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    Summary
    EudraCT Number:2018-000484-86
    Sponsor's Protocol Code Number:02022018
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2018-10-16
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2018-000484-86
    A.3Full title of the trial
    DAN-WAR-D
    Danish Warfarin-Dialysis Study
    Safety and efficacy of warfarin in patients with atrial fibrillation on dialysis -
    A nationwide parallel-group open randomized clinical trial
    DAN-WAR-D
    Danish Warfarin-Dialysis Study
    Blodfortyndende behandling til forebyggelse af slagtilfælde hos patienter med dialysekrævende kronisk nyresvigt og forkammerflimren: Et nationalt lodtrækningsforsøg
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    DAN-WAR-D
    Danish Warfarin-Dialysis Study
    Anticoagulation for prevention of stroke in patients with end-stage renal disease on dialysis with atrial fibrillation:
    A national randomized trial
    DAN-WAR-D
    Danish Warfarin-Dialysis Study
    Blodfortyndende behandling til forebyggelse af slagtilfælde hos patienter med dialysekrævende kronisk nyresvigt og forkammerflimren:
    Et nationalt lodtrækningsforsøg
    A.3.2Name or abbreviated title of the trial where available
    DAN-WAR-D - Danish Warfarin-Dialysis Study
    A.4.1Sponsor's protocol code number02022018
    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 SponsorRigshospitalet
    B.1.3.4CountryDenmark
    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 supportThe Danish Heart Foundation
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRigshospitalet
    B.5.2Functional name of contact pointDepartment of Nephrology
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamsvej 9
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4535453545
    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.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.4Pharmaceutical form 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 INNWARFARIN
    D.3.9.1CAS number 81-81-2
    D.3.9.4EV Substance CodeSUB00090MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2.5 to 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Atrial fibrillation, end-stage renal disease, and stroke
    Atrieflimmer, kronisk nyresvigt og apopleksi
    E.1.1.1Medical condition in easily understood language
    Atrial fibrillation, renal failure, and stroke
    Forkammerflimren, kronisk nyresvigt, og blodprop i hjernen
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10016149
    E.1.2Term Failure kidney
    E.1.2System Organ Class 100000004857
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10016566
    E.1.2Term Fibrillation atrial
    E.1.2System Organ Class 100000004849
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.1
    E.1.2Level LLT
    E.1.2Classification code 10057613
    E.1.2Term Thromboembolic stroke
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of the following parallel-group open randomized clinical trial presents a nationwide study aimed at investigating the benefit, tolerability, and safety of initiating warfarin versus no treatment in patients with atrial fibrillation on dialysis. The anticipated results from this project will provide conclusive evidence as to the appropriateness of initiating oral anticoagulation for stroke risk reduction in dialysis populations with atrial fibrillation with direct effects on clinical management and international guidelines pertaining to these patients.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients ≥18 years on chronic dialysis due to end-stage renal disease with de novo diagnosis of non-valvular paroxysmal, persistent, or permanent atrial fibrillation OR non-treated (for >2 months) prevalent paroxysmal, persistent or permanent atrial fibrillation as documented by an electrocardiogram or an episode of ≥30 seconds on Holter monitor, or episodes ≥ 6 minutes on event recorders or any other recording device.
    2. Competence to understand the study rational, including potential risks and benefits associated with treatment, necessary for written informed consent.
    E.4Principal exclusion criteria
    1. CHA2DS2-VASc Score ≤1
    2. Other indications for oral anticoagulation treatment (pulmonary embolism < 6months, deep vein thrombosis
    <3months, prior atrial fibrillation, mechanical heart valve prosthesis) - irrespective of whether treatment is
    implemented
    3. Ongoing dual antiplatelet treatment
    4. Malignancy (with exception of non-melanoma skin cancer) with recent < 1 year, ongoing, or planned curative,
    or palliative chemo- , radiation-, and/or scheduled surgical therapy
    5. Endoscopy with gastrointestinal ulcer <1 month
    6. Esophageal varices
    7. Autuimmune og genetic coagulation disorders
    8. Congenital alactasia, Lapp Lactase deficiency or glucose-galactose malabsorption
    9. Pending spinal tap
    10. Cerebrovascular malformations
    11. Arterial aneurisms
    12. Ulcers or wounds (Wagner grad >1)
    13. Bacterial endocarditis < 3 months
    14. Active bleeding contraindicating anticoagulation
    15. Any non-elective and/or non-ambulant surgery <7 days
    16. Cerebral hemorrhage <4 weeks
    17. Thrombocytopenia (platelet count <100 × 109/L) <30 days.
    18. Severe liver insufficiency (spontaneous international normalized ratio >1.5) <30 days.
    19. Known intolerance to warfarin
    20. Use of hypericum perforatum / St. John’s Wort
    21. Uncontrolled hypertension (repeat blood pressure >180/110mmhg) < 30 days
    22. Uncontrolled hyperthyroidism (thyroid-stimulating hormone <0.1μIU/mL) <30 days
    23. Pregnancy or lactation
    24. Participation in other ongoing intervention trials adjudged to influence study outcomes
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy outcome: Ischemic stroke or death due to ischemic or unspecified stroke
    Primary safety outcome: Major bleeding defined in accordance with the International Society on Thrombosis and Hemostasis definition pertaining to major bleeding in non-surgical patients, i.e. major intracranial, intraspinal, intraocular, retroperitoneal, intraarticular, pericardial, intramuscular with compartment syndrome, or gastrointestinal bleeding.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Study end will be defined as one year after ultimate randomization. A preplanned analysis of outcome by allocated treatment is proposed at study end.
    E.5.2Secondary end point(s)
    Secondary outcomes; non-fatal and fatal ischemic stroke, non-fatal and fatal hemorrhagic stroke, non-fatal and fatal ischemic or hemorrhagic stroke, discontinuation of the allocated randomized therapy, calciphylaxis, arteriovenous fistula thrombosis, fatal or non-fatal acute myocardial infarction, hospitalization due to left-sided heart failure, peripheral artery disease, arteriovenous fistula thrombosis, osteoporosis, all-cause mortality, and the combination of any non-fatal stroke and all-cause mortality, and the combination of any non-fatal stroke, any non-fatal major bleeding, and all-cause mortality.

    Tertiary outcomes: Alopecia and dermal necrosis.

    Additionally, the time in therapeutic range adjudged by international normalized ratios will be evaluated amongst patients treated with warfarin.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Study end will be defined as one year after ultimate randomization. A preplanned analysis of outcome by allocated treatment is proposed at study end.
    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
    no treatment
    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 concerned1
    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
    Study end will be defined as one year after ultimate randomization.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 600
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    patients with end-stage renal disease on dialysis
    F.4 Planned number of subjects to be included
    F.4.1In the member state800
    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)
    Patients will be informed of study end by the local primary investigator. As patients will be receiving warfarin therapy in accordance with the approved indication and the summary of product characteristics, no formal instructions on patient management beyond existing guidelines are proposed. As such, the decision to continue or discontinue treatment with warfarin beyond study completion will be at the discretion of the onsite investigators.
    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 Decision2019-01-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-12
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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