NCT Number: NCT03828162
Atrial Fibrillation: Risk and Benefits of Anti-coagulation in the Elderly
This study was designed to assess the effectiveness of oral anticoagulants in elderly patients (>=75 years) with atrial fibrillation. All patients discharged from one large hospital in Stockholm, Danderyds Hospital, between november 1st 2010 and december 31st 2017 with atrial fibrillation as main diagnosis have been included (n=2943). Adverse events (cardiovascular death, fatal/non fatal ischemic stroke, peripheral thromboembolism, fatal/non fatal intracerebral hemorrhage and extracranial bleeding) are recorded through linkage to mandatory and qualitative national registries and review of the medical records until december 31 2018.
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Conditions
Age range
75 year and older
Sex eligibility
All sexes
Study type
Observational
About this study
The investigators established a prospective cohort of 2943 of elderly (>=75 years old) discharged with atrial fibrillation as main diagnosis from November 1st 2010 to December 31st 2017 from a large hospital in the Northern part of Stockholm in Sweden, Danderyds Hospital. Atrial fibrillation diagnosis is defined by the (ICD-10) codes: I48.0-I48.9 (atrial fibrillation and atrial flutter) according to the International Classification of Diseases, 10th revision. The first admission to the hospital during the study period is recorded as the index admission.
Clinical and anamnestic data, anthropometric measures, biochemical data, treatment at admission and at discharge have been recorded for each patient through the screening of medical journals.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- All consecutive patients discharged with atrial fibrillation as main diagnosis from Danderyds Hospital from November 1st 2011 to December 31 2017 aged 75 years or more.
Exclusion criteria
- Patients who have not given their consensus to the use of medical journals for register based research.
- Patients who were discharged from the hospital with atrial fibrillation as main diagnosis but were admitted to the hospital for medical reasons unrelated to atrial fibrillation (as an example change of pacemakers batteries).
- Patients whose medical records are not consistent with the main diagnosis (as an example wrong ICD code).
Treatment and study plan
Primary outcomes
-
Ischemic stroke and peripheral embolism
Time frame: 2011-11-01 to 2018-12-31
Ischemic stroke and peripheral embolism have been defined according to the International Classification of Diseases (ICD-10) by the codes: ICD I63-I66. Data are extracted from the swedish national patients register.
-
Bleeding requiring hospitalization
Time frame: 2011-11-01 to 2018-12-31
Intracranial and extracranial bleeding have been defined according to the International Classification of Diseases (ICD-10) by the codes: ICD I63-I66. I60, I62, K25.0, K25.2, K25.4, K25.6, K29.0, K65, K92, N02, R19.5, R31, M62.2, N95.0, DR029).
Data are extracted from the swedish national patients register.
-
Cardiovascular death
Time frame: 2011-11-01 to 2018-12-31
Cardiovascualr death is defined according to the International Classification of Diseases (ICD-10) by the codes:I00-I99. Data are extracted from the swedish national cause of death register.
Secondary outcomes
-
Acute coronary syndrome
Time frame: 2011-11-01 to 2018-12-31
Acute coronary syndrome have been defined according to the International Classification of Diseases (ICD-10) by the codes: I20-I24.
Data are extracted from the swedish national patients register.
Other outcomes
-
Heart failure
Time frame: 2011-11-01 to 2018-12-31
Heart failure has been defined according to the International Classification of Diseases (ICD-10) by the code: I50.
Data are extracted from the swedish national patients register.
Sponsors and collaborators
Lead sponsor
Karolinska Institutet
Other
Registry information
Official study title
Analysis of the Risk and Benefits of Anti-coagulation in Elderly Patients (>=75 Years)
Acronym: Carebbean-e
Important dates
- Study start
- 2010
- Primary completion
- 2017
- Study completion
- 2018
- First posted
- Feb 4, 2019
- Registry last updated
- Feb 4, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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