Berlin Atrial Fibrillation Registry

NCT ID: NCT02306824

Last Updated: 2020-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1080 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2020-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Ischemic Stroke Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Center for Stroke Research Berlin

OTHER

Sponsor Role collaborator

Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

INDUSTRY

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Karl Georg Haeusler

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karl Georg Haeusler, MD, FESC

Role: PRINCIPAL_INVESTIGATOR

Wuerzburg University Hospital

Locations

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Charité - Universitätsmedizin Berlin

Berlin, , Germany

Site Status

Countries

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Germany

References

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Olma MC, Tutuncu S, Hansen K, Grittner U, Kunze C, Dietzel J, Schurig J, Dimitrijeski B, Hagemann G, Hamilton F, Honermann M, Jungehuelsing GJ, Kauert A, Koennecke HC, Mackert BM, Nabavi DG, Schmehl I, Sparenberg P, Stingele R, Voelzke E, Waldschmidt C, Zeise-Wehry D, Heuschmann PU, Endres M, Haeusler KG. Timing of oral anticoagulation in atrial fibrillation patients after acute ischaemic stroke and outcome after 3 months: results of the multicentre Berlin Atrial Fibrillation Registry. Open Heart. 2024 Sep 18;11(2):e002688. doi: 10.1136/openhrt-2024-002688.

Reference Type DERIVED
PMID: 39299734 (View on PubMed)

Tutuncu S, Olma M, Kunze C, Dietzel J, Schurig J, Fiessler C, Malsch C, Haas TE, Dimitrijeski B, Doehner W, Hagemann G, Hamilton F, Honermann M, Jungehulsing GJ, Kauert A, Koennecke HC, Mackert BM, Nabavi D, Nolte CH, Reis JM, Schmehl I, Sparenberg P, Stingele R, Volzke E, Waldschmidt C, Zeise-Wehry D, Heuschmann PU, Endress M, Haeusler KG. Off-label-dosing of non-vitamin K-dependent oral antagonists in AF patients before and after stroke: results of the prospective multicenter Berlin Atrial Fibrillation Registry. J Neurol. 2022 Jan;269(1):470-480. doi: 10.1007/s00415-021-10866-2. Epub 2021 Oct 31.

Reference Type DERIVED
PMID: 34718884 (View on PubMed)

Other Identifiers

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EA2/052/14

Identifier Type: -

Identifier Source: org_study_id