Clinical trial NCT04080830: Registration Study of Acute Ischemic Stroke/Transient Ischemic Attack (TIA) With Atrial Fibrillation
Official title: Patient Registration Study of Acute Ischemic Stroke/Transient Ischemic Attack(TIA ) With Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Ischemic Stroke
Atrial Fibrillation
Keywords: Registration Study
Acute Ischemic Stroke
Atrial Fibrillation
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute Ischemic Stroke/TIA With Atrial Fibrillation

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.

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:

-

Primary outcomes:
measure: The rate of recurrent Ischemic stroke/TIA and symptomatic systemic embolism
timeFrame: one year
Secondary outcomes:
measure: The rate recurrent Ischemic stroke/TIA
timeFrame: one year
measure: The rate of symptomatic intracranial hemorrhage
timeFrame: one year
measure: The rate of non-intracranial major hemorrhage
timeFrame: one year
measure: the rate of hemorrhagic transformation and the rate of symptomatic hemorrhagic transformation
timeFrame: one month
measure: the rate of vascular death
timeFrame: one year
measure: All cause death
timeFrame: one year
measure: the rate of clinically relevant nonmajor bleeding
timeFrame: one year
measure: Neurological disability
timeFrame: one year
measure: the rate of medication persistence with OAC therapy
timeFrame: one year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Sufang Xue
state: Beijing
Study officials:
References: