Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anticoagulation Therapy | Experimental | Participants in this arm will receive early initiation of direct oral anticoagulants (DOACs) following an individualized clinical assessment. Initiation is contingent upon the exclusion of hemorrhagic transformation via head CT/SWI within 24 hours prior to treatment. |
|
| Non-Anticoagulation Therapy | Active Comparator | Participants will not receive oral anticoagulation therapy during the study period. Patients may be prescribed single antiplatelet therapy (e.g., aspirin or clopidogrel) or no antithrombotic therapy, strictly at the discretion of the treating physician based on current clinical guidelines and individual patient risk profiles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Direct Oral Anticoagulants (DOACs) | Drug | Administration of approved DOACs (e.g., apixaban, rivaroxaban, edoxaban, or dabigatran) at standard stroke prevention dosages. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Recurrent Ischemic Stroke | Proportion of participants experiencing a recurrent acute ischemic stroke. | Up to 12 months. |
| Incidence of Recurrent Intracerebral Hemorrhage (ICH) | Proportion of participants experiencing a recurrent spontaneous ICH. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min Lou, PhD, MD | Contact | 8613958007213 | lm99@zju.edu.cn | |
| Wansi Zhong, MD | Contact | 8618757155806 | 21718233@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Min Lou, PhD, MD | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Antiplatelet Therapy or No Antithrombotic Therapy | Drug | Administration of single antiplatelet agents or avoidance of antithrombotic therapy, representing the current variable standard of care. |
|
| Up to 12 months. |
| Time to First Occurrence of Recurrent Ischemic Stroke | Time interval from randomization to the confirmed diagnosis of a recurrent ischemic stroke. | Up to 12 months |
| Time to First Occurrence of Recurrent Intracerebral Hemorrhage (ICH) | Time interval from randomization to the confirmed diagnosis of a recurrent ICH. | Up to 12 months |
| Incidence of Vascular Death | Proportion of participants who die from vascular causes (e.g., fatal stroke, fatal myocardial infarction). | Up to 12 months |
| All-Cause Mortality Rate | Proportion of participants who die from any cause during the follow-up period. | Up to 12 months |
| Incidence of Major Bleeding Events | Proportion of participants experiencing a major bleeding event, defined strictly according to the International Society on Thrombosis and Haemostasis (ISTH) criteria. | Up to 12 months |
| Incidence of Clinically Relevant Non-Major (CRNM) Bleeding | 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. | Up to 12 months |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D002543 | Cerebral Hemorrhage |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020300 | Intracranial Hemorrhages |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C065145 | N(4)-oleylcytosine arabinoside |
Not provided
Not provided
Not provided