跳至主要内容
临床试验/NCT04080830
NCT04080830Unknown不适用

Patient Registration Study of Acute Ischemic Stroke/Transient Ischemic Attack(TIA ) With Atrial Fibrillation

Xuanwu Hospital, Beijing1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,000
试验地点
1
主要终点
The rate of recurrent Ischemic stroke/TIA and symptomatic systemic embolism

研究概览

简要总结

Patient Registration Study of Acute Ischemic Stroke/transient ischemic attack(TIA) With Atrial Fibrillation (AISWAF) is a single-center prospective, consecutively, observational study, was conducted in patients with acute ischemic stroke/TIA with atrial fibrillation. The aim of this study was to understand the stroke mechanism, the regularity of stroke recurrence and its influencing factors, to establish a risk stratification model for stroke recurrence, and to preliminarily explore the relationship between stroke mechanism, risk stratification and antithrombotic regimen in this population.

详细描述

Patients with acute ischemic stroke (IS) and atrial fibrillation (AF) are at particularly high risk of recurrent IS and other major vascular events. Current antithrombotic therapy guidelines recommend oral anticoagulation (OAC) alone for the secondary prevention of IS in this high-risk population. However, these guidelines are largely based on evidence from randomized-controlled trials that did not include patients with acute IS. With the exception of the European Atrial Fibrillation Trial (EAFT), all randomized-controlled trials evaluating antithrombotic therapy in patients with AF included primary prevention populations. Moreover, the EAFT trial does not inform the management of patients with severe stroke, as these patients were excluded from this trial, and it did not evaluate the safety and efficacy of combination OAC and antiplatelet therapy.Current observational studies also provide very limited information about the optimal antithrombotic regimen for different stroke mechanisms in acute ischemic stroke/transient ischemic attack(TIA) with atrial fibrillation. In fact , the regularity of recurrence, the specific mechanism of ischemic stroke and the optimal antithrombotic regimen for different stroke mechanisms in these patients are still not clear, which limited clinical treatment level of these patients. Patient Registration Study of Acute Ischemic Stroke/transient ischemic attack(TIA) With Atrial Fibrillation (AISWAF) is a single-center prospective, consecutively, observational study, was conducted in patients with acute ischemic stroke/TIA with atrial fibrillation. The aim of this study was to understand the stroke mechanism, the regularity of stroke recurrence and its influencing factors, to establish a risk stratification model for stroke recurrence, and to preliminarily explore the relationship between stroke mechanism, risk stratification and antithrombotic regimen in this population.The clinical, imaging and laboratory information were collected at baseline. During the 1-year follow-up period, three months, six months and one year after admission, the patients were followed up by telephone or face-to-face to record the status of antithrombotic therapy, compliance, functional status, recurrence of ischemic stroke, intracranial hemorrhage, major extracranial hemorrhage as well as other vascular events and deaths.

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
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age greater than or equal to 18 years old;
  • Acute ischemic stroke or TIA within 14 days of onset (including patients with hemorrhagic transformation of infarction)
  • Evidence of atrial fibrillation or newly discovered atrial fibrillation before onset (atrial fibrillation includes valvular and non-valvular, permanent, persistent or paroxysmal);
  • Sign informed consent and consent to follow-up for 1 year.

排除标准

  • 未提供

结局指标

主要结局

The rate of recurrent Ischemic stroke/TIA and symptomatic systemic embolism

时间窗: one year

recurrent ischemic stroke/TIA and symptomatic systemic embolism

次要结局

  • the rate of clinically relevant nonmajor bleeding(one year)
  • Neurological disability(one year)
  • The rate recurrent Ischemic stroke/TIA(one year)
  • the rate of vascular death(one year)
  • The rate of non-intracranial major hemorrhage(one year)
  • All cause death(one year)
  • The rate of symptomatic intracranial hemorrhage(one year)
  • the rate of hemorrhagic transformation and the rate of symptomatic hemorrhagic transformation(one month)
  • the rate of medication persistence with OAC therapy(one year)

研究者

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

Sufang Xue

principal investigator

Xuanwu Hospital, Beijing

研究点 (1)

Loading locations...

相似试验