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    Summary
    EudraCT Number:2010-021258-20
    Sponsor's Protocol Code Number:n.a.
    National Competent Authority:Czech Republic - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-09-19
    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 ConcernedCzech Republic - SUKL
    A.2EudraCT number2010-021258-20
    A.3Full title of the trial
    Early treatment of Atrial fibrillation for Stroke prevention Trial (EAST)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to demonstrate that an as early as possible treatment of atrial fibrillation can prevent a stroke.
    A.3.2Name or abbreviated title of the trial where available
    EAST
    A.4.1Sponsor's protocol code numbern.a.
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN04708680
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01288352
    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 SponsorKompetenznetz Vorhofflimmern e.V. (AFNET e.V.)
    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 supportKompetenznetz Vorhofflimmern e.V. (AFNET e.V.)
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKompetenznetz Vorhofflimmern e.V. (AFNET e.V.)
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressMendelstraße 11
    B.5.3.2Town/ cityMünster
    B.5.3.3Post code48149
    B.5.3.4CountryGermany
    B.5.4Telephone number+49251980 1340
    B.5.5Fax number+49251980 1349
    B.5.6E-mailinfo@kompetenznetz-vorhofflimmern.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.2.5The 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
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMP
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Information not present in EudraCT
    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, stroke, heart failure, myocardial infarction, cognitive dysfunction
    E.1.1.1Medical condition in easily understood language
    Atrial fibrillation is a common type of cardiac rhythm disorder, which represents an important cause for stroke but also for myocardial infarction and heart muscle weakness (heart failure).

    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 PT
    E.1.2Classification code 10003658
    E.1.2Term Atrial fibrillation
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level HLGT
    E.1.2Classification code 10019280
    E.1.2Term Heart failures
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10061256
    E.1.2Term Ischaemic stroke
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10028596
    E.1.2Term Myocardial infarction
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level HLGT
    E.1.2Classification code 10009841
    E.1.2Term Cognitive and attention disorders and disturbances
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10019016
    E.1.2Term Haemorrhagic stroke
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To test whether an early and comprehensive rhythm control therapy can prevent adverse cardiovascular outcomes in patients with atrial fibrillation (AF) compared to usual care.
    E.2.2Secondary objectives of the trial
    n.a.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Recent-onset AF (≤ 1 year prior to enrolment)
    2. At least one ECG within recent 12 months that documents AF whereas the AF episode must last longer than 30 s.
    3. EITHER
    one of the following:
    * age > 75 years or
    * prior stroke or transient ischemic attack
    OR
    two of the following:
    * age > 65 years,
    * female sex,
    * arterial hypertension (chronic treatment for hypertension, estimated need for continuous antihypertensive therapy or resting blood pressure > 145/90 mmHg),
    * diabetes mellitus
    * severe coronary artery disease (previous myocardial infarction, CABG or PCI)
    * stable heart failure (NYHA II or LVEF <50%),
    * left ventricular hypertrophy on echocardiography (more than 15 mm wall thickness),
    * chronic kidney disease (MDRD stage III or IV),
    * peripheral artery disease.

    4. Provision of signed informed consent
    5. Age ≥ 18 years.
    E.4Principal exclusion criteria
    1. Any disease that limits life expectancy to less than 1 year.
    2. Participation in another clinical trial, either within the past two months or ongoing
    3. Previous participation in the EAST trial.
    4. Pregnant women or women of childbearing potential not on adequate birth control: only women with a highly effective method of contraception [oral contraception or intra-uterine device (IUD)] or sterile women can be randomized.
    5. Breastfeeding women.
    6. Drug abuse.
    7. Prior AF ablation or surgical therapy of AF.
    8. Previous therapy failure on amiodarone, e.g. patients who suffered from symptomatic recurrent AF that required escalation of therapy while on amiodarone.
    9. Patients not suitable for rhythm control of AF.
    10. Severe mitral valve stenosis.
    11. Prosthetic mitral valve.
    12. Clinically relevant hepatic dysfunction requiring specific therapy.
    13. Clinically manifest thyroid dysfunction requiring therapy. After successful treatment of thyroid dysfunction, patients may be enrolled when their thyroid function is controlled.
    14. Severe renal dysfunction (stage V, requiring or almost requiring dialysis).
    E.5 End points
    E.5.1Primary end point(s)
    A composite of cardiovascular death, stroke, transitoric ischemic attack (TIA), and hospitalization due to worsening of heart failure or due to acute coronary syndrome.
    The first co-primary outcome parameter is defined as the time to the first occurrence of a composite of cardiovascular death, stroke / transient ischemic attack (TIA), and hospitalization due to worsening of heart failure or due to acute coronary.
    The second co-primary outcome parameter is nights spent in hospital per year.
    E.5.1.1Timepoint(s) of evaluation of this end point
    A first interim analysis is to be performed when the first 171 events in the 1st co-primary outcome have been observed. If the assumptions are met, this will happen 42 months after the first patient was randomized.
    The second interim analysis is to be performed when the first 343 events in the 1st co-primary outcome have been observed (approximately 61 months after the first patient was randomized).
    The third interim analysis is to be performed when the first 514 events have been observed (approximately 77 (11) months after the first (last) patient was randomized).
    The final analysis is to be performed when 685 events have been observed. If the assumptions are met, this will happen 95 (30) months after the first (last) patient was randomized.
    E.5.2Secondary end point(s)
    1. Cardiovascular death
    2. stroke
    3. worsening of heart failure assessed by hospitalizations
    4. acute coronary syndrome assessed by hospitalizations
    5. time to recurrent atrial fibrillation
    6. cardiovascular hospitalisations
    7. all-cause hospitalisations
    8. left ventricular function assessed by transthoracic echocardiography
    9. quality of life changes assessed by EQ-5D and SF-12
    10. cognitive function assessed by MoCA
    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluation of secondary end points no. 1-7 at the end of the trial (i.e. after 8 years).
    Evaluation of secondary end points no. 8-10 at month 24 after randomisation.
    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 No
    E.6.5Efficacy No
    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
    usual care as defined by the current ESC guidelines and including delayed rhythm control therapy
    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 EEA192
    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
    Belgium
    Czech Republic
    Denmark
    France
    Germany
    Italy
    Netherlands
    Poland
    Spain
    Switzerland
    United Kingdom
    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
    EAST is an event-driven trial. The final analysis will be performed if 685 events in the 1st co-primary outcome have been observed. If the statistical assumptions are met, this will happen approx. 8 years after the first patient has been randomised in the study. Thus a duration of the entire trial of around 8 years is expected. All patients will be followed-up until the end of the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months0
    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.1.1.2Preterm 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: 810
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1935
    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 2660
    F.4.2.2In the whole clinical trial 2745
    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)
    All medications and treatments used/applied during the EAST study are in-line therapies approved by health authorities and marketed. They are used in line with European approval and in line with the current guidelines. The patients' treatment after termination of the study participation will be decided by the responsible investigator and will be in accordance with local clinical routine.
    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 Decision2011-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-22
    P. End of Trial
    P.End of Trial StatusOngoing
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