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    Summary
    EudraCT Number:2013-000046-19
    Sponsor's Protocol Code Number:RIVAROXHFA3001
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-05-12
    Trial results View 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 ConcernedUK - MHRA
    A.2EudraCT number2013-000046-19
    A.3Full title of the trial
    A Randomized, Double-blind, Event-driven, Multicenter Study Comparing the Efficacy and Safety of Oral Rivaroxaban with Placebo for Reducing the Risk of Death, Myocardial Infarction or Stroke in Subjects with Heart Failure and Significant Coronary Artery Disease Following an Episode of Decompensated Heart Failure
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Assess the Effectiveness and Safety of Rivaroxaban in Reducing the Risk of Death, Myocardial Infarction or Stroke in Participants with Heart Failure and Coronary Artery Disease Following an Episode of Decompensated Heart Failure
    A.3.2Name or abbreviated title of the trial where available
    COMMANDER HF Study
    A.4.1Sponsor's protocol code numberRIVAROXHFA3001
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation PlanP/134/2012
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen-Cilag International NV
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportJanssen Research & Development
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen Research and Development
    B.5.2Functional name of contact pointWilliam Byra, MD
    B.5.3 Address:
    B.5.3.1Street Address920 Route 202 South
    B.5.3.2Town/ cityRaritan, NJ
    B.5.3.3Post code08869
    B.5.3.4CountryUnited States
    B.5.4Telephone number011908927 3540
    B.5.6E-mailwbyra@its.jnj.com
    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
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Pharma AG
    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.3.1Product nameRivaroxaban
    D.3.2Product code JNJ-39039039/BAY 59-7939
    D.3.4Pharmaceutical form Film-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.3.9.2Current sponsor codeBAY 59-7939
    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 number2.5
    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 placeboFilm-coated 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
    Prevention of death, heart attack or stroke in patients with heart failure and significant coronary artery disease following an episode of decompensated HF (index event).
    E.1.1.1Medical condition in easily understood language
    Patients with heart failure following an index event.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10008908
    E.1.2Term Chronic heart failure
    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 is to demonstrate that rivaroxaban is superior to placebo in subjects with HF and significant CAD, who are receiving standard care, in reducing the risk of the composite of ACM, MI, or stroke following an index event.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to compare rivaroxaban with placebo in addition to standard care in subjects with HF and significant CAD following an index event in reducing the risk of the following outcomes:
    •Composite of cardiovascular mortality and re-hospitalization for worsening heart failure
    •Cardiovascular mortality
    •Re-hospitalization for worsening of heart failure
    •Re-hospitalization for cardiovascular events
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Must have symptomatic heart failure for at least 3 months prior to Screening
    - Participants must have an episode of decompensated heart failure (index event) requiring:
    a) an overnight stay [that is, staying past midnight] in a hospital, emergency department, or medical facility with the capability of treating with intravenous medications and observing heart failure patients before randomization or;
    b) an unscheduled outpatient visit to a heart failure management center, where parenteral therapy is required for heart failure stabilization. An episode of decompensated heart failure is defined as symptoms of worsening dyspnea or fatigue, objective signs of congestion such as peripheral edema or ascites, and/or adjustment of pre-hospitalization/outpatient visit heart failure medications. Participants are eligible for randomization at discharge from the facility treating the index event and up to 30 days after discharge if they are in stable condition
    - Must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40 percent (%) within 1 year before randomization
    - Must have evidence of significant coronary artery disease
    - Must be medically stable in terms of heart failure clinical status at the time of randomization
    - Subject must be receiving appropriate HF treatment at the appropriate dosing perguidelines such as Diuretic, Renin-angiotensin system (RAS) inhibitors such as an ACE inhibitor, or ARB, or vasodilator therapy such as hydralazine or nitrates if intolerant to ACE inhibitor and ARB, Beta blocker therapy, Aldosterone antagonist therapy
    - Subject must be receiving appropriate CAD treatment such as Aspirin (ASA) at a dose of 100 mg or less per day unless not clinically appropriate or Clopidogrel, ticlopidine, prasugrel and ticagrelor are the only other antiplatelet agents that may be used concomitantly if clinically indicated
    - Subject must have completed all prophylactic anticoagulation (such as enoxaparin, warfarin, heparin, etc) before randomization
    - Before randomization, a woman must be either Postmenopausal, defined as >45 years of age with amenorrhea for at least 18 months, or if menstruating and heterosexually active, practicing a highly effective method of birth control, including hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method [(eg, condoms, diaphragm, or cervical cap, with spermicidal foam, cream, or gel)], or male partner sterilization, consistent with local regulations regarding use of birth control methods for subjects participating in clinical studies, for the duration of their participation in the study, or Surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation,
    or otherwise be incapable of pregnancy), or not heterosexually active
    - A woman of childbearing potential must have a negative serum or urine pregnancy test before randomization occurs
    - A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control eg, either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm until the last dose of study drug.
    - Must have a brain natriuretic peptide (BNP) level greater than or equal to (>=) 200 picogram per milliliter (pg/ml) or N-terminal-proBNP (NT-proBNP) level >=800 pg/ml (preferred assay) during the Screening period and before randomization
    E.4Principal exclusion criteria
    - Any condition that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding, such as, but not limited to, active internal bleeding, clinically significant bleeding, bleeding at noncompressible site, or bleeding diathesis within 28 days of randomization, platelet count <90,000/μl at screening, history of intracranial hemorrhage, major surgery, biopsy of a parenchymal organ, or serious trauma (including head trauma) within 28 days before randomization, sustained uncontrolled hypertension; systolic blood pressure ≥180 mmHg or diastolic, blood pressure ≥100 mmHg,
    - Severe concomitant disease such as:
    Atrial fibrillation (AFib) or another condition that requires chronic anticoagulation (subjects with isolated transient AFib may be allowed at the discretion of the treating physician investigator), Documented acute MI during index event, Planned cardiac surgery within 28 days either prior to or after randomization, excluding PCIs and electrophysiologic devices, Implantation of an electrophysiologic device such as implantable cardioverter, defibrillator or pacemaker planned to occur within 14 days either prior to or after randomization, Planned cardiac transplantation or mechanical ventricular assist device implantation, Known history of severe valvular disease that is significantly contributing to the heart failure (eg, aortic stenosis with a gradient of >40 mmHg or mitral regurgitation with regurgitant fraction ≥60%), Chronic episodes of ventricular tachycardia (sustained > 30 seconds and any
    ventricular tachycardia associated with symptoms), Heart failure due to the following, causes: postpartum, infectious (eg, HIV, acute myocarditis), substance abuse (eg, cocaine), alcohol, infiltrative disease (eg, amyloidosis), or a transient reversible condition (eg, thyrotoxicosis, arrhythmia), Cardiogenic shock at the time of randomization, Estimated glomerular filtration rate (eGFR) <20 mL/min (MDRD method) at screening or if dialysis is anticipated within 6 months from screening, Active malignancy or other condition, other than underlying HF, limiting life expectancy to less than 6 months, Acute endocarditis, Currently treated with hemofiltration or dialysis, Known significant liver disease (eg, acute hepatitis, chronic active hepatitis, cirrhosis, hepatic disease which is associated with coagulopathy, moderate or severe hepatic impairment [corresponding to Child-Pugh B or C]), Anemia (ie, hemoglobin <8 g/dL) at screening, Known history of severe peptic ulcer disease (ie, history of at least 2 episodes of upper gastrointestinal bleeding), History of severe thrombocytopenia (platelet count < 50,000/l), Known clinical history of HIV
    - Prior stroke within 90 days of randomization
    - Has been hospitalized for longer than 21 days during the index event
    - Subject has known allergies, hypersensitivity, or intolerance to rivaroxaban or its excipients
    - Planned intermittent outpatient treatment with positive inotropic drugs administered intravenously
    - Subject has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 28 days before the planned first dose of study drug or is currently enrolled in an investigational study
    - Subject is a woman who is pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study
    - Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
    E.5 End points
    E.5.1Primary end point(s)
    - Time to the first occurence of any of the following: death from any cause, myocardial infarction, or stroke
    - Time to the first occurence of either fatal bleeding or bleeding into a critical space with potential for permanent disability
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Day 1 up to approximately Month 30
    - Day 1 up to approximately Month 30
    E.5.2Secondary end point(s)
    - Time to the first occurence of either death due to a cardiovascular cause or re-hospitalization for worsening of heart failure
    - Time to death due to a cardiovascular cause
    - Time to rehospitalization for worsening of heart failure
    - Time to rehospitalization for cardiovascular events
    - Bleeding requiring hospitalization
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Day 1 up to approximately Month 30
    - Day 1 up to approximately Month 30
    - Day 1 up to approximately Month 30
    - Day 1 up to approximately Month 30
    - Day 1 up to approximately Month 30
    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 Yes
    E.6.13.1Other scope of the trial description
    Biomarker analysis
    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 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) 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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA142
    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
    Argentina
    Australia
    Brazil
    Bulgaria
    Canada
    China
    Czech Republic
    France
    Germany
    Hungary
    Italy
    Japan
    Korea, Republic of
    Malaysia
    Mexico
    Netherlands
    Poland
    Romania
    Russian Federation
    Spain
    Turkey
    Ukraine
    United Kingdom
    United States
    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
    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 months30
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months30
    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: 1750
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3250
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 3100
    F.4.2.2In the whole clinical trial 5000
    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 Decision2015-07-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-05-02
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