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临床试验/NCT03828162
NCT03828162已完成不适用

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

Karolinska Institutet0 个研究点目标入组 2,943 人开始时间: 2010年11月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
2,943
主要终点
Bleeding requiring hospitalization

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
75 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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).

结局指标

主要结局

Bleeding requiring hospitalization

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • Acute coronary syndrome(2011-11-01 to 2018-12-31)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bruna Gigante

Associate professor

Karolinska Institutet

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