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    Summary
    EudraCT Number:2021-002210-13
    Sponsor's Protocol Code Number:STARC210421
    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:2021-10-26
    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 number2021-002210-13
    A.3Full title of the trial
    Post-Operative Atrial Fibrillation after Surgical Aortic Valve Replacement and the influence of HMG-CoA reductase inhibitors
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Post-Operative Atrial Fibrillation after Surgical Aortic Valve Replacement and the influence of statin
    A.4.1Sponsor's protocol code numberSTARC210421
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05076019
    A.5.4Other Identifiers
    Name:US NCT - substudy 3Number:NCT05062239
    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 SponsorThe department of cardiac, thoracic and vascular surgery - Odense University Hospital
    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 department of cardiac, thoracic and vascular surgery - Odense University Hospital Denmark
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOdense University Hospital Denmark
    B.5.2Functional name of contact pointThe department of cardiac surgery
    B.5.3 Address:
    B.5.3.1Street AddressJ. B. Winsløwsvej 4, Indgang 20 Penthouse 2. sal
    B.5.3.2Town/ cityOdense C
    B.5.3.3Post code5000
    B.5.3.4CountryDenmark
    B.5.6E-mailLytfi.Krasniqi@rsyd.dk
    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 Trial 2: Lipistad, filmovertrukne tabletter Trial 3: All statins
    D.2.1.1.2Name of the Marketing Authorisation holderSTADA (for Lipistad - Trial 2)
    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 Film-coated 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 134523-00-5
    D.3.9.2Current sponsor codeAtorvastatin
    D.3.9.3Other descriptive nameStatin
    D.3.9.4EV Substance CodeSUB05600MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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.3.9.3Other descriptive nameROSUVASTATIN
    D.3.9.4EV Substance CodeSUB20634
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number80
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFLUVASTATIN
    D.3.9.1CAS number FLUVASTATIN
    D.3.9.2Current sponsor codeFLUVASTATIN
    D.3.9.3Other descriptive nameFLUVASTATIN
    D.3.9.4EV Substance CodeSUB07768MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number80
    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.3.9.3Other descriptive namePRAVASTATIN
    D.3.9.4EV Substance CodeSUB10004MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number80
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSimvastatin
    D.3.9.1CAS number Simvastatin
    D.3.9.2Current sponsor codeSimvastatin
    D.3.9.3Other descriptive nameSimvastatin
    D.3.9.4EV Substance CodeSUB10529MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number80
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLOVASTATIN
    D.3.9.1CAS number LOVASTATIN
    D.3.9.2Current sponsor codeLOVASTATIN
    D.3.9.3Other descriptive nameLOVASTATIN
    D.3.9.4EV Substance CodeSUB08604MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number80
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCERIVASTATIN
    D.3.9.1CAS number 145599-86-6
    D.3.9.2Current sponsor codeCERIVASTATIN
    D.3.9.3Other descriptive nameCERIVASTATIN
    D.3.9.4EV Substance CodeSUB07440MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number80
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCERIVASTATIN
    D.3.9.1CAS number 147511-69-1
    D.3.9.2Current sponsor codeCERIVASTATIN
    D.3.9.3Other descriptive namePITAVASTATIN
    D.3.9.4EV Substance CodeSUB21363
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number80
    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
    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
    Trial 2:
    Condition under investigation: Postoperative atrial fibrillation after surgical aortic valve replacement.
    In patients no prior usage of statins:
    14 days prior surgery to 30days after - Atorvastatin (Lipistad) 80mg vs placebo

    Trial 3:
    Condition under investigation: Postoperative atrial fibrillation after surgical aortic valve replacement.
    In patients with prior usage of statins
    Discontinuation of statin vs continuation up to 14 days prior surgery to 30days after
    E.1.1.1Medical condition in easily understood language
    The effects of statins on the development of postoperative atrial fibrillation in patients undergoing aortic valve replacement with surgical procedure.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10003660
    E.1.2Term Atrial fibrillation and flutter
    E.1.2System Organ Class 100000004849
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Trial 2:
    The primary objective of this study is to establish if prophylactic regime administration of Atorvastatin 80 mg daily dose P.O. (started at least 7 to 14 days before surgery and continued until the 30th post-operative day included) in patients undergoing elective solitary SAVR with bioprosthesis and are statin-naïve leads to a reduction in the incidence of POAF evaluated by Holter monitoring.

    Trial 3:
    The primary objective of study 3 is to investigate if discontinuance of statins in patients undergoing elective solitary SAVR with bioprosthesis with prior usage of statin the last 3 months and of at least 7 days is associated with risk of POAF or other complications including infections evaluated by Holter monitoring, clinical presentation and biochemical parameters.
    E.2.2Secondary objectives of the trial
    Trial 2:
    The secondary objectives are to evaluate if prophylactic regime administration of Atorvastatin affects:
    • Early (≤30 days) and intermediate (1 year) clinical outcomes as outlined under secondary endpoints.
    • Prior to discharge echocardiographic outcomes as outlined under section 6.3.
    • Length of hospital care or the need of readmission.


    Trial 3:
    The secondary objectives are to evaluate if discontinuance of statin is associated with:
    • Early (≤30 days) and intermediate (1 year) clinical outcomes as outlined under secondary endpoints.
    • Prior to discharge echocardiographic outcomes as outlined under secondary endpoints.
    • Length of hospital care or the need of readmission
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Trial 2
    Patients undergoing elective solitary SAVR with bioprosthesis
    Patients who are in sinus rhythm and not taking any anti-arrhythmic medication, other than beta-adrenergic blocking agents, at the time of surgery
    No prior use of statin the last 3 months and at least 7 days prior to the time of surgery
    Age >60 years
    Willingness and provision of informed consent to be randomized

    Trial 3
    Patients undergoing elective solitary SAVR with bioprosthesis
    Patients who are in sinus rhythm and not taking any anti-arrhythmic medication, other than beta-adrenergic blocking agents, at the time of surgery
    In treatment with statin in the past 3 months and of at least 7 days
    Age >60 years
    Willingness and provision of informed consent to be randomized
    E.4Principal exclusion criteria
    Trial 2:
    Prior history of atrial fibrillation
    Prior history of cardiac surgery
    Known adverse reaction to statin
    Hepatic dysfunction (Alanin-aminotransferase more than twice the upper limit)
    Creatinine >200 µmol/L
    Known intolerance to statins or history of muscle toxicity with statins

    Trial 3
    Prior history of atrial fibrillation
    Prior history of cardiac surgery
    Hepatic dysfunction (Alanin-aminotransferase more than twice the upper limit)
    Creatinine >200 µmol/L
    E.5 End points
    E.5.1Primary end point(s)
    Trial 2:
    Primary Outcome Measure:
    1.Number of Participants with POAF - In-hospital
    In-hospital POAF assessed by Holter monitoring.

    2.Number of Participants with POAF - Early
    Early assessed by anamnesis and electronic health record (EHR).

    3.Number of Participants with POAF - Intermediate
    Intermediate POAF assessed by anamnesis and EHR.


    Trial 3:
    Primary Outcome Measure:
    1.Number of Participants with POAF - In-hospital
    In-hospital POAF assessed by Holter monitoring.

    2.Number of Participants with POAF - Early
    Early assessed by anamnesis and electronic health record (EHR).

    3.Number of Participants with POAF - Intermediate
    Intermediate POAF assessed by anamnesis and EHR.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Trial2:
    1 [Time Frame: In-hospital up to 10 days]
    2 [Time Frame: Early (≤30 days) incidence of POAF]
    3 [Time Frame: Intermediate (1 year) incidence of POAF]


    Trial 3:
    1 [Time Frame: In-hospital up to 10 days.]
    2 [Time Frame: Early (≤30 days) incidence of POAF]
    3 [Time Frame: Intermediate (1 year) incidence of POAF]
    E.5.2Secondary end point(s)
    4) Rate of All-cause mortality - In-hospital
    To evaluate the effect of prophylactic regime administration of Atorvastatin on clinical outcomes.
    Number of deaths in each group.
    5) Rate of All-cause mortality - Early
    To evaluate the effect of prophylactic regime administration of Atorvastatin on clinical outcomes.
    Number of deaths in each group.
    6) Rate of All-cause mortality - intermediate
    To evaluate the effect of prophylactic regime administration of Atorvastatin on clinical outcomes.
    Number of deaths in each group.
    7) Myocardial injury - Tn
    Injury assessed by serial Troponin measurements. Unit:ng/l
    8) Myocardial injury - CKMB
    Injury assessed by serial CKMB measurements. Unit: μg/l.
    9) Stroke - Early
    Number of patients with stroke in each group.
    10) Stroke - Intermediate
    Number of patients with stroke in each group.
    11) Trans ischemic attack - Early
    Number of patients with trans ischemic attack in each group.
    12) Trans ischemic attack - Intermediate
    Number of patients with trans ischemic attack in each group.
    13) Myocardial infarction - Early
    Number of patients with Myocardial infarction in each group.
    14) Myocardial infarction - Intermediate
    Number of patients with Myocardial infarction in each group.
    15) Permanent pacemaker - Early
    Number of patients with Permanent pacemaker in each group.
    16) Permanent pacemaker – Intermediate
    Number of patients with Permanent pacemaker in each group.
    17) ICD implantation - Early
    Number of patients with ICD implantation in each group.
    18) ICD implantation - Intermediate
    Number of patients with ICD implantation in each group.
    19) Acute kidney injury - Early
    Number of patients with Acute kidney injury in each group.
    20) Acute kidney injury - Intermediate
    Number of patients with Acute kidney injury in each group.
    21) LVEF
    Describe echocardiography assessed differences in pre and postoperative measurements of LVEF(left ventricular ejection fraction) between groups. Unit: %
    22) Strain
    Describe echocardiography assessed differences in pre and postoperative measurements of Strain between groups.Unit: %

    23) Peak gradient
    Describe echocardiography assessed differences in pre and postoperative measurements of peak gradient between groups. Unit: mmHg
    24) Mean gradient
    Describe echocardiography assessed differences in pre and postoperative measurements of mean gradient between groups. Unit: mmHg
    25) TAPSE
    Describe echocardiography assessed differences in pre and postoperative measurements of TAPSE (tricuspid annular plane systolic excursion) between groups. Unit: mm
    26) Length of stay on ICU
    Length of stay on ICU after surgery. Unit: Days
    27) Length of stay in hospital
    Length of stay in hospital after surgery. Unit: Days
    E.5.2.1Timepoint(s) of evaluation of this end point
    Trial 2 and 3
    4. In hospital up to 10 days
    5. ≤30 days
    6. 1 year
    7. After surgery until discharge up to 10 days
    8. After surgery until discharge up to 10 days
    9. ≤30 days
    10. 1 year
    11. ≤30 days
    12. 1 year
    13. ≤30 days
    14. 1 year
    15. ≤30 days
    16. 1 year
    17. ≤30 days
    18. 1 year
    19. ≤30 days
    20. 1 year
    21. Before surgery compared to prior to discharge (3rd to 5th postoperative day)
    22. Before surgery comp. to prior to discharge (3rd to 5th postop. day)
    23. Before surgery comp. to prior to discharge (3rd to 5th postop. day)
    24. Before surgery comp. to prior to discharge (3rd to 5th postop. day)
    25. Before surgery comp. to prior to discharge (3rd to 5th postop. day)
    26. Day of surgery to the day of discharge from ICU
    27. Day of surgery to the day of discharge

    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 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 No
    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 Yes
    E.8.1.7.1Other trial design description
    Trial 2: Double blind, Trial 3: Open
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Trial 2: Placebo, Trial 3: discontinuation of medicin
    E.8.2.4Number of treatment arms in the trial2
    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 No
    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
    Trial 2: After 1 year of follow up from last enrolled subject. Total subjects: 266
    Trial 3: After 1 year of follow up from last enrolled subject. Total subjects: 100
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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: 366
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 366
    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 state366
    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)
    After trial end the patients will be followed up to 15-years through electronic health record.
    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 Decision2021-12-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-17
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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