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StrokeFibStrokeNCT02146040

Atrial Fibrillation as a Cause of Stroke and Intracranial Hemorrhage Study (The FibStroke Study)

An observational study of Stroke and Transient Ischemic Attacks, run by University of Turku at 4 sites in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to evaluate the role of atrial fibrillation (AF) and its treatment in relation to thromboembolic events (stroke, and transient ischemic attacks) and intracranial hemorrhage. Read more about this study

Who is it for?
Ages 18 years and older
How many people
5,885 participants
Where
4 sitesFinland
Study dates
Oct 2013to 30 May 2022
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: All patients aged 18 or over, hospitalized or having emergency unit visit during the study period because of thromboembolic event (stroke, TIA) or intracranial hemorrhage and having the diagnosis of atrial fibrillation.

Who may be able to join

  • All patients aged 18 or over, hospitalized or having emergency unit visit during the study period because of thromboembolic event (stroke, TIA) or intracranial hemorrhage and having the diagnosis of atrial fibrillation.

Who cannot join

  • -

Trial locations and contacts

4 sites in 1 country.

Finland4 sites

  • Keski-Suomi Central Hospital

    Jyväskylä

  • Kuopio University Hospital

    Kuopio

  • Satakunta Central Hospital

    Pori

  • Turku University Hospital

    Turku, 20521

Other trials in Finland

About this study

Official title: Incidence and Clinical Predictors of Stroke and Intracranial Hemorrhage in Patients With Atrial Fibrillation. A Retrospective Multicenter Study

The aim of this study is to evaluate the role of atrial fibrillation (AF) and its treatment in relation to thromboembolic events (stroke, and transient ischemic attacks) and intracranial hemorrhage.

Primary Outcome Measures:

Read more
  • Incidence and timing of intracranial complications (stroke,TIA, bleedings) in relation to diagnosis and anticoagulation treatment of AF during the study period; comparison of complications between those with and without anticoagulation treatment according to CHADSVASc score.

Secondary Outcome Measures:

  • The effect of anticoagulation pauses and INR level on stroke and bleeding risk; strokes within 30 days after anticoagulation pause and the prevalence of stroke and intracranila bleeding in relation to INR level < 2, 2-3 and >3.
  • Trauma as a risk factor for intracranial bleeding: percentage and risk factors for intracranial bleeding with or without trauma. Type of preceding trauma and type of intracranial bleeding.
  • The time relation between diagnosis of AF and type of intracranial complications: Kaplan Meier analysis of thrombotic (Stroke/TIA) and intracranial bleeding complications after 1st diagnosis of AF in patients with and without anticoagulation
  • The risk of stroke and intracranial bleeding in relation to CHADSVASc score, HAS-BLED score and anticoagulation/antithrombotic treatment
  • Prognosis of stroke and intracranial bleeding: 30-day mortality after stroke and intracerebral bleeding in patients with and without anticoagulation
  • Factors related to underuse of anticoagulation treatment. Data on reasons for not starting or stopping aticoagulation in those with indication of oral anticoagulation
  • Operations and procedure as risk factor for stroke: Frequency and type of operations performed < 30 days before stroke. Data on length of perioperative pause in anticoagulation and use of bridging therapy and timiing of stroke are collected.
  • Cardioversions as a risk factor for stroke: Frequency of stroke and TIA < 30 days after cardioversion in relation to use of anticoagulation and CHADSVASc score
  • The risk of stroke and intracranial bleeding in relation to type of AF (permanent, persistent, paroxysmal) and concomitant carotid disease

Estimated Enrollment: 6000 patients.

Read the detailed description

Approximately 20% of stroke is caused by atrial fibrillation (AF) and 1% of patients with AF suffer from intracranial hemorrhage. Thus, the net benefit of AF management is the key factor in choosing the successful treatment (pharmacological and interventional).

In this retrospective Finnish multicenter study the investigators collect data on patients with intracranial thromboembolic events or intracranial hemorrhage and AF during the study period. All such patients ≥18 years of age are identified and relevant clinical details are retrospectively gathered from the hospital records of the participating hospitals into an internet-based CRF. The total study period is from 2003 to 2012.

All case records are reviewed using standardized data collection protocol to get information on baseline characteristics and medication of the patients, management of the patients before and during the index complication and during a 30-day follow-up after each complication.

Diagnosis of atrial fibrillation is based 12-lead electrocardiography according to the standard criteria.

Stroke is documented clinically and confirmed by computerized tomography or magnetic resonance imaging to be caused by cerebral infarction. Diagnosis of transient ischemic attacks are based on clinical diagnosis by neurologist when stroke is not confirmed by imaging. After completion of manual registration of data, a computer-based cross-checking of strokes is performed from discharge register data of the included patients to ensure the complete coverage of all events. Diagnosis of inctracranial bleedings are based on patient record and classified as subdural, subarachnoidal and intracerebral and possible preceding trauma is registered. Outcome measures are classified by study neurologist when necessary.

Antigoagulation treatment, INR levels during the index complication, possible pauses in treatment and their casues are registered togethr with information on antiplatelet treatments.

Keywords
anticoagulation, atrial fibrillation, cardioversion, complications, hemorrhage, medications, thromboembolism, TIA, stroke, treatment
Medical subject headings
Stroke, Ischemic Attack, Transient, Intracranial Hemorrhages, Atrial Fibrillation, Hemorrhage, Thromboembolism

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of intracranial complications in relation to diagnosis and anticoagulation treatment of AF during the study period.

    Measured: up to 9 years

Secondary outcomes (1)

  1. The number and the timing of TIAs and strokes in relation to anticoagulation pauses.

    Measured: up to 9 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2014 (estimated)
  2. Study startOct 2013
  3. Primary completionMay 2022
  4. Study completion30 May 2022

Resources

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
Retrospective
Enrolment
5,885 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02146040
Sponsor's protocol ID
T137/2012
Acronym
FibStroke
Status last verified
May 2023
First submitted
7 May 2014
Last updated
23 May 2023
Results posted
No
Data monitoring committee
No

Publications

  • Lehtola H, Palomaki A, Mustonen P, Hartikainen P, Kiviniemi T, Sallinen H, Nuotio I, Ylitalo A, Airaksinen KEJ, Hartikainen J. Traumatic and spontaneous intracranial hemorrhage in atrial fibrillation patients on warfarin. Neurol Clin Pract. 2018 Aug;8(4):311-317. doi: 10.1212/CPJ.0000000000000491.

    PubMed 30140582

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke and Transient Ischemic Attacks, run by University of Turku at 4 sites in Finland.

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 1 inclusion and 1 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 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Finland. 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?

Incidence of intracranial complications in relation to diagnosis and anticoagulation treatment of AF during the study period. (time frame: up to 9 years). 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 NCT02146040, which also lists 1 linked publication.

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 23 May 2023.

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