NCT02306824

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,080

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

2.9 years

First QC Date

November 30, 2014

Last Update Submit

November 10, 2020

Conditions

Acute Ischemic StrokeAtrial Fibrillation

Outcome Measures

Primary Outcomes (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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with known atrial fibrillation and acute ischemic stroke or transient ischemic attack

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, Germany

Location

Related Publications (2)

  • 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.

    PMID: 39299734DERIVED

  • 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.

    PMID: 34718884DERIVED

MeSH Terms

Conditions

Ischemic StrokeAtrial Fibrillation

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesArrhythmias, CardiacHeart DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Karl Georg Haeusler, MD, FESC

    Wuerzburg University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

November 30, 2014

First Posted

December 3, 2014

Study Start

December 1, 2014

Primary Completion

November 1, 2017

Study Completion

November 1, 2020

Last Updated

November 13, 2020

Record last verified: 2020-11

Locations

DE(1)