Acute Ischemic Stroke, Atrial Fibrillation (AF), Intracerebral Hemorrhage
Conditions
Keywords
Acute Ischemic Stroke, Intracerebral Hemorrhage, Atrial Fibrillation (AF), DOACs, Anticoagulation
Brief summary
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.
Interventions
Administration of approved DOACs (e.g., apixaban, rivaroxaban, edoxaban, or dabigatran) at standard stroke prevention dosages.
DRUGAntiplatelet Therapy or No Antithrombotic Therapy
Administration of single antiplatelet agents or avoidance of antithrombotic therapy, representing the current variable standard of care.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of the Composite Endpoint of Recurrent Stroke | Up to 12 months | Proportion of participants experiencing a recurrent ischemic stroke or a recurrent intracerebral hemorrhage (ICH). Events will be adjudicated by independent, blinded clinical assessors. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Recurrent Ischemic Stroke | Up to 12 months. | Proportion of participants experiencing a recurrent acute ischemic stroke. |
| Incidence of Recurrent Intracerebral Hemorrhage (ICH) | Up to 12 months. | Proportion of participants experiencing a recurrent spontaneous ICH. |
| Time to First Occurrence of Recurrent Ischemic Stroke | Up to 12 months | Time interval from randomization to the confirmed diagnosis of a recurrent ischemic stroke. |
| Time to First Occurrence of Recurrent Intracerebral Hemorrhage (ICH) | Up to 12 months | Time interval from randomization to the confirmed diagnosis of a recurrent ICH. |
| Incidence of Vascular Death | Up to 12 months | Proportion of participants who die from vascular causes (e.g., fatal stroke, fatal myocardial infarction). |
| All-Cause Mortality Rate | Up to 12 months | Proportion of participants who die from any cause during the follow-up period. |
| Incidence of Major Bleeding Events | Up to 12 months | Proportion of participants experiencing a major bleeding event, defined strictly according to the International Society on Thrombosis and Haemostasis (ISTH) criteria. |
| Incidence of Clinically Relevant Non-Major (CRNM) Bleeding | Up to 12 months | 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. |
Contacts
CONTACTMin Lou, PhD, MD
CONTACTWansi Zhong, MD
PRINCIPAL_INVESTIGATORMin Lou, PhD, MD
Second Affiliated Hospital, School of Medicine, Zhejiang University
Outcome results
None listed