- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04371055
Intensive Rhythm Monitoring to Decrease Ischemic Stroke and Systemic Embolism - the Find-AF 2 Study (Find-AF2)
Intensive Heart Rhythm Monitoring to Decrease Ischemic Stroke and Systemic Embolism - the Find-AF 2 Study
Patients who have suffered a stroke are having an increased risk of having recurrent stroke in the future. This risk of stroke is increased by atrial fibrillation, which often "comes and goes" (called paroxysmal) and hence escapes routine diagnostics. The hypothesis of Find-AF 2 is that enhanced (evaluation in a ECG core lab), prolonged (at least 7 days of rhythm monitoring annually) and intensified (continuous rhythm monitoring in high risk patients) not only finds atrial fibrillation more often, but that changes in therapeutic management (e. g. start of anticoagulation after detection of atrial fibrillation) results in a decrease of cardioembolism (which can be either recurrent stroke or systemic embolism).
To prove this hypothesis, patients will be randomised into two groups: the first group will receive the currently available standard care for patients with stroke. In the second group, cardiac rhythm monitoring adapted to the risk of the occurrence of atrial fibrillation is performed - either with a 7-day long-term ECG (at baseline, after 3 and 12 months and every 12 months thereafter) or with continuous monitoring using an implantable cardiac monitor. If atrial fibrillation is detected, this information will be given to the treating study physician. Any therapeutic decision is at the discretion of the treating physician, but should follow current guidelines.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The Find AF 2 study will investigate whether intensified rhythm monitoring in patients with recent ischemic stroke leads to a decrease in recurrent thromboembolism (defined as recurrent ischemic stroke or systemic embolism). This will be achieved by identifying patients with paroxysmal atrial fibrillation and subsequently switching secondary prevention therapy from antiplatelet therapy to oral anticoagulation. The intensity of heart rhythm monitoring will be risk-adjusted: Patients with an estimated low risk of atrial fibrillation receive a 7-day Holter ECG, which is repeated after 3 and 12 months and annually thereafter. Patients with a high risk of atrial fibrillation (defined by increased supraventricular ectopic activity) receive continuous ECG monitoring using an implanted loop recorder. The control arm is treated according to local standards, which includes cardiac rhythm monitoring for at least 24 hours according to current guidelines. Prior to randomization, a 24-hour Holter ECG is performed in both study arms, ensuring minimal ECG monitoring for patients in the control arm and allowing risk stratification in the intervention arm. Additional ECG monitoring using stroke telemetry and/or additional Holter ECGs is possible according to local standards, provided it does not exceed 7 days. Patients in both study arms will be followed up for at least 24 months.
It should be noted that this study only provides diagnostic information, the therapeutic decision is left to the treating physician.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Katrin Wasser, PD Dr. med.
- Phone Number: +49-551-3920-194
- Email: k.wasser@med.uni-goettingen.de
Study Locations
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Altenburg, Germany
- Recruiting
- Klinikum Altenburger Land
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Contact:
- Jörg Berrouschot, Prof. Dr.
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Aschaffenburg, Germany
- Recruiting
- Klinikum Aschaffenburg-Alzenau
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Contact:
- Oliver Bähr, Prof. Dr.
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Augsburg, Germany
- Recruiting
- Universitätsklinikum Augsburg
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Contact:
- Michael Ertl, PD Dr.
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Bad Neustadt An Der Saale, Germany
- Recruiting
- Rhön Klinikum Campus Bad Neustadt
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Contact:
- Hassan Soda, Dr.
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Bamberg, Germany
- Recruiting
- Sozialstiftung Bamberg; Klinikum am Bruderwald
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Contact:
- Herwig Strik, Prof. Dr.
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Berlin, Germany
- Recruiting
- BG Klinikum, Unfall-KH Berlin gGmbH
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Contact:
- Mirko Seidel, Dr.
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Berlin, Germany
- Recruiting
- Vivantes Klinikum Neukölln Berlin
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Contact:
- Darius G Nabavi, Prof. Dr.
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Berlin, Germany
- Recruiting
- Vivantes, Humboldt-Klinikum Berlin
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Contact:
- Bettina Schmitz, Prof. Dr.
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Berlin-Spandau, Germany
- Recruiting
- Vivantes Klinikum Spandau
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Contact:
- Jörg Müller, Prof. Dr.
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Bielefeld, Germany, 33611
- Recruiting
- Evangelisches Klinikum Bethel, Klinik für Neurologie
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Contact:
- Wolf R Schäbitz, Prof. Dr.
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Bonn, Germany
- Recruiting
- Universitatsklinikum Bonn
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Contact:
- Gabor Petzold, Prof. Dr.
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Bremen, Germany
- Recruiting
- Klinikum Bremen Mitte
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Contact:
- Andreas Kastrup, Prof. Dr.
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Coburg, Germany, 96450
- Recruiting
- Klinikum Coburg, Medizinische Klinik für Innere Medizin und Kardiologie
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Contact:
- Christian Mahnkopf, Dr.
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Darmstadt, Germany
- Recruiting
- Klinikum Darmstadt
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Contact:
- Rainer Kollmar, Prof. Dr.
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Dresden, Germany
- Recruiting
- Städtisches Klinikum Dresden, Standort Friedrichstadt
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Contact:
- Sebastian Schellong, Prof. Dr.
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Dresden, Germany
- Recruiting
- Universitätsklinikum Carl Gustav Carus
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Contact:
- Lars P Pallesen, Dr.
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Erlangen, Germany
- Recruiting
- Universitatsklinikum Erlangen
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Contact:
- Bernd Kallmünzer, PD Dr.
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Essen, Germany, 45147
- Recruiting
- University of Essen, Clinic for Neurology
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Contact:
- Martin Köhrmann, Prof. Dr.
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Frankfurt, Germany
- Recruiting
- Universitatsklinikum Frankfurt
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Contact:
- Natalia Kurka, Dr.
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Frankfurt, Germany
- Recruiting
- Klinikum Frankfurt Höchst
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Contact:
- Thorsten Steiner, Prof. Dr.
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Fulda, Germany
- Recruiting
- Klinikum Fulda
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Contact:
- Tobias Neumann-Haefelin, Prof. Dr.
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Gießen, Germany
- Recruiting
- Universitätsklinikum Giessen und Marburg GmbH
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Contact:
- Martin Jünemann, Dr.
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Contact:
- Hagen Huttner, Prof. Dr.
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Göttingen, Germany, 37075
- Recruiting
- University of Göttingen, Clinic for Neurology
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Contact:
- Jan Liman, Prof. Dr.
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Günzburg, Germany
- Recruiting
- Bezirkskrankenhaus Günzburg
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Contact:
- Gerhard F Hamann, Prof.
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Halle, Germany
- Recruiting
- Krankenhaus Martha-Maria Halle-Dölau
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Contact:
- Frank Hoffmann, Dr.
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Hamburg, Germany
- Recruiting
- Universitätsklinikum Hamburg-Eppendorf
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Contact:
- Götz Thomalla, Prof. Dr.
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Hamburg, Germany
- Recruiting
- Albertinenkrankenhaus Hamburg
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Contact:
- Michael Rosenkranz, PD Dr.
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Hamburg, Germany
- Recruiting
- Asklepios Klinik Altona Hamburg
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Contact:
- Joachim Röther, Prof. Dr.
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Hamburg, Germany
- Recruiting
- Asklepios Klinik Wandsbek, Hamburg
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Contact:
- Lars Marquardt, PD Dr. Dr.
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Hannover, Germany
- Recruiting
- Medizinische Hochschule Hannover
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Contact:
- Karin Weißenborn, Prof. Dr.
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Heidelberg, Germany
- Recruiting
- UniversitatsKlinikum Heidelberg
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Contact:
- Peter A. Ringleb, Prof. Dr.
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Höxter, Germany
- Recruiting
- Klinikum Höxter
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Contact:
- Mark Obermann, Prof. Dr.
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Ibbenbüren, Germany
- Recruiting
- Klinikum Ibbenbüren
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Contact:
- Florian Bethke, Dr.
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Kaiserslautern, Germany
- Withdrawn
- Westpfalz Klinikum GmbH - Standort Kaiserslautern
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Leipzig, Germany
- Terminated
- Klinikum St. Georg Leipzig
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Lüneburg, Germany
- Recruiting
- Städtisches Klinikum Lüneburg gemeinnützige GmbH
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Contact:
- Waltraud Pfeilschifter, Prof. Dr.
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Mainz, Germany, 55131
- Recruiting
- University of Mainz, Clinic for Neurology
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Contact:
- Klaus Gröschel, Prof. Dr.
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Mannheim, Germany
- Withdrawn
- Universitätsklinikum Mannheim
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Merseburg, Germany
- Recruiting
- Carl-von-Basedow Klinikum Merseburg
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Contact:
- Carsten Hobohm, Dr.
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Minden, Germany
- Recruiting
- Klinikum Minden
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Contact:
- Peter Schellinger, Prof. Dr.
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Mühlhausen, Germany
- Recruiting
- Ökumenisches Hainich Klinikum Mühlhausen
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Contact:
- Marek Jauß, Prof. Dr.
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Münster, Germany
- Recruiting
- Universitätsklinikum Münster
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Contact:
- Jens Minnerup, Prof. Dr.
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Osnabrück, Germany
- Recruiting
- Klinikum Osnabrück GmbH
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Contact:
- Lars U Krause, Dr.
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Passau, Germany
- Recruiting
- Klinikum Passau
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Contact:
- Tobias Freilinger, Prof. Dr.
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Sande, Germany, 26452
- Recruiting
- Nordwest-Krankenhaus Sanderbusch, Klinik für Neurologie
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Contact:
- Pawel Kermer, Prof. Dr.
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Siegen, Germany
- Recruiting
- Kreisklinikum Siegen
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Contact:
- Martin Grond, Prof. Dr.
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Traunstein, Germany
- Recruiting
- Kliniken Südostbayern AG, Klinikum Traunstein
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Contact:
- Thorleif Etgen, Prof. Dr.
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Tübingen, Germany
- Recruiting
- Universitatsklinikum Tubingen
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Ulm, Germany
- Recruiting
- Universitatsklinikum Ulm
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Contact:
- Katharina Althaus, Dr.
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Wiesbaden, Germany
- Recruiting
- Helios Dr. Horst Schmidt-Kliniken Wiesbaden
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Contact:
- Frank A Wollenweber, Prof. Dr.
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Würzburg, Germany
- Recruiting
- Universitatsklinikum Wurzburg
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Contact:
- Karl G Häusler, Prof. Dr.
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Bayern
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München, Bayern, Germany
- Recruiting
- ISD München
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Contact:
- Martin Dichgans, Prof. Dr.
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Nürnberg, Bayern, Germany, 90471
- Recruiting
- Klinikum Nürnberg
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Contact:
- Martin Nückel, MD
- Phone Number: +49-911-398-2491
- Email: martin.nueckel@klinikum-nuernberg.de
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Saxony
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Leipzig, Saxony, Germany, 04103
- Recruiting
- University of Leipzig, Clinic for Neurology
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Contact:
- Dominik Michalski, Prof. Dr.
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Contact:
- Rolf Wachter, Prof. Dr.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Recent ischemic stroke (sudden focal neurologic deficit lasting > 24h consistent with the territory of a major cerebral artery) and/or a corresponding lesion on brain imaging within the last 30 days
- Age ≥ 60 years
- Patient without or with only slight disability (modified Rankin Scale score ≤ 2) before onset of stroke-related symptoms.
- Written informed consent
Exclusion Criteria:
- Known history of atrial fibrillation/flutter or atrial fibrillation/flutter on admission ECG
- Current indication or contraindication for oral anticoagulation at randomisation
- Intracerebral bleeding in medical history
- Patient scheduled for ECG-monitoring lasting > 7 days (Holter-ECG, implanted loop recorder, etc.)
- Implanted pacemaker device or cardioverter/ defibrillator
- Patient not willing to be treated with oral anticoagulants
- Carotid artery stenosis ipsilateral to the current ischemic stroke needing operation or intervention.
- History of carotid endarterectomy or percutaneous intervention of cerebral artery within the last 30 days.
- Life expectancy <1 year for reasons other than stroke (e.g. metastatic cancer)
- patients under legal supervision or guardianship
- psychological/mental or other inabilities to supply required information (e.g. fill out the questionnaire due to dementia, language difficulties,...) or participate in the required tests
- participation in other randomised interventional trials
- suspected lack of compliance
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Risk-adapted ECG monitoring for atrial fibrillation
Intervention Group with high Risk for AF: Continuous Rhythm Monitoring using an implantable cardiac Monitor Intervention group with low risk for AF: 7-day Holter ECG at baseline, after 3 and 12 months and then annually until the end of the study or the first occurrence of atrial Fibrillation |
7-day Holter ECG at baseline and after 3 and 12 months and then annually until the end of the study or the first (in patients with low risk of atrial fibrillation)
Continuous rhythm monitoring using an implantable cardiac monitor
|
Other: Standard of Care
Standard of care rhythm monitoring
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Usual care according to current guidelines (in patients with low and high risk of atrial fibrillation)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary efficacy endpoint: Time until recurrent ischemic stroke or systemic embolism
Time Frame: from the date of randomization until the date of first documented ischemic stroke or date of first systemic embolism, whichever comes first, assessed up to 60 months
|
The trial will be event driven.
The minimum follow-up in each patient is 24 months, but may be followed for up to 60 months.
|
from the date of randomization until the date of first documented ischemic stroke or date of first systemic embolism, whichever comes first, assessed up to 60 months
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Primary safety endpoint: Time until the first haemorrhagic stroke
Time Frame: from the date of randomization until the date of first documented haemorrhagic stroke, assessed up to 60 months
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Time until the first haemorrhagic stroke
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from the date of randomization until the date of first documented haemorrhagic stroke, assessed up to 60 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time until the combination of stroke, myocardial infarction and cardiovascular death
Time Frame: from the date of randomization until the date of first documented stroke, the date of myocardial infarction and the date of cardiovascular death, whichever comes first, assessed up to 60 months
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Time until the combination of stroke, myocardial infarction and cardiovascular death
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from the date of randomization until the date of first documented stroke, the date of myocardial infarction and the date of cardiovascular death, whichever comes first, assessed up to 60 months
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Time until any stroke
Time Frame: from the date of randomization until the date of first documented any stroke, assessed up to 60 months
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Time until any stroke
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from the date of randomization until the date of first documented any stroke, assessed up to 60 months
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Time until new onset of AF
Time Frame: from the date of randomization until the date of first documented AF, assessed up to 60 months
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Time until new onset of Atrial Fibrillation
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from the date of randomization until the date of first documented AF, assessed up to 60 months
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Time until all cause mortality
Time Frame: from the date of randomization until the date of all cause mortality assessed up to 60 months
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Time until all cause mortality
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from the date of randomization until the date of all cause mortality assessed up to 60 months
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Time until myocardial infarction
Time Frame: from the date of randomization until the date of all myocardial infarction, assessed up to 60 months
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Time until myocardial infarction
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from the date of randomization until the date of all myocardial infarction, assessed up to 60 months
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Changes in quality of life (QoL), measured by the stroke impact scale (SIS-16)
Time Frame: Mean change from baseline until study end assessed up to 60 months in both study arms
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Changes in quality of life (QoL), measured by the stroke impact scale (SIS-16).
The SIS-16 ranges from 16 to 80, with higher scores showing better Quality of life.
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Mean change from baseline until study end assessed up to 60 months in both study arms
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Changes in the EQ-5D five dimensional Quality of Life (QoL)
Time Frame: Mean change from baseline until study end assessed up to 60 months in both study arms
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Changes in the EQ-5D five dimensional Quality of Life (QoL)
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Mean change from baseline until study end assessed up to 60 months in both study arms
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Changes in the overall QoL visual analog scale
Time Frame: Mean change from baseline until study end assessed up to 60 months in both study arms, ranging from 0 to 100, with higher values indicating better quality of life
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Changes in the overall QoL visual analog scale
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Mean change from baseline until study end assessed up to 60 months in both study arms, ranging from 0 to 100, with higher values indicating better quality of life
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Rolf Wachter, Prof. Dr., University of Leipzig, Clinic and Policlinis for Cardiology
- Principal Investigator: Klaus Gröschel, Prof. Dr., University of Mainz, Clinic and Policlinis for Neurology
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Necrosis
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Embolism and Thrombosis
- Arrhythmias, Cardiac
- Brain Ischemia
- Infarction
- Brain Infarction
- Stroke
- Ischemic Stroke
- Embolism
- Ischemia
- Atrial Fibrillation
- Cerebral Infarction
Other Study ID Numbers
- Find-AF 2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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