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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2012-001270-28
    Sponsor's Protocol Code Number:Protokół_ASAPOL_wersja4_z_dnia_27_0
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-05-30
    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 number2012-001270-28
    A.3Full title of the trial
    The Risk of Bleeding After Removal of Large Colorectal Polyps in Patients Continuing or Discontinuing on Aspirin: a Multicenter, Double-blind, Placebo-controlled, Randomized Clinical Trial
    Częstość krwawienia po usunięciu polipów jelita grubego u pacjentów kontynuujących lub odstawiających profilaktyczną dawkę kwasu acetylosalicylowego: wieloośrodkowe, podwójnie zaślepione, kontrolowane placebo badanie kliniczne z randomizacją (ASAPOL).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The Risk of Bleeding After Removal of Large Colorectal Polyps in Patients Taking Aspirin
    Ryzyko krwawienia po usunięciu dużych polipów jelita grubego u pacjentów zażywających aspirynę
    A.3.2Name or abbreviated title of the trial where available
    ASAPOL
    ASAPOL
    A.4.1Sponsor's protocol code numberProtokół_ASAPOL_wersja4_z_dnia_27_0
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01549418
    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 SponsorMedical Centre of Postgraduate Education, Poland
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.1.1Trade name Polocard, 75 mg
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    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 namePolocard
    D.3.4Pharmaceutical form Coated 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
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Bleeding after removal large colorectal polyps in patients taking aspirin in profilactic doses or placebo
    Ryzyko krwawienia po usunięciu dużych polipów u pacjentów stosujących aspirynę w dawkach profilaktycznych lub placebo
    E.1.1.1Medical condition in easily understood language
    Bleeding after removal large colorectal polyps in patients taking aspirin in profilactic doses or placebo
    Ryzyko krwawienia po usunięciu dużych polipów u pacjentów stosujących aspirynę w dawkach profilaktycznych lub placebo
    E.1.1.2Therapeutic area Health Care [N] - Health Care Quality, Access, and Evaluation [N05]
    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
    Clinically significant bleeding after polypectomy - any extravasation of blood from the polypectomy site [immediate (30s after polypectomy), early (to 24ha after polypectomy) or delayed (24ha to 30 days after polypectomy)], with clinical and/or endoscopic and/or laboratory (Hb decline by more than 3 g%)symptoms and would require endoscopic intervention and/or surgical and/or blood transfusions;
    Odsetek istotnych klinicznie krwawień w ciągu 30 dni po polipektomii polipów jelita grubego średnicy ≥ 10 mm w grupie pacjentów kontynuujących stosowanie profilaktycznej dawki ASA i grupie pacjentów, u których ASA zastąpiono placebo
    E.2.2Secondary objectives of the trial
    1. Proportion of composite cardiovascular events, ending unplanned hospitalization in both groups aspirin and placebo

    2. Proportion clinicly significant beeding 30 days after polypectomy
    1. Odsetek złożonych zdarzeń sercowo-naczyniowych, zakończonych nieplanowaną hospitalizacją w obu grupach pacjentów w czasie od randomizacji do 30 dnia po polipektomii

    2. Odsetek istotnych klinicznie odroczonych krwawień w ciągu 30 dni po polipektomii w obu grupach pacjentów
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria:
    1. Age 40 years or older
    2. Daily aspirin for primary or secondary prophylaxis
    3. Candidate for endoscopic polypectomy of at least one colorectal polyp 10mm or larger
    4. Signed written informed consent
    5. Written opinion from a cardiologist that the patient can cease taking aspirin for a period of 21 days in the peri-polypectomy period
    1. Wiek ≥ 40 lat
    2. Stosowanie leku z kwasem acetylosalicylowym w prewencji pierwotnej bądź wtórnej zawału serca i udaru mózgu
    3. Zidentyfikowany polip jelita grubego średnicy ≥10mm do planowej polipektomii endoskopowej
    4. Wyrażenie świadomej, pisemnej zgody na udział w badaniu
    5. Uzyskanie pisemnej opinii kardiologa /internisty o dopuszczalności odstawienia kwasu acetylosalicylowego na okres 21 dni w związku z wykonywana polipektomią
    E.4Principal exclusion criteria
    1. Polyposis syndrome
    2. Lifelong anticoagulant therapy with warfarin, acenocumarol, clopidogrel or ticlopidin
    3. Haemorrhagic diathesis
    4. Coagulation disorders INR > 1,5, APTT 2xnorm
    5. Coagulation disorders in family
    6. Heart failure (NYHA III-IV)
    7. Lung disease limiting activities of daily living
    1. Zespół polipowatości
    2. Stałe leczenie przeciwkrzepliwe preparatami acenokumarolu, warfaryny, klopidogrelu lub tiklopidyny
    3. Skaza krwotoczna
    4. Zaburzenia krzepnięcia krwi ( INR> 1,5, APTT 2x norma)
    5. Zaburzenia krzepnięcia w rodzinie
    6. Niewydolność serca (NYHA III-IV)
    7. Choroba płuc ograniczająca codzienną aktywność
    E.5 End points
    E.5.1Primary end point(s)
    Clinically significant bleeding after polypectomy - any extravasation of blood from the polypectomy site [immediate (30s after polypectomy), early (to 24ha after polypectomy) or delayed (24ha to 30 days after polypectomy)], with clinical and/or endoscopic and/or laboratory (Hb decline by more than 3 g%)symptoms and would require endoscopic intervention and/or surgical and/or blood transfusions;
    Odsetek istotnych klinicznie krwawień w ciągu 30 dni po polipektomii polipów jelita grubego średnicy ≥ 10 mm w grupie pacjentów kontynuujących stosowanie profilaktycznej dawki ASA i grupie pacjentów, u których ASA zastąpiono placebo
    E.5.1.1Timepoint(s) of evaluation of this end point
    within 30 days after polypectomy
    w ciągu 30 dni po polipektomii
    E.5.2Secondary end point(s)
    1. Proportion of composite cardiovascular events, ending unplanned hospitalization in both groups aspirin and placebo

    2. Proportion clinicly significant beeding 30 days after polypectomy
    Odsetek złożonych zdarzeń sercowo-naczyniowych, zakończonych nieplanowaną hospitalizacją w obu grupach pacjentów w czasie od randomizacji do 30 dnia po polipektomii

    2. Odsetek istotnych klinicznie odroczonych krwawień w ciągu 30 dni po polipektomii w obu grupach pacjentów
    E.5.2.1Timepoint(s) of evaluation of this end point
    within 30 days after polypectomy
    w czasie 30 dni po polipektomii
    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 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    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 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 concerned5
    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
    The last visit of the last patient
    Ostatnia wizyta ostatniego pacjenta
    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: 760
    F.1.3Elderly (>=65 years) Yes
    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 state760
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 760
    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)
    Surveillance after polypectomy in accordance with guidelines of the European Society of Gastroenterology
    Nadzór po polipektomii zgodnie z wytycznymi Europejskiego Towarzystwa Gastroenterologicznego
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
    G.4.3.4Network Country Poland
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-09-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-28
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-03-28
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