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    Summary
    EudraCT Number:2020-004784-53
    Sponsor's Protocol Code Number:APHP200002
    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:2022-04-25
    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 number2020-004784-53
    A.3Full title of the trial
    Rivaroxaban versus standard of care for patients with excessive atrial ectopy or short atrial runs and high embolism risk
    SHORT RUN AF
    Rivaroxaban versus traitement standard pour les patients présentant une extrasystolie atriale excessive ou des salves atriales non soutenues avec un risque thromboembolique élevé
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Rivaroxaban versus standard of care for patients with excessive atrial ectopy or short atrial runs and high embolism risk SHORT RUN AF
    A.3.2Name or abbreviated title of the trial where available
    SHORT RUN AF
    A.4.1Sponsor's protocol code numberAPHP200002
    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 SponsorAssistance Publique - Hôpitaux de Paris
    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 supporthealth Ministry
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAssistance Publique - Hôpitaux de Paris
    B.5.2Functional name of contact pointproject Manager
    B.5.3 Address:
    B.5.3.1Street Address1, avenue Claude Vellefaux
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number+330144841749
    B.5.6E-mailwafa.fethallah@aphp.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 Yes
    D.2.1.1.1Trade name Xarelto 10 mg comprimé pelliculé
    D.2.1.1.2Name of the Marketing Authorisation holderBayer AG
    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 nameXARELTO 10 mg
    D.3.4Pharmaceutical form Coated 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 INNRivaroxaban
    D.3.9.1CAS number 366789-02-8
    D.3.9.4EV Substance CodeSUB29263
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Xarelto 15 mg comprimé pelliculé
    D.2.1.1.2Name of the Marketing Authorisation holderBayer AG
    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 nameXARELTO 15 mg
    D.3.4Pharmaceutical form Coated 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 INNRivaroxaban
    D.3.9.1CAS number 366789-02-8
    D.3.9.4EV Substance CodeSUB29263
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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
    excessive atrial ectopy or short atrial runs and high embolism risk
    E.1.1.1Medical condition in easily understood language
    excessive atrial ectopy or short atrial runs and high embolism risk
    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 LLT
    E.1.2Classification code 10042601
    E.1.2Term Supraventricular ectopics
    E.1.2System Organ Class 100000004849
    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 Short Run AF study is to evaluate the efficacy and safety of long term anticoagulation with rivaroxaban against standard of care (SOC) in patients with ESVEA and CHA2DS2VASC score ≥3 on the incidence of ischemic stroke and peripheral embolism after 2 years follow-up and the occurrence of major bleeding events.
    E.2.2Secondary objectives of the trial
    Secondary objectives will include:
    - Efficacy-related objectives:
    o To compare randomized groups on net clinical benefit, major cardiovascular events, overall survival, cognitive decline.
    o To compare randomized groups on individual components of composite primary and secondary efficacy endpoints
    - Exploratory objectives:
    o To describe and compare between randomized groups the incidence of documented atrial fibrillation diagnosed from patient symptoms or systematic 24 hours ECG Holter performed at 1 year and 2-year follow-up.
    o To evaluate through cerebral MRI the incidence of asymptomatic cerebral damage including silent cerebral ischemia and microbleeds at 2-year follow-up.
    - Safety-related objectives:
    o To assess the occurrence of life-threatening or fatal bleeding, clinically relevant non-major bleeding intracranial hemorrhage and minor bleeding
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    o Patients ≥ 65 years old
    o Diagnosis of excessive supraventricular ectopy activity defined as ≥ 1% PAC / 24 h or any atrial runs ≥ 20 PACs on a 24-hour Holter ECG monitoring (the indication for the Holter will be let at the discretion of the doctor according to international guidelines indication)
    o High risk embolism defined by a CHA2DS2VASC score ≥ 3
    o Written consent from patient
    o Patients able to attend consultations and Cerebral MRI at baseline and 24 months at the participating centre.
    o Ability to understand and comply with the study protocol
    o Affiliation of social security regime
    E.4Principal exclusion criteria
    o According to the SmPC, any contraindication to Rivaroxaban (particularly patients with ongoing major bleeding, vascular complication, prior haemorrhagic stroke or over recent stroke) or one of its excipients.
    o Inability to perform cerebral MRI
    o Life expectancy <24 months
    o History of major hemorrhage after taking rivaroxaban
    o Documented atrial fibrillation or any other indication for oral anticoagulation
    o Patients with previous documented AF
    o Valvular congenital heart disease
    o Anticoagulant agents in the month prior to the inclusion visit
    o Acute coronary syndrome, coronary revascularization (percutaneous coronary intervention or coronary artery bypass surgery) or in the past 30 days
    o Requires long-term antiplatelet therapy other than aspirin (i.e., patient requires any platelet aggregation inhibitor in addition to study treatment, in particular, the combination of two platelet aggregation inhibitors)
    o Ongoing need for strong inhibitors of both CYP3A4 and P-glycoprotein (e.g., ketoconazole, itraconazole, ritonavir or clarithromycin)
    o Ongoing need for strong inducers of both CYP3A4 and P-glycoprotein (e.g., rifampin, carbamazepine, phenytoin)
    o Participants considered by the investigator to be unsuitable for the study for any of the following reasons:
     Patient refuse the treatment with rivaroxaban or anticipated to have poor compliance on study drug treatment
     Unwilling to attend study follow-up visits
    o cancer or other life threatening conditions
    o Severe, disabling stroke within the previous 6 months, or any stroke within the previous 14 days
    o Conditions associated with an increased risk of bleeding:
    a. Major surgery within the previous month
    b. Planned surgery or intervention within the next 3 months
    c. History of intracranial, intraocular, spinal, retroperitoneal or atraumatic intra‐articular bleeding
    d. Gastrointestinal hemorrhage within the past year
    e. Symptomatic or endoscopically documented gastroduodenal ulcer disease in the previous 30 days
    f. Hemorrhagic disorder or bleeding diathesis
    g. Need for anticoagulant treatment of disorders other than atrial fibrillation
    h. Fibrinolytic agents within 48 hours of study entry
    i. Uncontrolled hypertension (systolic blood pressure greater than 180 mm Hg and/or diastolic blood pressure greater than 100 mm Hg)
    j. Recent malignancy or radiation therapy (within 6 months) and not expected to survive 3 years
    o Severe renal impairment (estimated creatinine clearance <30 mL/min or less)
    o Active infective endocarditis
    o Active liver disease, including but not limited to, associated or not with coagulopathy and a clinically significant risk of bleeding, including cirrhotic patients with a Child Pugh class B or C score.
    o Persistent ALT, AST, Alk Phos greater than twice the upper limit of the normal range
    o Known active hepatitis C (positive HCV RNA)
    o Known active hepatitis B (HBs antigen +, anti HBc IgM +)
    o Known active hepatitis A
    o Anemia (hemoglobin level less than 110 g/L) or thrombocytopenia (platelet count less than 150 X 109/L)
    o Patients who have received an investigational drug in the past 30 days
    o Patients considered unreliable by the investigator, or having any condition which, in the opinion of the investigator, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse)
    o Patient with cardiac prosthetic devices : Reveal, pace-maker, automatic implantable defibrillator
    o Participation in another interventional clinical trial
    o Patient on AME (state medical aid)
    o Patient under legal protection
    o Prisoners.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the first ischemic stroke or peripheral embolism detected clinically and on systematic cerebral MRIs in a time-to-event analysis.
    The primary safety outcome is major bleeding at any site in the body according to the criteria of the International Society of Thrombosis and Hemostasis (ISTH)
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 months
    E.5.2Secondary end point(s)
    Secondary endpoints will include:
    - Efficacy-related endpoints:
    o A composite of ischemic stroke, peripheral embolism or major bleeding (net clinical benefit); a composite of death from cardiovascular causes, stroke, systemic embolism, myocardial infarction (major cardiovascular events); death from any cause; cognitive decline as assessed by the MMS (26).
    o Individual components of composite primary and secondary efficacy endpoints
    - Exploratory endpoints:
    o Incidence of documented atrial fibrillation diagnosed from patient symptoms or systematic 24 hours ECG Holter performed at 1- and 2-year follow-up.
    o Incidence of asymptomatic MRI-detected cerebral damage including silent cerebral ischemia and microbleeds at 2-year follow up.
    - Safety-related endpoints:
    o Life-threatening or fatal bleeding events, clinically relevant non-major bleeding intracranial hemorrhage and minor bleeding events. Bleeding severity will be assessed according to ISTH classification.
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 months
    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 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 Yes
    E.6.13.1Other scope of the trial description
    To reduce stroke with Rivaroxaban therapy
    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 No
    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 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 concerned17
    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
    Last Visit Last Subject
    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 months52
    E.8.9.1In the Member State concerned days22
    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.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 550
    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 state550
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 550
    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)
    Patient will revert to standard treatment of care
    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 Decision2022-07-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-14
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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