Oral Anticoagulation After Stroke With Prior ICH in Subjects With AF
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years.
Diagnosis of acute ischemic stroke, with no evidence of hemorrhagic transformation confirmed by acute neuroimaging (MRI and CT).
Documented history of spontaneous intracerebral hemorrhage (ICH).
Confirmed non-valvular atrial fibrillation (including paroxysmal, persistent, or permanent subtypes).
Disqualifiers
Severe baseline disability, defined as a pre-stroke Modified Rankin Scale (mRS) score > 4.
Intracerebral hemorrhage definitively caused by underlying structural vascular lesions (e.g., AVM, aneurysm) or systemic diseases.
Severe, uncontrolled hypertension refractory to medical therapy.
Severe renal impairment, defined as an estimated Creatinine Clearance (CrCl) < 30 mL/min.
Trial design
Design model
Parallel
Treatments tested in this trial
Direct Oral Anticoagulants (DOACs)
DrugAdministration of approved DOACs (e.g., apixaban, rivaroxaban, edoxaban, or dabigatran) at standard stroke prevention dosages.
Antiplatelet Therapy or No Antithrombotic Therapy
DrugAdministration of single antiplatelet agents or avoidance of antithrombotic therapy, representing the current variable standard of care.
Treatment groups
852 Participants
are divided into 2 treatment groupsGroup A: Anticoagulation TherapyExperimental treatment 1 intervention
Group B: Non-Anticoagulation TherapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
Incidence of Recurrent Ischemic Stroke
Proportion of participants experiencing a recurrent acute ischemic stroke.
Time frame
Up to 12 months.2
Incidence of Recurrent Intracerebral Hemorrhage (ICH)
Proportion of participants experiencing a recurrent spontaneous ICH.
Time frame
Up to 12 months.3
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 months4
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 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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