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

Atrial Fibrillation Clinical Trial

— Carebbean-e  

Official title:

Analysis of the Risk and Benefits of Anti-coagulation in Elderly Patients (>=75 Years)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03828162
• Other study ID #: OAC and elderly
• Status: Completed
• Start date: November 1, 2010
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2019
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2943
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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).

Related Conditions & MeSH terms

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

Intervention

Drug:
• Anticoagulants

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Heart failure	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.	2011-11-01 to 2018-12-31
Primary	Ischemic stroke and peripheral embolism	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.	2011-11-01 to 2018-12-31
Primary	Bleeding requiring hospitalization	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.	2011-11-01 to 2018-12-31
Primary	Cardiovascular death	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.	2011-11-01 to 2018-12-31
Secondary	Acute coronary syndrome	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.	2011-11-01 to 2018-12-31