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

NCT02146040 | Completed

• 1 other identifier: T137/2012
• Study Type: observational
• Target: 5,885
• Locations: 1 country
• Sites: 4

Brief 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. Primary Outcome Measures: \- 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.

Conditions

Stroke; Transient Ischemic Attacks; Intracranial Hemorrhage; Atrial Fibrillation

Keywords

anticoagulation; atrial fibrillation; cardioversion; complications; hemorrhage; medications; thromboembolism; TIA; stroke; treatment

Outcome Measures

Primary Outcomes (1)

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

  up to 9 years

Secondary Outcomes (1)

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

  up to 9 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Turku: lead

Study Sites (4)

Keski-Suomi Central Hospital

Jyväskylä, Finland

Location

Kuopio University Hospital

Kuopio, Finland

Location

Satakunta Central Hospital

Pori, Finland

Location

Turku University Hospital

Turku, 20521, Finland

Location

Related Publications (1)

• 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.

  PMID: 30140582 DERIVED

MeSH Terms

Conditions

Stroke; Ischemic Attack, Transient; Intracranial Hemorrhages; Atrial Fibrillation; Hemorrhage; Thromboembolism

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac; Heart Diseases; Embolism and Thrombosis

Study Officials

• Juhani Airaksinen, Professor

  Turku University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 7, 2014
• First Posted: May 23, 2014
• Study Start: October 1, 2013
• Primary Completion: May 1, 2022
• Study Completion: May 30, 2022
• Last Updated: May 23, 2023

Record last verified: 2023-05

Locations

FI (4)