- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02306824
Berlin Atrial Fibrillation Registry
November 10, 2020 updated by: Karl Georg Haeusler, Charite University, Berlin, Germany
Berlin Cohort Study on Oral Anticoagulation in Patients With Atrial Fibrillation and Acute Ischemic Stroke
Investigator-initiated prospective multicentre hospital-based registry to uncover the proportion of self-reported anticoagulation in stroke patients with atrial fibrillation and assessing the proportion of stroke, intracranial bleeding and all-cause death in the short (at 3 months), mid-term (at 12 months) as well as long term (at 24 months) after ischemic stroke or transient ischemic attack in an unselected urban population in Germany.
In addition, annual follow-up is planned yearly up to 5 years after enrollment.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
1080
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Berlin, Germany
- Charité - Universitätsmedizin Berlin
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with known atrial fibrillation and acute ischemic stroke or transient ischemic attack
Description
Inclusion Criteria:
- Acute ischemic stroke or transient ischemic attack (with clinical deficit on admission or corresponding brain MRI lesion)
- Age ≥ 18 years
- Known atrial fibrillation or ECG recording documenting atrial fibrillation during the in-hospital stay for acute ischemic stroke or transient ischemic attack
- Written or oral informed consent
- Willingness to take part in the planned follow up examinations
Exclusion Criteria:
- Life expectancy < 1 year (before stroke)
- Assumed post-stroke life expectancy < 1 month according to stroke severity
- Chronic anticoagulation for reasons other than atrial fibrillation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patient self-reported persistence to oral anticoagulants (novel oral anticoagulants or vitamin K antagonists) in stroke patients with AF at 12 months after ischemic stroke or TIA
Time Frame: 12 months
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12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Karl Georg Haeusler, MD, FESC, Wuerzburg University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2014
Primary Completion (Actual)
November 1, 2017
Study Completion (Actual)
November 1, 2020
Study Registration Dates
First Submitted
November 30, 2014
First Submitted That Met QC Criteria
December 2, 2014
First Posted (Estimate)
December 3, 2014
Study Record Updates
Last Update Posted (Actual)
November 13, 2020
Last Update Submitted That Met QC Criteria
November 10, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EA2/052/14
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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Ablacon, Inc.RecruitingAtrial Fibrillation | Arrhythmias, Cardiac | Arrhythmia | Atrial Flutter | Atrial Fibrillation, Persistent | Atrial Tachycardia | Atrial Arrhythmia | Atrial Fibrillation Paroxysmal | Atrial Fibrillation, Paroxysmal or PersistentUnited States, Belgium, Netherlands, Czechia
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Maastricht University Medical CenterRWTH Aachen UniversityUnknownAtrial Fibrillation (Paroxysmal) | Atrial Fibrillation Recurrent | Atrial Fibrillation Common Gene VariantsNetherlands
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R-PharmFSBI "National Medical Research Center of Cardiology named after academician...CompletedAtrial Flutter | Paroxysmal Atrial Fibrillation | Persistent Atrial FibrillationRussian Federation