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    Summary
    EudraCT Number:2006-003119-35
    Sponsor's Protocol Code Number:01
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2006-10-11
    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 ConcernedAustria - BASG
    A.2EudraCT number2006-003119-35
    A.3Full title of the trial
    Effects of simvastatin in patients after cardioversion (SIPAC) of non valvular atrial fibrillation
    A.3.2Name or abbreviated title of the trial where available
    The AF Prophylaxis Trial
    A.4.1Sponsor's protocol code number01
    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 SponsorMedical University of Vienna, Department of Clinical Pharmacology
    B.1.3.4CountryAustria
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Zocord
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp and Dome
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameZocord
    D.3.2Product code n.a.
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboTablet
    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
    patients after successful cardioversion of atrial fibrillation
    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 investigate the effects of statin treatment on (hs)-CRP-levels
    E.2.2Secondary objectives of the trial
    To investigate the effects of statin treatment on the following:
    -Recurrence rate and time to recurrence of AF
    -Established risk markers including lipid subfractions and other biomarkers of cardiovascular risk in AF (such as von Willebrand factor, adhesion molecules, etc.)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Age>18yrs
    -At least second episode of non valvular, persistent, symptomatic AF within one year, defined by an echocardiogram asserting non valvular origin and a duration of at least 12 hours.
    -Patient willing to undergo cardioversion if no spontaneous conversion to sinus
    rhythm occurs within 12 hours
    -Written informed consent
    E.4Principal exclusion criteria
    -First episode of AF
    -Last episode longer than a year ago

    -Termination within 12 hours
    -Transient atrial fibrillation caused by known reversible disorders (thyrotoxicosis, alcohol intoxication etc.)
    -Known refractoriness to cardioversion (after several trials, permanent AF)
    -Severe valvular heart disease
    -Current atrial myxoma or left ventricular thrombus
    -Left Ventricular Ejection Fraction < 30%
    -Severe rhythmological disorders other than AF (WPW-Syndrome, AV block II-III etc)
    - Prolonged QT interval (QTc interval of >500ms)
    -Stroke within the previous 30 days or transient ischaemic attack within 3 days
    -Treatment with fibrinolytic agents within 30 days before randomisation
    -History of intracranial, intraocular, spinal, retroperitoneal, overt gastrointestinal or atraumatic intra-articular bleeding during the last year
    -Endoscopically verified ulcer disease in the previous 30 days
    -Major surgical procedure or trauma in the previous 30 days
    -Planned major surgery
    -Haemorrhagic disorder
    -Admission for acute coronary syndrome or percutaneous coronary intervention within 30 days
    -Persistent blood pressure 180/100 mm Hg or greater with or without antihypertensive treatment
    -Need for regular use of non-steroidal anti-inflammatory at anti-inflammatory doses
    -Renal insufficiency (calculated creatinine clearance <30 mL/min)
    -Creatinine level of more than 2.5 mg per deciliter
    -Known severe hepatic disorders or persistent elevation of liver enzymes of more than two times the upper limit of normal
    -Unexplained elevation in the creatine kinase level more than three times the upper limit of normal
    -Women with child bearing potential
    -Drug addiction, alcohol abuse
    -Anaemia (haemoglobin <100 g/L or platelet count <100x109/L)
    -Abnormal electrolytes despite adequate therapy (especially potassium <3.5 or >5 mmol/L)
    -Estimated life expectancy <2 years
    -Already receiving statin therapy and need for statin therapy
    -Explicit need for statin therapy: Persons with established CHD or CHD risk equivalent (i.e. PAD or diabetes mellitus), who have a baseline LDL cholesterol ≥130 mg/dL
    -Known hypersensitivity to statins
    -Lipid-lowering therapy with fibric acid derivatives or niacin that cannot be discontinued before randomization,
    -Drugs that are strong inhibitors of cytochrome P-450 3A4 within the month before randomization or patients likely to require such treatment during the study period (because simvastatin is metabolized by this pathway)
    E.5 End points
    E.5.1Primary end point(s)
    (hs)-CRP levels
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 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.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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 Decision2006-11-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-09-12
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2008-10-03
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