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

  • Germany
      • Berlin, Germany
        • Charité - Universitätsmedizin Berlin

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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Center for Stroke Research Berlin

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.

General Publications

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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