Status:
ACTIVE_NOT_RECRUITING
Intensive Rhythm Monitoring to Decrease Ischemic Stroke and Systemic Embolism - the Find-AF 2 Study
Lead Sponsor:
University of Leipzig
Collaborating Sponsors:
Johannes Gutenberg University Mainz
Conditions:
Ischemic Stroke
Atrial Fibrillation
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
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...
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 strok...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2026
Estimated Enrollment :
5227 Patients enrolled
Trial Details
Trial ID
NCT04371055
Start Date
July 7 2020
End Date
December 31 2026
Last Update
June 4 2025
Active Locations (52)
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1
ISD München
München, Bavaria, Germany
2
Klinikum Nürnberg
Nuremberg, Bavaria, Germany, 90471
3
Klinikum Bremen Mitte
Bremen, City state Bremen, Germany
4
University of Leipzig, Clinic for Neurology
Leipzig, Saxony, Germany, 04103