About this trial
The main purpose of this study is to investigate the safety and outcomes of different treatment strategies, including best medical therapy (OAC \[oral anticoagulation\], antiplatelet \[APT\]) and left atrial appendage closure \[LAAC\] in acute ischemic stroke (AIS) patients with atrial fibrillation (AF) based on multimodal assessment from combined brain and cardiologic work-up, and to optimize secondary prevention.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age > 18 years old;
Acute ischemic stroke with onset ≤ 14 days;
Previously or during this hospitalization diagnosed with non-valvular atrial fibrillation;
Informed consent obtained from the patient or his/her legal representative;
Disqualifiers
Pacemaker, implantable cardioverter defibrillator or implantable cardiac monitor;
Left atrial appendage has been removed or post occlusion device implantation;
Transient AF secondary to other reversible disorders;
Life expectancy less than 1 year;
Trial population
Adult patients who had acute ischemic stroke symptoms within 7 days and previously or during this hospitalization diagnosed with non-valvular atrial fibrillation.
Trial design
Cohort
Prospective
Treatments tested in this trial
Cardiologic work-up
Diagnostic testNoninvasive prolonged ECG monitoring with a duration of 7 days measuring AF burden; Echocardiography measuring LA volume or volume index, LA diameter or diameter index; Cardiac CTA measuring LAA morphologies, cardiac thrombus.
Treatment groups
Trial outcomes
Primary outcomes
Composite endpoints of ischemic stroke, systemic embolism, myocardial infarction, major bleeding (BARC type 3-5) and all-cause mortality
Stroke only including ischemic stroke
Secondary outcomes
Composite endpoints of stroke, systemic embolism, myocardial infarction, major bleeding (BARC type 3-5) and all-cause mortality
Stroke including ischemic or hemorrhagic stroke
Other outcomes
Ischemic stroke
Rapid onset of a new focal neurological deficit with clinical and imaging evidence of infarction and not attributable to a non-ischemic etiology.
Hemorrhagic stroke
Hemorrhagic stroke is defined as an acute episode of focal or global cerebral or spinal dysfunction caused by a nontraumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage
Systemic embolism
Systemic embolism was defined as an acute vascular occlusion of an extremity or organ confirmed by imaging or either surgery or autopsy.
Myocardial infarction (MI)
Myocardial infarction will be assessed according to the third universal definition of myocardial infarction (Eur Heart J, 2012).
Sponsors and contacts
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