywane pojawienie się tych wskazań w czasie trwania badania (np. zatorowość płucna). Nie dotyczy antykoagulacji stosowanej podczas dializoterapii,
    3. Znane uczulenie na klopidogrel i/lub kwas acetylosalicylowy uniemożliwiające przyjmowanie tych leków zgodnie z protokołem badania,
    4. Jakiekolwiek rozpoznane, nabyte lub wrodzone zaburzenia układu krzepnięcia (np. trombofilie, skazy krwotoczne),
    5. Przeciek wokół urządzenia >5mm stwierdzony podczas ostatniego obrazowania przed włączeniem do badania,
    6. Skrzeplina w lewym przedsionku stwierdzona w obrazowaniu kwalifikującym do badania.
    7. Oczekiwana długość życia uczestnika mniejsza niż 18 miesięcy,
    8. Uczestnictwo w innym badaniu klinicznym z wykorzystaniem doświadczalnych urządzeń i/lub leków obecnie i do 3 miesięcy przed planowanym włączeniem do badania,
    9. Kobiety w ciąży lub karmiące piersią oraz kobiety o potencjale rozrodczym, które nie zgadzają się na stosowanie co najmniej dwóch metod antykoncepcji (doustne środki antykoncepcyjne, metody mechaniczne, zatwierdzony implant antykoncepcyjny, długodziałające zastrzyki antykoncepcyjne, wkładka domaciczna lub podwiązanie jajowodów). Warunek ten nie dotyczy kobiet, które przeszły menopauzę (definiowaną jako rok lub dłużej od ostatniej miesiączki) co najmniej 2 lata wcześniej ORAZ jeśli są w wieku poniżej 55 lat, muszą mieć ujemny wynik testu ciążowego w ciągu 24 godzin poprzedzających randomizację, a także kobiet, które przeszły zabieg chirurgicznej sterylizacji.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint: comprising major adverse cardiac and
    cerebrovascular events defined as: 1. efficacy: MACCE - stroke, TIA,
    peripheral embolism, nonfatal myocardial infarction, cardiovascular and
    overall mortality; device related thrombosis; and 2. safety: moderate and
    severe bleedings (type 2-5 BARC).
    Główny punkt końcowy: złożony z niepożądanych zdarzeń sercowo- i
    mózgowo-naczyniowych określających 1. skuteczność: (MACCE - udar,
    TIA, zatorowość obwodowa, zawał serca niezakończony zgonem,
    śmiertelność sercowo-naczyniowa i całkowita; skrzeplina związana z
    okluderem w uszku lewego przedsionka) i 2. bezpieczeństwo:
    umiarkowane i poważne krwawienia (typ 2-5 w skali BARC)
    E.5.1.1Timepoint(s) of evaluation of this end point
    English 5 months
    17 months
    landmark analysis at 17months of endpoints gathered between the 5 and
    17months
    5 miesięcy
    17 miesięcy
    "landmark analysis" po 17 miesiącach dla punktów końcowych
    zebranych pomiędzy 5 i 17 miesiącem
    E.5.2Secondary end point(s)
    individual components of the composite primary end point and:
    1. any bleeding
    2. new intermediate and large ischemic lesions (≥4mm in size) in
    central nervous system as assessed by brain MRI
    3. new cognitive disorders as assessed by Addenbrooke's Cognitive
    Examination (ACE-III)
    4. thrombosis of the dialysis access
    5. efficacy and safety of LAAC in the periprocedural and 1 month follow-up
    poszczególne składowe głównego punktu końcowego określające
    skuteczność, bezpieczeństwo oraz:
    1. jakiekolwiek krwawienie
    2. nowe średnie lub duże ogniska niedokrwienne (o wymiarze ≥4mm)
    w ośrodkowym układzie nerwowym ocenianych w badaniu rezonansu
    magnetycznego
    3. nowe zaburzenia kognitywne oceniane wg Skali Funkcjonowania Poznawczego Addenbrooka's (ang. Addenbrooke's Cognitive
    Examination, ACE-III)
    4. Zakrzep dostępu dializacyjnego
    5. Skuteczność i bezpieczeństwo zabiegu LAAC w okresie okołozabiegowym i 1 miesięcznym na podstawie danych rejestrowych
    E.5.2.1Timepoint(s) of evaluation of this end point
    5 months
    17 months
    landmark analysis at 17months of endpoints gathered between the 5 and
    17months
    5 miesięcy
    17 miesięcy
    "landmark analysis" po 17 miesiącach dla punktów końcowych
    zebranych pomiędzy 5 i 17 miesiącem
    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) 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 Yes
    E.8.1.7.1Other trial design description
    bez leczenia
    no treatment
    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
    bez leczenia
    no treatment
    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 concerned7
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state80
    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
    Bez
    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 Decision2022-04-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-11
    P. End of Trial
    P.End of Trial StatusOngoing
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