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    Summary
    EudraCT Number:2013-005364-26
    Sponsor's Protocol Code Number:RE-LATED-AF
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-04-28
    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 ConcernedGermany - BfArM
    A.2EudraCT number2013-005364-26
    A.3Full title of the trial
    Resolution of Left Atrial-Appendage Thrombus – Effects of Dabigatran in patients with AF (RE-LATED AF) – A Prospective, multicenter, randomized, open-label, controlled, explorative, blinded-endpoint (PROBE) trial to compare the efficacy of Dabigatran (150 mg bid) with Phenprocoumon for the resolution of left atrial appendage thrombus formation in patients with atrial fibrillation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Resolution of Left Atrial-Appendage Thrombus – Effects of Dabigatran in patients with AF
    A.3.2Name or abbreviated title of the trial where available
    RE-LATED-AF
    A.4.1Sponsor's protocol code numberRE-LATED-AF
    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 SponsorUniversity Medical Center of the Johannes Gutenberg University Mainz
    B.1.3.4CountryGermany
    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 supportBoehringer Ingelheim Pharma GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center of the Johannes Gutenberg University Mainz
    B.5.2Functional name of contact pointThomas Rostock
    B.5.3 Address:
    B.5.3.1Street AddressLangenbeckstr. 1
    B.5.3.2Town/ cityMainz
    B.5.3.3Post codeD-55131
    B.5.3.4CountryGermany
    B.5.4Telephone number00496131173696
    B.5.5Fax number00496131178487
    B.5.6E-mailthomas.rostock@unimedizin-mainz.de
    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 Pradaxa® 150 mg Hartkapseln
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    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 namePradaxa® 150 mg Hartkapseln
    D.3.2Product code B01AE07
    D.3.4Pharmaceutical form Capsule, hard
    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 INNDabigatran etexilate mesylate
    D.3.9.1CAS number 211914-51-1
    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 number150
    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 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 Marcumar
    D.2.1.1.2Name of the Marketing Authorisation holderMEDA Pharma GmbH & Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameMarcumar
    D.3.2Product code B01AA04
    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 INNPhenprocoumon
    D.3.9.1CAS number 435-97-2
    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 number3
    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
    Left atrial-appendage thrombus in atrial fibrillation
    Thrombus im linken Herzohr bei Patienten mit Vorhofflimmern
    E.1.1.1Medical condition in easily understood language
    thrombus in atrial fibrillation
    Thrombus bei Patienten mit Vorhofflimmern
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess whether Dabigatran leads to a faster complete LAA thrombus resolution as compared to Phenprocoumon.
    E.2.2Secondary objectives of the trial
    To assess the impact of Dabigatran on
    - complete LAA thrombus resolution rate until week 6
    - change in LAA thrombus size under treatment

    To assess and compare safety and tolerability of Dabigatran and Phenprocoumon
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients with documented non-valvular AF or atrial flutter (12-lead ECG)
    - Newly diagnosed or confirmed LAA thrombus in TEE (time of detection less than 28 days)
    - Patients >/= 18 years old
    - CHA2DS2-VASc Score >/= 1
    - CrCL >/= 30 mL/min (Cockcroft-Gault)
    - Women with childbearing potential have to practice a medically accepted contraception during the trial and a negative pregnancy test (serum and urine) should be existent before trial onset. In case of Phenprocoumon as study medication a reliable contraception has to be continued three month after last intake of Phenprocoumon, due to the teratogenic potential of Marcumar®. Reliable contraceptive methods are systematic contraceptives (oral, implant,
    injection) and diaphragm or condoms with a spermicide. Women that are sterile by surgery or for more than two years postmenopausal can participate in the trial.
    - Ability of patient to understand the character and the individual consequences of the clinical trial
    - Signed and dated informed consent before start of any specific trial procedures
    E.4Principal exclusion criteria
    - Patients > 80 years
    - Low body weight (< 50 kg)
    - Previous failure of LAA thrombus resolution with a VKA or factor Xa antagonist
    - Occurrence of LAA thrombus under long-term treatment (> 3 months) with vitamin K
    antagonists with an exception in the case of continued INR out of the target range
    - Contraindications for oral anticoagulation therapy
    (see current Fachinformation for Pradaxa® (150 mg) and Marcumar® (3 mg))
    - History of heart valve disorder (i.e., prosthetic valve or hemodynamically relevant valve disease)
    - Valvular heart disease requiring intervention (including mechanical valves)
    - Acute myocardial infarction or MI within the last 26 weeks
    - Acute coronary syndrome (e.g. instable angina pectoris, STEMI, NSTEMI)
    - Chronic Heart Failure (> NYHA IIIa)
    - Previous haemorrhagic stroke
    - TIA within the last 90 days
    - Clinical relevant bleeding within the last 26 weeks
    - Acute and subacute bacterial endocarditis
    - Recurrent pulmonary embolism
    - Esophagitis, gastritis and gastroesophageal reflux
    - Thrombocytopenia or functional platelet defects
    - Congenital or acquired coagulation or haemorrhagic disorders
    - Liver diseases (liver enzymes >2 ULN)
    - Renal insufficiency (CrCL below 30 mL/min)
    - Pre-treatment with Dabigatran in doses higher than 110 mg bid
    - Concomitant treatment with rivaroxaban, apixaban, and in case of approval during the course of the trial, also edoxaban
    - Concomitant treatment with irreversible cyclooxygenase inhibitors (e.g. ASA) at doses
    > 100 mg/d.
    - Concomitant treatment with high doses of Adenosine diphosphate (ADP) receptor
    inhibitors (e.g. clopidogrel) at doses > 75 mg/d
    - Combined treatment with Adenosine diphosphate (ADP) receptor inhibitors
    (e.g. clopidogrel) and irreversible cyclooxygenase inhibitors (e.g. ASA) in any dose
    combination
    - Planned treatment with long-term oral anticoagulants for alternative indications
    - Concomitant treatment with P-glycoprotein (P-gp) inhibitors, i.e. verapamil.
    - Need for continued treatment with ticlopidine, ticagrelor, prasugrel, systemic
    ketoconazole, itraconazole, posaconazole, cyclosporine, tacrolimus, dronedarone,
    rifampicin, phenytoin, carbamazepine, St. John’s Wort or any cytotoxic/
    myelosuppressive therapy
    - Concomitant treatment with medication not permitted (see chapter 5.2)
    - Planned surgical intervention during expected study participation or
    previous surgical interventions within the last 30 days
    - Other significant risk factors for bleeding complications (e.g. malignancy)
    - Pregnancy and lactation.
    - History of hypersensitivity to the investigational medicinal product or to any drug with
    similar chemical structure or to any excipient present in the pharmaceutical form of the
    investigational medicinal product.
    - Participation in other clinical trials during the present clinical trial or within the last
    90 days.
    - Medical or psychological condition that would not permit completion of the trial or signing
    of informed consent.
    E.5 End points
    E.5.1Primary end point(s)
    Time to complete LAA thrombus resolution
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 3
    week 4
    week 6
    E.5.2Secondary end point(s)
    - Complete LAA thrombus resolution until week 6 (yes/no)
    - Change in LAA thrombus size under treatment
    - Occurrence of any adverse event
    - Occurrence of major bleedings (see chapter 8.9.1)
    - Occurrence of strokes (all-type, haemorrhagic, ischemic) ascertained by CCT or cMRT
    - Occurrence of TIAs
    - Occurrence of cardiovascular events requiring hospitalization (e.g. myocardial infarction,
    acute coronary syndrome, severe tachyarrhythmia)
    - Occurrence of other thromboembolic events (e.g. deep vein thrombosis, pulmonary embolism)
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 3
    week 4
    week 6
    week 7
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 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 concerned14
    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 years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state110
    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)
    Subsequent treatment will be according to the individual needs of each patient. A variety of medication or medical intervention is possible. Regarding subsequent OAC treatment see also the current Fachinformation for Pradaxa® (150 mg) or Marcumar® (3 mg). Anticoagulation regimen after study completion will be performed at the discretion of the treating physician. Information on study treatment will be provided by the local study center from the time of randomization since the trial is open.
    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 Decision2014-06-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-05-22
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