This prospective, multicenter, randomized controlled trial aims to evaluate the efficacy and safety of initiating direct oral anticoagulants (DOACs) in patients with a history of spontaneous intracerebral hemorrhage (ICH) and non-valvular atrial fibrillation (AF) who have recently suffered an acute ischemic stroke. Existing evidence regarding the optimal antithrombotic strategy for this specific high-risk "double-jeopardy" population remains largely undefined. Eligible participants will be randomized in a 1:1 ratio to either receive oral anticoagulation therapy or a non-anticoagulation standard of care. The primary objective is to assess the incidence of a composite endpoint consisting of recurrent ischemic stroke and recurrent ICH over a 12-month follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
852
Administration of approved DOACs (e.g., apixaban, rivaroxaban, edoxaban, or dabigatran) at standard stroke prevention dosages.
Administration of single antiplatelet agents or avoidance of antithrombotic therapy, representing the current variable standard of care.
Incidence of the Composite Endpoint of Recurrent Stroke
Proportion of participants experiencing a recurrent ischemic stroke or a recurrent intracerebral hemorrhage (ICH). Events will be adjudicated by independent, blinded clinical assessors.
Time frame: Up to 12 months
Incidence of Recurrent Ischemic Stroke
Proportion of participants experiencing a recurrent acute ischemic stroke.
Time frame: Up to 12 months.
Incidence of Recurrent Intracerebral Hemorrhage (ICH)
Proportion of participants experiencing a recurrent spontaneous ICH.
Time frame: Up to 12 months.
Time to First Occurrence of Recurrent Ischemic Stroke
Time interval from randomization to the confirmed diagnosis of a recurrent ischemic stroke.
Time frame: Up to 12 months
Time to First Occurrence of Recurrent Intracerebral Hemorrhage (ICH)
Time interval from randomization to the confirmed diagnosis of a recurrent ICH.
Time frame: Up to 12 months
Incidence of Vascular Death
Proportion of participants who die from vascular causes (e.g., fatal stroke, fatal myocardial infarction).
Time frame: Up to 12 months
All-Cause Mortality Rate
Proportion of participants who die from any cause during the follow-up period.
Time frame: Up to 12 months
Incidence of Major Bleeding Events
Proportion of participants experiencing a major bleeding event, defined strictly according to the International Society on Thrombosis and Haemostasis (ISTH) criteria.
Time frame: Up to 12 months
Incidence of Clinically Relevant Non-Major (CRNM) Bleeding
Proportion of participants experiencing bleeding events that do not meet the ISTH criteria for major bleeding but result in medical intervention, hospitalization, or discontinuation of the study drug.
Time frame: Up to 12 months
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