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Berlin Atrial Fibrillation Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02306824
Recruitment Status : Active, not recruiting
First Posted : December 3, 2014
Last Update Posted : August 2, 2019
Sponsor:
Collaborators:
Center for Stroke Research Berlin
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Information provided by (Responsible Party):
Karl Georg Haeusler, Charite University, Berlin, Germany

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
Acute Ischemic Stroke Atrial Fibrillation

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Study Type : Observational [Patient Registry]
Actual Enrollment : 1080 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Berlin Cohort Study on Oral Anticoagulation in Patients With Atrial Fibrillation and Acute Ischemic Stroke
Study Start Date : December 2014
Actual Primary Completion Date : November 2017
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine





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 [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with known atrial fibrillation and acute ischemic stroke or transient ischemic attack
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02306824


Locations
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Germany
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
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Principal Investigator: Karl Georg Haeusler, MD, FESC Wuerzburg University Hospital
Additional Information:

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Responsible Party: Karl Georg Haeusler, Prof., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02306824    
Other Study ID Numbers: EA2/052/14
First Posted: December 3, 2014    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Atrial Fibrillation
Ischemia
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes