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    Summary
    EudraCT Number:2020-000353-26
    Sponsor's Protocol Code Number:29BRC23.0017
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-01-31
    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 number2020-000353-26
    A.3Full title of the trial
    Clinical Surveillance vs. Anticoagulation for Low-risk Patients with Isolated Subsegmental Pulmonary Embolism: A Multicenter Randomized Placebo-Controlled Non-Inferiority Trial
    Surveillance clinique versus anticoagulation chez les patients à faible risque souffrant d'embolie pulmonaire sous-segmentaire isolée : essai randomisé, multicentrique, de non-infériorités, contrôlé par placebo (SAFE-SSPE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical Surveillance vs. Anticoagulation for Low-risk Patients with Isolated Subsegmental Pulmonary Embolism: A Multicenter Randomized Placebo-Controlled Non-Inferiority Trial
    Surveillance clinique versus anticoagulation chez les patients à faible risque souffrant d'embolie pulmonaire sous-segmentaire isolée : essai randomisé, multicentrique, de non-infériorités, contrôlé par placebo (SAFE-SSPE)
    A.3.2Name or abbreviated title of the trial where available
    SAFE-SSPE
    A.4.1Sponsor's protocol code number29BRC23.0017
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04263038
    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 SponsorBern University Hospital
    B.1.3.4CountrySwitzerland
    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 supportSwiss National Science Foundation
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportBayer AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Brest
    B.5.2Functional name of contact pointRachel VERDET
    B.5.3 Address:
    B.5.3.1Street Address2 avenue Foch
    B.5.3.2Town/ cityBrest cedex
    B.5.3.3Post code29609
    B.5.3.4CountryFrance
    B.5.4Telephone number0033229020090
    B.5.6E-mailrachel.verdet@chu-brest.fr
    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 Yes
    D.2.1.1.1Trade name Xarelto (Rivaroxaban)
    D.2.1.1.2Name of the Marketing Authorisation holderBayer AG
    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 nameRivaroxaban
    D.3.2Product code Rivaroxaban
    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 Yes
    D.3.11.13.1Other medicinal product typedirect factor Xa inhibitor
    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 placeboTablet
    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
    Isolated subsegmental pulmonary embolism
    E.1.1.1Medical condition in easily understood language
    Small blood clots in the pulmonary arteries, so called isloated pulmonary embolism.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10037377
    E.1.2Term Pulmonary embolism
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal 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 overall objective of this trial will be to evaluate the efficacy and safety of clinical surveillance without anticoagulation in low-risk patients with isolated SSPE.
    Objective 1: To compare the frequency of symptomatic, recurrent venous thromboembolism (VTE) in low-risk patients with isolated SSPE randomized to receive clinical surveillance or anticoagulation.
    E.2.2Secondary objectives of the trial
    Objective 2: To compare the frequency of clinically significant bleeding and all-cause mortality in low-risk patients with isolated SSPE randomized to receive clinical surveillance or anticoagulation.
    Objective 3: To compare health-related quality of life, functional status, and medical resource utilization in low-risk patients with isolated SSPE randomized to receive clinical surveillance or anticoagulation.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Informed Consent as documented by signature
    2) Age ≥18 years
    3) Objective diagnosis of symptomatic or asymptomatic isolated SSPE
    E.4Principal exclusion criteria
    1) Presence of leg DVT or upper extremity DVT (subclavian vein or above)
    2) Active cancer, defined as cancer treated with surgery, chemotherapy, radiotherapy, or palliative care during the last 6 months; or presence of metastatic cancer
    3) ≥1 prior episode of unprovoked VTE (absence of a transient or permanent risk factor)
    4) Clinical instability (systolic blood pressure <100 mm Hg or arterial oxygen saturation <92% at ambient air) at the time of presentation
    5) Active bleeding or at high risk of bleeding
    6) Severe renal failure (creatinine clearance <30ml/min)
    7) Severe liver insufficiency (Child-Pugh B or C)
    8) Concomitant use of strong CYP3A4 inhibitors or strong CYP3A4 inducers
    9) Known hypersensitivity to rivaroxaban
    10) Need for therapeutic anticoagulation for another reason
    11) Therapeutic anticoagulation for >72 hours for any reason at the time of screening
    12) Hospitalized for >72 hours prior to the diagnosis of isolated SSPE (hospital-acquired VTE)
    13) Known pregnancy or breast feeding (pregnancy test to be performed for women of childbearing potential)
    14) Lack of safe contraception in women of childbearing potential
    15) Refusal or inability to provide informed consent
    16) Prior enrolment in this trial
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome will be the proportion of recurrent, clinically symptomatic, objectively confirmed VTE within 90 days of randomization, defined as recurrent fatal or nonfatal pulmonary embolism (PE) or lower limb deep vein thrombosis (DVT; efficacy).

    E.5.1.1Timepoint(s) of evaluation of this end point
    day 90
    E.5.2Secondary end point(s)
    The secondary outcomes will be the proportion of clinically significant bleeding and all-cause mortality at 90 days of randomization (safety).
    The ancillary outcomes will be health-related quality of life, functional status, and medical resource utilization at 90 days of randomization. In a post-hoc analysis, we will also assess radiological inter-observer agreement for SSPE.
    E.5.2.1Timepoint(s) of evaluation of this end point
    day 90
    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 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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Anticoagulation with Rivaroxaban
    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 concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Switzerland
    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 of the last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months10
    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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 156
    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 No
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 86
    F.4.2.2In the whole clinical trial 276
    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 Decision2023-02-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-03-21
    P. End of Trial
    P.End of Trial StatusOngoing
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