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    Summary
    EudraCT Number:2020-000721-11
    Sponsor's Protocol Code Number:CHPAU2019/03
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2020-06-19
    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 ConcernedFrance - ANSM
    A.2EudraCT number2020-000721-11
    A.3Full title of the trial
    Management of Anticoagulant Therapy monitored by an implantable device with telecardiology in patients with Acute Coronary Syndrome associated with de novo atrial Fibrillation Arrhythmia (SCA-FA): A prospective multicenter study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Management of Anticoagulant Therapy monitored by an implantable device with telecardiology in patients with Acute Coronary Syndrome associated with de novo atrial Fibrillation Arrhythmia
    A.3.2Name or abbreviated title of the trial where available
    SCAFA
    A.4.1Sponsor's protocol code numberCHPAU2019/03
    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 SponsorCentre hospitalier de PAU
    B.1.3.4CountryFrance
    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 supportUnité de Recherche Clinique du CH de PAU
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUnité de Recherche Clinique
    B.5.2Functional name of contact pointAlice Séris
    B.5.3 Address:
    B.5.3.1Street Address4 boulevard Hauterive
    B.5.3.2Town/ cityPAU
    B.5.3.3Post code64046
    B.5.3.4CountryFrance
    B.5.4Telephone number33559726997
    B.5.5Fax number33559727769
    B.5.6E-mailalice.seris@ch-pau.fr
    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 nameanticoagulant
    D.3.2Product code not applicable
    D.3.4Pharmaceutical form
    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 and atrial fibrillation
    E.1.1.1Medical condition in easily understood language
    acute coronary syndrome and atrial fibrillation
    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 10051592
    E.1.2Term Acute coronary syndrome
    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 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
    To show that the introduction of an anticoagulant treatment in patients with ACS and de novo AF based on the data furnished by an implantable holter with remote monitoring is safer in terms of occurrence of hemorrhagic events than the systematic introduction of an anticoagulant treatment associated to DAPT based on the CHA2DS2-VASc score.
    E.2.2Secondary objectives of the trial
    To show that the absence of anticoagulant therapy, except in case of AF recurrence detected in the data furnished by an implantable holter with remote monitoring, in patients with ACS and de novo AF does not lead to additional secondary complications during follow-up. These complications are measured with various indicators (MACCE composite endpoint, ischemic risk composite endpoint, and detailed ischemic risk measurement endpoint by type), and compared with those of patients receiving systematic anticoagulant therapy based on the CHA2DS2-VASc score.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients, aged ≥18.
    - Hospitalization for acute coronary syndrome with or without ST segment elevation.
    - Atrial fibrillation present at the time of patient arrival at the hospital or occurring at any time during hospitalization. Patient without any prior known history of arrhythmia.
    - chads2vas SCORE ≥ 1 for men and ≥ 2 for women.
    - Ablation of atrial fibrillation before enrollment in the study. The atrial fibrillation ablation can be spontaneous or obtained by treatment.
    E.4Principal exclusion criteria
    Pathologic criteria :
    - Atrial fibrillation diagnosed before hospitalization for acute coronary syndrome, whether treated or not.
    - Atrial fibrillation still present at inclusion time.
    - Transient atrial fibrillation due to a reversible disorder (thyrotoxycosis, pulmonary embolism, recent surgery).
    - Acute coronary syndrome that has not been revascularized.
    - Acute coronary syndrome surgically treated (bypass).
    - Patient already on anticoagulant therapy.
    - Scheduled aortocoronary bypass.
    - Creatinine clearance < 30 ml per minute.

    Bleeding risks :
    - Contraindications to anticoagulant therapy.
    - Active internal hemorrhage, clinically significant bleeding, bleeding non accessible to compression or bleeding diathesis within 30 days prior to selection visit.
    - Platelet count < 90000/µL at the selection visit.
    - Bleeding event in the twelve months prior to inclusion.
    - Bleeding events detected either clinically or biologically (hemoglobinemia < 10g/dl).
    - Elective surgery.

    Comorbidities :
    - Cardiogenic shock.
    - Hyperthyroidism.
    - Prior history of significant liver disease (acute hepatitis, active chronic hepatitis, cirrhosis) or liver function disorder detected at selection visit.
    - Significant mitral valvular heart disease.
    E.5 End points
    E.5.1Primary end point(s)
    Occurred during the 2 years following a hemorrhagic event defined by a score ≥2 according to the BARC scale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 years
    E.5.2Secondary end point(s)
    Occurrence of an event defined by the MACCE indicator
    - Occurrence of an ischemic event defined by the following composite indicator: death from cardiovascular cause, stroke or systemic embolism, non-fatal infarction and need for revascularization.
    - For each constituent element of the composite ischemic indicator, occurrence of the ischemic event taken individually: death from cardiovascular cause, stroke or systemic embolism, non-fatal infarction and need for revascularization.
    - For the haemorrhagic risk measured with the BARC scale, the main endpoint (BARC score ≥2) will be supplemented by the other results obtained with this scale.
    E.5.2.1Timepoint(s) of evaluation of this end point
    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) 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 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
    standard management
    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 concerned10
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months54
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months54
    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: 500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 500
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women Yes
    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 state500
    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
    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 Decision2020-08-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-24
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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