Oral Anticoagulation After Stroke With Prior ICH in Subjects With AF

A Prospective, Multicenter, Randomized Controlled Trial of Anticoagulation Therapy After Ischemic Stroke in Patients With Previous Intracerebral Hemorrhage and Atrial Fibrillation

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.

Inclusion Criteria:

1. Age ≥ 18 years.
2. Diagnosis of acute ischemic stroke, with no evidence of hemorrhagic transformation confirmed by acute neuroimaging (MRI and CT).
3. Documented history of spontaneous intracerebral hemorrhage (ICH).
4. Confirmed non-valvular atrial fibrillation (including paroxysmal, persistent, or permanent subtypes).
5. Provision of written informed consent by the patient or a legally authorized representative.

Exclusion Criteria:

1. Severe baseline disability, defined as a pre-stroke Modified Rankin Scale (mRS) score > 4.
2. Intracerebral hemorrhage definitively caused by underlying structural vascular lesions (e.g., AVM, aneurysm) or systemic diseases.
3. Severe, uncontrolled hypertension refractory to medical therapy.
4. Severe renal impairment, defined as an estimated Creatinine Clearance (CrCl) < 30 mL/min.
5. Clinical indications necessitating continuous oral anticoagulation therapy other than atrial fibrillation (e.g., mechanical prosthetic heart valves, deep vein thrombosis, pulmonary embolism).
6. Documented contraindications to direct oral anticoagulants according to the product summary of characteristics (excluding the previous spontaneous ICH), including but not limited to hypersensitivity, active clinically significant bleeding, high-risk bleeding lesions, or hepatic disease associated with coagulopathy and clinically relevant bleeding risk.
7. Prior deployment of, or planned procedure for, a left atrial appendage occlusion (LAAO) device.
8. Women who are pregnant, breastfeeding, or planning to become pregnant during the trial period.
9. Estimated life expectancy of less than 1 year due to concomitant terminal illness.