Oral Anticoagulation After Stroke With Prior ICH in Subjects With AF

Starting soon · Phase 4

Conditions studied: Acute Ischemic Stroke, Intracerebral Hemorrhage, Atrial Fibrillation (AF)

In brief

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.

Key facts

Study ID

NCT07609654

Run by

Second Affiliated Hospital, Zhejiang University, School of Medicine

People needed

852

Starts

2026-06-01

Expected to finish

2029-09-01

Last updated by the study team

2026-05-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).
• Provision of written informed consent by the patient or a legally authorized representative.

You may not qualify if…

• 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.
• Clinical indications necessitating continuous oral anticoagulation therapy other than atrial fibrillation (e.g., mechanical prosthetic heart valves, deep vein thrombosis, pulmonary embolism).
• 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.
• Prior deployment of, or planned procedure for, a left atrial appendage occlusion (LAAO) device.
• Women who are pregnant, breastfeeding, or planning to become pregnant during the trial period.
• Estimated life expectancy of less than 1 year due to concomitant terminal illness.

Full record on ClinicalTrials.gov

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