NCT04080830

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

September 3, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

September 10, 2019

Status Verified

September 1, 2019

Enrollment Period

6 years

First QC Date

September 3, 2019

Last Update Submit

September 6, 2019

Conditions

Keywords

Registration StudyAcute Ischemic StrokeAtrial Fibrillation

Outcome Measures

Primary Outcomes (1)

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

    recurrent ischemic stroke/TIA and symptomatic systemic embolism

    one year

Secondary Outcomes (9)

  • The rate recurrent Ischemic stroke/TIA

    one year

  • The rate of symptomatic intracranial hemorrhage

    one year

  • The rate of non-intracranial major hemorrhage

    one year

  • the rate of hemorrhagic transformation and the rate of symptomatic hemorrhagic transformation

    one month

  • the rate of vascular death

    one year

  • +4 more secondary outcomes

Study Arms (1)

Acute ischemic stroke/transient ischemic attack (TIA) with AF

patients with Acute ischemic stroke/TIA and Atrial fibrillation (observational -no intervention)

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Acute Ischemic Stroke/TIA With Atrial Fibrillation

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sufang Xue

Beijing, Beijing Municipality, 100053, China

RECRUITING

MeSH Terms

Conditions

Ischemic StrokeAtrial Fibrillation

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesArrhythmias, CardiacHeart DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

sufang xue, PHD,MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 3, 2019

First Posted

September 6, 2019

Study Start

January 1, 2016

Primary Completion

December 30, 2021

Study Completion

December 30, 2021

Last Updated

September 10, 2019

Record last verified: 2019-09

Locations