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Berlin Atrial Fibrillation Registry

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Completed
CT.gov ID
NCT02306824
Collaborator
Center for Stroke Research Berlin (Other), Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma (Industry)
1,080
Enrollment
1
Location
71
Duration (Months)
15.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    1080 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Berlin Cohort Study on Oral Anticoagulation in Patients With Atrial Fibrillation and Acute Ischemic Stroke
    Study Start Date :
    Dec 1, 2014
    Actual Primary Completion Date :
    Nov 1, 2017
    Actual Study Completion Date :
    Nov 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. 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 [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Charité - Universitätsmedizin Berlin Berlin Germany

    Sponsors and Collaborators

    • Charite University, Berlin, Germany
    • Center for Stroke Research Berlin
    • Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

    Investigators

    • Principal Investigator: Karl Georg Haeusler, MD, FESC, Wuerzburg University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Karl Georg Haeusler, Prof., Charite University, Berlin, Germany
    ClinicalTrials.gov Identifier:
    NCT02306824
    Other Study ID Numbers:
    • EA2/052/14
    First Posted:
    Dec 3, 2014
    Last Update Posted:
    Nov 13, 2020
    Last Verified:
    Nov 1, 2020
    Additional relevant MeSH terms:
    Ischemic Stroke
    Atrial Fibrillation

    Study Results

    No Results Posted as of Nov 13, 2020