Berlin Atrial Fibrillation Registry

Atrial Fibrillation Clinical Trial

Official title:

Berlin Cohort Study on Oral Anticoagulation in Patients With Atrial Fibrillation and Acute Ischemic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02306824
• Other study ID #: EA2/052/14
• Status: Completed
• Start date: December 2014
• Est. completion date: November 2020

Study information

• Verified date: November 2020
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1080
• Est. completion date: November 2020
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Atrial Fibrillation
• Ischemia

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin	Berlin

Sponsors (3)

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

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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