Clinical trial • Not applicable • Cardiology
DRONEDARONE HYDROCHLORIDE for Acute ischemic stroke | Atrial fibrillation
Not applicable trial of DRONEDARONE HYDROCHLORIDE for Acute ischemic stroke | Atrial fibrillation.
Overview
- Trial Therapeutic Area
- Cardiology
- Trial Disease
- Acute ischemic stroke | Atrial fibrillation
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 28-05-2025
- First CTIS Authorization Date
- 11-09-2025
Trial design
Randomised, usual care alone; comparator arm is usual care + early rhythm-control therapy (early rhythm-control may use authorised antiarrhythmic drugs listed in the trial such as dronedarone, propafenone, amiodarone, flecainide). doses and schedules not specified in the public summary. Not applicable trial in Germany, Netherlands, Spain.
- Randomised
- Yes
- Comparator
- Usual care alone; comparator arm is usual care + early rhythm-control therapy (early rhythm-control may use authorised antiarrhythmic drugs listed in the trial such as dronedarone, propafenone, amiodarone, flecainide). Doses and schedules not specified in the public summary.
- Target Sample Size
- 711
- Trial Duration For Participant
- 730
Eligibility
Recruits 711 Vulnerable population selected. Written informed consent is required. Subject information and informed consent forms include versions for patients and for legal representatives and subsequent consent (documents listed in the trial record, e.g. L1_DE_SIS and ICF_D2_Legal Representative_Subsequent Consent_de; L1_DE_SIS and ICF_B_Legal Representative_de; L1_DE_SIS and ICF_C_Investigator_de; language-specific ICFs for DE, NL, ES)..
- Vulnerable Population
- Vulnerable population selected. Written informed consent is required. Subject information and informed consent forms include versions for patients and for legal representatives and subsequent consent (documents listed in the trial record, e.g. L1_DE_SIS and ICF_D2_Legal Representative_Subsequent Consent_de; L1_DE_SIS and ICF_B_Legal Representative_de; L1_DE_SIS and ICF_C_Investigator_de; language-specific ICFs for DE, NL, ES).
Inclusion criteria
- {"criterion_text":"- Acute ischemic stroke confirmed with standard of care brain imaging or clinical diagnosis\n- Randomisation within 4 weeks of stroke (but as early as possible)\n- AF first detected ≤1 year before randomisation (including paroxysmal AF)\n- At least one ECG within recent 12 months that documents AF\n- Age >45 years\n- Written informed consent"}
Exclusion criteria
- {"criterion_text":"- End-stage cancer or life-expectancy <12 months\n- Prior AF ablation or surgical therapy for AF\n- Patients not suitable for early rhythm control of AF\n- History of AF first diagnosed >12 months prior to randomization"}
Endpoints
Primary endpoints
- {"endpoint_text":"- A composite of first recurrent ischaemic stroke, haemorrhagic stroke, unclassified stroke, cardiovascular death, or hospitaliza-tion due to worsening of heart failure or due to acute coronary syndrome (ACS), analysed as time to the first occurrence of one of the aforementioned components.","definition_or_measurement_approach":"Analysed as time to the first occurrence of one of the listed components (time-to-event composite endpoint)."}
Secondary endpoints
- {"endpoint_text":"- Each of the components of the primary outcome (each analysed as time to first event): recurrent ischemic stroke, haemor-rhagic stroke, unclassified stroke, cardiovascular death, hospitalization due to worsening of heart failure, and hospitalization due to ACS","definition_or_measurement_approach":"Each component analysed as time to first event (time-to-event)."}
- {"endpoint_text":"- Recurrent disabling stroke (as time to first event)","definition_or_measurement_approach":"Analysed as time to first event."}
- {"endpoint_text":"- Recurrent AF (as time to first event)","definition_or_measurement_approach":"Analysed as time to first event."}
- {"endpoint_text":"- Cardiac rhythm (sinus rhythm vs. AF) at 12 and 24 months","definition_or_measurement_approach":"Assessment of cardiac rhythm status at 12 and 24 months (categorical: sinus rhythm vs AF)."}
- {"endpoint_text":"- Unplanned cardiovascular hospitalization (as time to first hospitalization)","definition_or_measurement_approach":"Analysed as time to first unplanned cardiovascular hospitalization."}
- {"endpoint_text":"- Number of cardiovascular hospitalizations","definition_or_measurement_approach":"Count of cardiovascular hospitalizations during follow-up."}
- {"endpoint_text":"- Change from baseline in left ventricular function (left ventricular ejection fraction [LVEF]) at 24 months","definition_or_measurement_approach":"Change from baseline in LVEF measured at 24 months."}
- {"endpoint_text":"- Functional status assessed with the modified Rankin Scale (mRS) at 12 and 24 months","definition_or_measurement_approach":"mRS scores assessed at 12 and 24 months."}
- {"endpoint_text":"- Quality of life assessed with the EuroQol five-dimensional questionnaire (EQ-5D) and Patient-Reported Outcomes Measurement Information System-10 (PROMIS-10) domains on physical and mental health at 12 and 24 months","definition_or_measurement_approach":"EQ-5D and PROMIS-10 domain scores collected at 12 and 24 months."}
- {"endpoint_text":"- Cognitive function assessed with the Montreal Cognitive Assessment (MoCA) at 12 and 24 months","definition_or_measurement_approach":"MoCA scores assessed at 12 and 24 months."}
- {"endpoint_text":"- Cost of therapy","definition_or_measurement_approach":"Health economic evaluation assessing therapy costs."}
Recruitment
- Planned Sample Size
- 711
- Recruitment Window Months
- 64
- Consent Approach
- Written informed consent required from participants. Subject information and informed consent forms provided, including versions for patients and for legal representatives and subsequent consent. ICFs and patient information are available in country/language-specific versions (documents in DE, NL, ES).
Methods
- Recruitment at participating hospitals/Stroke Units across Germany (see K1_DE_Recruitment Arrangements and K2_DE_Recruitment Material_Patient Flyer documents).
- Recruitment at participating hospitals/Neurology centres in the Netherlands (documents: K1_NL_Recruitment Arrangements; K2_Recruitment material_Patientflyer_NL).
- Recruitment at participating hospitals/Stroke Units in Spain (documents: K1_ES_Recruitment Arrangements; K2_ES_Recruitment Material_Patient Flyer).
Geography
- Total Number Of Sites
- 39
- Total Number Of Participants
- 1035
Germany
- Earliest CTIS Part Ii Submission Date
- 13-08-2025
- Latest Decision Or Authorization Date
- 15-04-2026
- Processing Time Days
- 245
- Number Of Sites
- 27
- Number Of Participants
- 495
Sites
- Site Name
- FEK Friedrich-Ebert-Krankenhaus Neumuenster GmbH
- Department Name
- Clinics for Neurology and Rhythmology
- Principal Investigator Name
- Julian Bösel
- Principal Investigator Email
- julian.boesel@fek.de
- Contact Person Name
- Julian Bösel
- Contact Person Email
- julian.boesel@fek.de
- Site Name
- Goethe University Frankfurt
- Department Name
- Zentrum der Neurologie, Neurochirurgie und Neuroradiologie Klinik für Neurologie
- Principal Investigator Name
- Jan Hendrik Schäfer
- Principal Investigator Email
- JanHendrik.Schaefer@unimedizin-ffm.de
- Contact Person Name
- Jan Hendrik Schäfer
- Contact Person Email
- JanHendrik.Schaefer@unimedizin-ffm.de
- Site Name
- Klinikum Frankfurt Hoechst GmbH
- Department Name
- Klinik für Neurologie
- Principal Investigator Name
- Thorsten Steiner
- Principal Investigator Email
- thorsten.steiner@varisano.de
- Contact Person Name
- Thorsten Steiner
- Contact Person Email
- thorsten.steiner@varisano.de
- Site Name
- Justus-Liebig-Universitaet Giessen
- Department Name
- Clinic for Neurology
- Principal Investigator Name
- Martin Jünemann
- Principal Investigator Email
- Martin.Juenemann@neuro.med.uni-giessen.de
- Contact Person Name
- Martin Jünemann
- Contact Person Email
- Martin.Juenemann@neuro.med.uni-giessen.de
- Site Name
- Heidelberg University
- Department Name
- Neurology Clinic
- Principal Investigator Name
- Angelika Alonso
- Principal Investigator Email
- Angelika.Alonso@umm.de
- Contact Person Name
- Angelika Alonso
- Contact Person Email
- Angelika.Alonso@umm.de
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Klinik für Neurologie und klinische Neuropsychologie
- Principal Investigator Name
- Ramona Schuppner
- Principal Investigator Email
- schuppner.ramona@mh-hannover.de
- Contact Person Name
- Ramona Schuppner
- Contact Person Email
- schuppner.ramona@mh-hannover.de
- Site Name
- Universitaetsklinikum Bonn AöR
- Department Name
- Clinic for Vascular Neurology
- Principal Investigator Name
- Gabor Petzold
- Principal Investigator Email
- gabor.petzold@ukbonn.de
- Contact Person Name
- Gabor Petzold
- Contact Person Email
- gabor.petzold@ukbonn.de
- Site Name
- Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
- Department Name
- Clinic and Polyclinic for Neurology
- Principal Investigator Name
- Silke Wunderlich
- Principal Investigator Email
- silke.wunderlich@tum.de
- Contact Person Name
- Silke Wunderlich
- Contact Person Email
- silke.wunderlich@tum.de
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- Vascular neurology
- Principal Investigator Name
- Peter Arthur Ringleb
- Principal Investigator Email
- Peter.Arthur.Ringleb@med.uni-heidelberg.de
- Contact Person Name
- Peter Arthur Ringleb
- Contact Person Email
- Peter.Arthur.Ringleb@med.uni-heidelberg.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR (Luebeck)
- Department Name
- Clinic for Neurology
- Principal Investigator Name
- Georg Royl
- Principal Investigator Email
- Georg.Royl@uksh.de
- Contact Person Name
- Georg Royl
- Contact Person Email
- Georg.Royl@uksh.de
- Site Name
- Staedtisches Klinikum Lueneburg gGmbH
- Department Name
- Clinic for Neurology
- Principal Investigator Name
- Waltraud Pfeilschifter
- Principal Investigator Email
- Waltraud.Pfeilschifter@klinikum-lueneburg.de
- Contact Person Name
- Waltraud Pfeilschifter
- Contact Person Email
- Waltraud.Pfeilschifter@klinikum-lueneburg.de
- Site Name
- Philipps-Universitaet Marburg
- Department Name
- Clinic for Neurology
- Principal Investigator Name
- Anja Gerstner
- Principal Investigator Email
- gerstner@med.uni-marburg.de
- Contact Person Name
- Anja Gerstner
- Contact Person Email
- gerstner@med.uni-marburg.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Clinic for Neurology
- Principal Investigator Name
- Martin Köhrmann
- Principal Investigator Email
- Martin.Koehrmann@uk-essen.de
- Contact Person Name
- Martin Köhrmann
- Contact Person Email
- Martin.Koehrmann@uk-essen.de
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Neurologie mit Schwerpunkt neurovaskuläre Erkrankungen
- Principal Investigator Name
- Annerose Mengel
- Principal Investigator Email
- annerose.mengel@med.uni-tuebingen.de
- Contact Person Name
- Annerose Mengel
- Contact Person Email
- annerose.mengel@med.uni-tuebingen.de
- Site Name
- LMU Klinikum Muenchen AöR
- Department Name
- Institute for Stroke and Dementia Research
- Principal Investigator Name
- Martin Dichgans
- Principal Investigator Email
- Martin.Dichgans@med.uni-muenchen.de
- Contact Person Name
- Martin Dichgans
- Contact Person Email
- Martin.Dichgans@med.uni-muenchen.de
- Site Name
- Rhoen-Klinikum AG
- Department Name
- Klinik für Akutneurologie/Stroke Unit und Intensivmedizin
- Principal Investigator Name
- Hassan Soda
- Principal Investigator Email
- hassan.soda@campus-nes.de
- Contact Person Name
- Hassan Soda
- Contact Person Email
- hassan.soda@campus-nes.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR (Kiel)
- Department Name
- Clinic for Neurology
- Principal Investigator Name
- Milani Deb-Chatterji
- Principal Investigator Email
- Milani.Deb-Chatterji@uksh.de
- Contact Person Name
- Milani Deb-Chatterji
- Contact Person Email
- Milani.Deb-Chatterji@uksh.de
- Site Name
- Vivantes Netzwerk fuer Gesundheit GmbH
- Department Name
- Neurology with Stroke Unit
- Principal Investigator Name
- Darius Nabavi
- Principal Investigator Email
- Darius.Nabavi@vivantes.de
- Contact Person Name
- Darius Nabavi
- Contact Person Email
- Darius.Nabavi@vivantes.de
- Site Name
- Universitaetsklinikum Erlangen AöR
- Department Name
- Neurology Clinic
- Principal Investigator Name
- Stefan Gerner
- Principal Investigator Email
- Stefan.Gerner@uk-erlangen.de
- Contact Person Name
- Stefan Gerner
- Contact Person Email
- Stefan.Gerner@uk-erlangen.de
- Site Name
- Universitaet Muenster
- Department Name
- Clinic for Neurology
- Principal Investigator Name
- Antje Schmidt-Pogoda
- Principal Investigator Email
- antje.schmidt-pogoda@ukmuenster.de
- Contact Person Name
- Antje Schmidt-Pogoda
- Contact Person Email
- antje.schmidt-pogoda@ukmuenster.de
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- Clinic for Neurology
- Principal Investigator Name
- Karl Georg Häusler
- Principal Investigator Email
- georg.haeusler@uniklinik-ulm.de
- Contact Person Name
- Karl Georg Häusler
- Contact Person Email
- georg.haeusler@uniklinik-ulm.de
- Site Name
- Technische Universitaet Dresden
- Department Name
- Klinik und Poliklinik für Neurologie
- Principal Investigator Name
- Timo Siepmann
- Principal Investigator Email
- Timo.Siepmann@ukdd.de
- Contact Person Name
- Timo Siepmann
- Contact Person Email
- Timo.Siepmann@ukdd.de
- Site Name
- Universitaet Leipzig
- Department Name
- Clinic and Polyclinic for Neurology
- Principal Investigator Name
- Dominik Michalski
- Principal Investigator Email
- Dominik.Michalski@medizin.uni-leipzig.de
- Contact Person Name
- Dominik Michalski
- Contact Person Email
- Dominik.Michalski@medizin.uni-leipzig.de
- Site Name
- Evangelisches Klinikum Bethel gGmbH
- Department Name
- Clinic for Neurology
- Principal Investigator Name
- Wolf-Rüdiger Schäbitz
- Principal Investigator Email
- Wolf.Schaebitz@evkb.de
- Contact Person Name
- Wolf-Rüdiger Schäbitz
- Contact Person Email
- Wolf.Schaebitz@evkb.de
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- Department of Neurology
- Principal Investigator Name
- Götz Thomalla
- Principal Investigator Email
- thomalla@uke.de
- Contact Person Name
- Götz Thomalla
- Contact Person Email
- thomalla@uke.de
- Site Name
- University Hospital Cologne AöR
- Department Name
- Clinic for Neurology
- Principal Investigator Name
- Henning Stetefeld
- Principal Investigator Email
- henning.stetefeld@uk-koeln.de
- Contact Person Name
- Henning Stetefeld
- Contact Person Email
- henning.stetefeld@uk-koeln.de
Netherlands
- Earliest CTIS Part Ii Submission Date
- 25-08-2025
- Latest Decision Or Authorization Date
- 30-04-2026
- Processing Time Days
- 248
- Number Of Sites
- 4
- Number Of Participants
- 270
Sites
- Site Name
- Haga Hospital
- Department Name
- Neurology
- Principal Investigator Name
- Jurgen Piet
- Principal Investigator Email
- j.piet@hagaziekenhuis.nl
- Contact Person Name
- Jurgen Piet
- Contact Person Email
- j.piet@hagaziekenhuis.nl
- Site Name
- Amsterdam UMC Stichting
- Department Name
- Neurology
- Principal Investigator Name
- Jonathan Coutinho
- Principal Investigator Email
- j.coutinho@amsterdamumc.nl
- Contact Person Name
- Jonathan Coutinho
- Contact Person Email
- j.coutinho@amsterdamumc.nl
- Site Name
- Radboud universitair medisch centrum Stichting
- Department Name
- Neurology
- Principal Investigator Name
- Anil Taludhar
- Principal Investigator Email
- anil.taludhar@radboudumc.nl
- Contact Person Name
- Anil Taludhar
- Contact Person Email
- anil.taludhar@radboudumc.nl
- Site Name
- Universitair Medisch Centrum Utrecht
- Department Name
- Neurology
- Principal Investigator Name
- Bart van der Worp
- Principal Investigator Email
- h.b.vanderworp@umcutrecht.nl
- Contact Person Name
- Bart van der Worp
- Contact Person Email
- h.b.vanderworp@umcutrecht.nl
Spain
- Earliest CTIS Part Ii Submission Date
- 20-08-2025
- Latest Decision Or Authorization Date
- 20-04-2026
- Processing Time Days
- 243
- Number Of Sites
- 8
- Number Of Participants
- 270
Sites
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Stroke Unit
- Principal Investigator Name
- Angel Ruiz
- Principal Investigator Email
- angel.ruizmo@salud.madrid.org
- Contact Person Name
- Angel Ruiz
- Contact Person Email
- angel.ruizmo@salud.madrid.org
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Stroke Unit
- Principal Investigator Name
- Carlos Molina
- Principal Investigator Email
- carlosav.molina@vallhebron.cat
- Contact Person Name
- Carlos Molina
- Contact Person Email
- carlosav.molina@vallhebron.cat
- Site Name
- Hospital Clinico Universitario De Valladolid
- Department Name
- Stroke Unit
- Principal Investigator Name
- Mercedes De Lera
- Principal Investigator Email
- mlera@saludcastillayleon.es
- Contact Person Name
- Mercedes De Lera
- Contact Person Email
- mlera@saludcastillayleon.es
- Site Name
- Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Department Name
- Stroke Unit
- Principal Investigator Name
- Luis Prats
- Principal Investigator Email
- lpratss@santpau.cat
- Contact Person Name
- Luis Prats
- Contact Person Email
- lpratss@santpau.cat
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- Stroke Unit
- Principal Investigator Name
- Jesus Juega
- Principal Investigator Email
- jjuegam.germanstrias@gencat.cat
- Contact Person Name
- Jesus Juega
- Contact Person Email
- jjuegam.germanstrias@gencat.cat
- Site Name
- Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Department Name
- Stroke Unit
- Principal Investigator Name
- Laura Llull Estrany
- Principal Investigator Email
- blllull@clinic.cat
- Contact Person Name
- Laura Llull Estrany
- Contact Person Email
- blllull@clinic.cat
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Stroke Unit
- Principal Investigator Name
- Alejandro Ponz
- Principal Investigator Email
- ponz_ale@gva.es
- Contact Person Name
- Alejandro Ponz
- Contact Person Email
- ponz_ale@gva.es
- Site Name
- Hospital Universitario Miguel Servet
- Department Name
- Stroke Unit
- Principal Investigator Name
- Cristina Perez Lazaro
- Principal Investigator Email
- cristinaprz785@gmail.com
- Contact Person Name
- Cristina Perez Lazaro
- Contact Person Email
- cristinaprz785@gmail.com
Sponsor
Primary sponsor
- Full Name
- University Medical Center Hamburg-Eppendorf
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Germany
Third parties
- {"country":"Spain","full_name":"Hospital Universitari Vall D Hebron","duties_or_roles":"sponsorDuties codes: 1,12,13,15 (15: National Country Coordinator)","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Germany","full_name":"University Medical Center Hamburg-Eppendorf","duties_or_roles":"sponsorDuties codes: 15 (ECG Core Lab and Ablation Committee)","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Germany","full_name":"University Medical Center Hamburg-Eppendorf","duties_or_roles":"sponsorDuties codes: 13,15 (15: Cardiology)","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Netherlands","full_name":"Universitair Medisch Centrum Utrecht","duties_or_roles":"sponsorDuties codes: 1,12,13,15 (15: National Country Coordinator)","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Netherlands","full_name":"Universitair Medisch Centrum Utrecht","duties_or_roles":"sponsorDuties codes: 1,12,13,15 (15: National Country Coordinator)","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Germany","full_name":"University Medical Center Hamburg-Eppendorf","duties_or_roles":"sponsorDuties codes: 10,6","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Germany","full_name":"University Medical Center Hamburg-Eppendorf","duties_or_roles":"sponsorDuties codes: 13,15 (15: Central trial coordination)","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Germany","full_name":"GKM Gesellschaft fuer Therapieforschung mbH","duties_or_roles":"sponsorDuties codes: 1,12,15 (15: Pharmacovigilance), 5,8","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- DRONEDARONE HYDROCHLORIDE
- Active Substance
- DRONEDARONE HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Authorised (prodAuthStatus 2)
- Maximum Dose
- 800 mg
- Investigational Product Name
- PROPAFENONE HYDROCHLORIDE
- Active Substance
- PROPAFENONE HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Authorised (prodAuthStatus 2)
- Maximum Dose
- 600 mg
- Investigational Product Name
- AMIODARONE HYDROCHLORIDE
- Active Substance
- AMIODARONE HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Authorised (prodAuthStatus 2)
- Maximum Dose
- 600 mg
- Investigational Product Name
- FLECAINIDE ACETATE
- Active Substance
- FLECAINIDE ACETATE
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Authorised (prodAuthStatus 2)
- Maximum Dose
- 300 mg
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