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
Qualifiers
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
Treatments tested in this trial
- Direct Oral Anticoagulants (DOACs)
- Antiplatelet Therapy or No Antithrombotic Therapy
Treatment groups
852 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov