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

NCT ID: NCT04080830

Last Updated: 2019-09-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2021-12-30

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.

Detailed Description

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.

Conditions

Acute Ischemic Stroke; Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Sufang Xue

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sufang Xue

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

sufang xue, PHD，MD

Role: CONTACT

xuesufang@xwhosp.org

8613810496895 ext. 8613810496895

Facility Contacts

sufang xue

Role: primary

xuesufang@xwhosp.org

8613810496895 ext. 8613810496895

Other Identifiers

ID-8849

Identifier Type: -

Identifier Source: org_study_id