Acute Ischemic StrokeNCT02306824
Berlin Atrial Fibrillation Registry
An observational study of Acute Ischemic Stroke and Atrial Fibrillation, run by Charite University, Berlin, Germany at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke, Atrial Fibrillation
- How many people
- 1,080 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2014to Nov 2020
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with known atrial fibrillation and acute ischemic stroke or transient ischemic attack
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Acute Ischemic Stroke, Atrial Fibrillation
- Medical subject headings
- Ischemic Stroke, Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionNov 2017
- Study completionNov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,080 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Stroke Research Berlin, Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
- Responsible party
- Principal investigator, Karl Georg Haeusler, Charite University, Berlin, Germany
- Investigators
- Karl Georg Haeusler, MD, FESC, Principal investigator, Wuerzburg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02306824
- Sponsor's protocol ID
- EA2/052/14
- Status last verified
- Nov 2020
- First submitted
- 30 Nov 2014
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 39299734Tutuncu 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.
PubMed 34718884
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Berlin Cohort Study on Oral Anticoagulation in Patients With Atrial Fibrillation and Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT02306824
- Acronym / sponsor ID
- EA2/052/14
- Conditions
- Acute Ischemic Stroke, Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,080 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Center for Stroke Research Berlin, Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
- Study start
- Dec 2014
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2020 (actual)
- First posted
- 3 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with known atrial fibrillation and acute ischemic stroke or transient ischemic attack
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Derived from this study: PubMed 39299734Olma 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.
- Derived from this study: PubMed 34718884Tutuncu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl Georg Haeusler, MD, FESC principal investigator
Wuerzburg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke and Atrial Fibrillation, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02306824, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.