Atrial Fibrillation: Risk and Benefits of Anti-coagulation in the Elderly

Completed

• Conditions: Frail Elderly Syndrome; Anticoagulants Causing Adverse Effects in Therapeutic Use; Atrial Fibrillation

• Registration Number: NCT03828162
• Lead Sponsor: Karolinska Institutet

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2010-11-01
• Primary Completion: 2017-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-01
• Study First Submitted: 2019-01-30
• Study First Submitted QC: 2019-01-31
• Last Update Submitted: 2019-01-31
• Study First Posted: 2019-02-04
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2943

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.

Read 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).

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bleeding requiring hospitalization	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.
Ischemic stroke and peripheral embolism	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.
Cardiovascular death	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 Outcome Measures

Name	Time	Method
Acute coronary syndrome	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.