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    Summary
    EudraCT Number:2009-011291-29
    Sponsor's Protocol Code Number:RACE 3
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2011-08-17
    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 ConcernedUK - MHRA
    A.2EudraCT number2009-011291-29
    A.3Full title of the trial
    Routine versus Aggressive Upstream Rhythm Control for Prevention of Early Atrial Fibrillation in Heart Failure: RACE 3
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    RACE 3 study: Intensive vs. usual rhythm control for atrial fibrillation.
    A.3.2Name or abbreviated title of the trial where available
    RACE 3 study: Intensive vs. usual rhythm control for AF, Version 1
    A.4.1Sponsor's protocol code numberRACE 3
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00877643
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorInteruniversity Cardiology Institute of the Netherlands (ICIN)
    B.1.3.4CountryNetherlands
    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 Interuniversity Cardiology Institute of the Netherlands (ICIN)
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportNetherlands Heart Foundation (NHS B 2008 035)
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportWorking group on Cardiovascular Research, the Netherlands
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportSanofi Aventis
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportBoehringer Ingelheim
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportMedtronic
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportBiotronik
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportSt Jude Medical
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportBoston Scientific
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportAstraZenenca
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBirmingham City Hospital
    B.5.2Functional name of contact pointprof. GYH Lip, Chief Investigator
    B.5.3 Address:
    B.5.3.1Street AddressDudley Road
    B.5.3.2Town/ cityBirmingham
    B.5.3.3Post codeB18 7QH
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01215075080
    B.5.5Fax number01215075907
    B.5.6E-mailg.y.h.lip@bham.ac.uk
    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 eplerenone
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameeplerenone
    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 INNeplerenone
    D.3.9.1CAS number 107724209
    D.3.9.2Current sponsor codeeplerenone
    D.3.9.4EV Substance CodeAS1
    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 spironolactone
    D.2.1.1.2Name of the Marketing Authorisation holderPharmacia Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameSpironolactone
    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 INNSpironolactone
    D.3.9.1CAS number 52-01-7
    D.3.9.2Current sponsor codeSpironolactone
    D.3.9.4EV Substance CodeAS4
    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: 3
    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 atorvastatin
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Ireland Pharmaceuticals
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 nameatorvastatin
    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 INNatorvastatin
    D.3.9.1CAS number 134523-03-8
    D.3.9.2Current sponsor codeatorvastatin
    D.3.9.4EV Substance CodeAS3
    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: 4
    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 Fluvastatin
    D.2.1.1.2Name of the Marketing Authorisation holderSandoz Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameFluvastatin
    D.3.4Pharmaceutical form Capsule
    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 INNFluvastatin
    D.3.9.1CAS number 93957-55-2
    D.3.9.4EV Substance CodeAS2
    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: 5
    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 Pravastatin
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharmaceuticals Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 namePravastatin
    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 INNpravastatin
    D.3.9.1CAS number 81093-37-0
    D.3.9.2Current sponsor codepravastatin
    D.3.9.4EV Substance CodeAS5
    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: 6
    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 rosuvastatin
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca UK Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 namerosuvastatin
    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 INNrosuvastatin
    D.3.9.1CAS number 287714-41-4
    D.3.9.2Current sponsor coderosuvastatin
    D.3.9.4EV Substance CodeAS6
    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: 7
    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 Simvastatin
    D.2.1.1.2Name of the Marketing Authorisation holderLupin (Europe) Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameSimvastatin
    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 INNsimvastatin
    D.3.9.1CAS number 79902-63-9
    D.3.9.2Current sponsor codesimvastatin
    D.3.9.4EV Substance CodeAS7
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    atrial fibrillation
    E.1.1.1Medical condition in easily understood language
    Heart rhythm disorder causing an irregular heart rhythm and usually an increased heart rate. Usual treatment involves a controlled electrical shock (ECV) and medication that lowers the heart rate.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10003661
    E.1.2Term Atrial fibrillation paroxysmal
    E.1.2System Organ Class 10007541 - Cardiac 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 principal objective of the RACE 3 study is to compare an ‘intensive’ (‘upstream’) treatment programme for atrial fibrillation patients undergoing electrical cardioversion (a controlled electric shock to the heart to convert the heart rhythm from atrial fibrillation to ‘normal’ sinus rhythm) for atrial fibrillation to those receiving usual (‘conventional’) care. The study will test if the ‘intensive’ treatment which consists of a combination of medication (including aldosterone receptor antagonists and cholesterol lowering drugs which are already widely used), lifestyle advice, and cardiac rehabilitation, in addition to electrical cardioversion, can improve the chances of the patients remaining in sinus rhythm one year after cardioversion, compared to people who only receive electrical cardioversion plus ‘conventional’ care for their atrial fibrillation. ‘Conventional’ treatment
    E.2.2Secondary objectives of the trial
    To investigate whether in patients with atrial fibrillation (AF) and a reduced pumping ability or filling capacity of the heart, an ‘intensive’ (‘upstream’) treatment which consists of a combination of medication (including aldosterone receptor antagonists and cholesterol lowering drugs which are already widely used), lifestyle advice, and cardiac rehabilitation, in addition to electrical cardioversion, can improve the chances of the patients remaining in ‘normal’ sinus rhythm without the need for class III antiarrhythmic drugs (e.g. amiodarone, effective drugs for preserving 'normal' sinus rhythm but with the potential of causing many kinds of adverse effects) or pulmonary vein isolation (invasive procedure for the treatment of atrial fibrillation)….
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    RACE 3: Routine versus Aggressive Upstream Rhythm Control for Prevention of Early Atrial Fibrillation in Heart Failure. Sub-study on genetic risk factors for Atrial Fibrillation Version 1, 15-3-2011 In this sub-study (for which patients have to fill in a separate consent form) it will be investigated whether certain genetic risk factors are associated with success of the ‘intensive’ therapy. Blood samples obtained specifically for this substudy will be used for the genetic analysis.
    E.3Principal inclusion criteria
    - Early symptomatic persistent AF defined as: 1. total AF history < 2 years, and 2. total persistent AF duration > 7 days and < 6 months, and 3. ≤ 1 previous ECV - Mild to moderate early HF, defined as: 1. Total HF history < 1 year, and 2. One of the following:  LVEF ≥ 45% and NYHA II-III, and normal pulmonary function and body mass •Previously documented HF-related NT-proBNP elevation (> 400 ng/l (=48 pmol/l)), or •Evidence of structural heart disease including LV hypertrophy (posterior wall and/or septum diameter ≥ 11 mm or ≥ 10 mm using Penn’s method as in MUMC) or regional LV dysfunction (akinesia, hypokinesia), or •Previous admission for HF, or •Evidence of diastolic dysfunction on echocardiography (average annular e’ <8 cm/s, ánd deceleration time > 220 ms, ánd average E/e’ > 8 or in case of color coded TDI E/e’ > 11)  LVEF 25-45% and NYHA class I-III - Optimal documentation and treatment of underlying heart disease; - No contra-indication for oral anticoagulation; - Eligible for cardiovascular rehabilitation program; - Age ≥ 40 years.
    E.4Principal exclusion criteria
    - On waiting list for PVI or expected to be placed on waiting list for PVI within one year; - Symptoms not allowing ECV to be delayed for 3 weeks; - HF NYHA functional class IV; - LVEF < 25%. - Left atrial size > 50 mm (parasternal axis); - Severe valvular disease (previous valve repair/replacement is permitted); - Present ARA use; - Patients with cardiac resynchronization therapy; - Previous use of continuous prophylactic class I or class III antiarrhythmic drugs (except for sotalol, which should be discontinued at inclusion and replaced with beta-blocker); - Postoperative AF; - Myocardial infarction within last 3 months; - Hypersensitivity against ARAs; - Uncontrolled hypertension, defined as systolic blood pressure > 160 mmHg and/or a diastolic blood pressure > 95 mmHg (anti-hypertensive treatment is allowed); - Unstable angina pectoris; - Open heart surgery within the last 3 months; - Serum potassium > 5 mmol/l; - Acute and reversible illnesses; - Acute and chronic infection; - Alcohol or drug abuse or a severe progressive extracardiac disease; - Untreated manifest and latent hyper- or hypothyroidism or < 3 months euthyroidism; - Moderate to severe renal insufficiency (creatinine clearance less than 50 ml/min); - Patients with liver cirrhosis (Child-Pugh class C) or repeated ALT/AST 1.5 times the upper limit or other significant liver disease; - Co-administration of strong CYP3A4 inhibitors (i.e. grapefruit juice, ketoconazol, itraconazol, posaconazol, voriconazol, claritromycine, erytromycine, telitromycine, indinavir, nelfinavir, ritonavir, saquinavir, HIV-protease inhibitors) or strong CYP3A4 inductors (i.e. carbamazepine, rifampicine, St John’s wort [St Janskruid]); - Pregnancy; - Complex congenital heart diseases. The only congenital heart diseases that can be included are atrial septal defect, ventricular septal defect, bicuspid aortic stenosis; - Patients unlikely to comply with the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Sinus rhythm after 1 year of follow-up, defined as sinus rhythm during ≥ 6/7th of assessable time of continuous 7 days Holter monitoring during the last week of the study, with the patient still receiving a rhythm control strategy according to the attending physician. Failure of fulfilling these requirements will be considered as therapy failure.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Preliminary open assessment of the primary endpoint will be conducted by an independent data monitoring committee after 100 patients have completed the protocol. This will be done in order to have the option to adapt the sample size if the incidence rates at the interim analyses of the two treatment arms are different than originally expected to find the predefined treatment effect. Final analysis of the primary endpoint will be performed after the study has ended.
    E.5.2Secondary end point(s)
    1. Sinus rhythm on end of study ECG; 2. Sinus rhythm after 1 year of follow-up without the need for class III ion-channel antiarrhythmic drugs; 3. Sinus rhythm after 1 year of follow-up without the need for pulmonary vein isolation; 4. Permanent atrial fibrillation; 5. Number of electrical cardioversions; 6. Number of RF ablations; 7. AV node ablation; 8. Left ventricular function (systolic and diastolic function, left ventricular ejection fraction); 9. Exercise capacity; 10. Hospitalizations for heart failure; 11. Hospitalizations for other cardiovascular reasons including stroke, emboli, bleeding, myocardial infarction, PCI, CABG, life threatening arrhythmias, pacemaker or ICD/CRT(-D) therapy; 12. Mortality (i.e. non-cardiovascular death, cardiovascular death including cardiac [sudden and non-sudden], vascular [sudden and non-sudden]; 13. Biomarkers (i.e. markers of collagen/collagen metabolism, inflammatory mediators, thrombotic markers, neurohumoral factors, proteomic profiles) and genetics; 14. Quality of life; 15. Costs and cost-effectiveness.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Unless stated otherwise, all secondary analyses will be performed using the same patients included in the primary analysis, after the study has ended.
    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 No
    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
    Conventional rhythm control therapy for atrial fibrillation
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA19
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days11
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 250
    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)
    At the end of the trial it is possible to continue upstream medication if the trial has positive results, since statins and aldosterone antagonists are widely used and can be prescribed by any physician. This does not require specific arrangements. No arrangements have been made to continue the counseling visits in which upstream patients participate.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation The Interuniversity Cardiology Institute of the Netherlands (ICIN)
    G.4.3.4Network Country Netherlands
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-08-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-03
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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