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

NCT03828162 | Completed

• 1 other identifier: OAC and elderly
• Study Type: observational
• Target: 2,943
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Acute coronary syndrome

  2011-11-01 to 2018-12-31

Other Outcomes (1)

• Heart failure

  2011-11-01 to 2018-12-31

Interventions

Anticoagulants DRUG

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Prospective cardiovascular cohort

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Karolinska Institutet: lead

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Anticoagulants

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Bruna Gigante, MD PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: February 4, 2019
• Study Start: November 1, 2010
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2018
• Last Updated: February 4, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: from January 2020