Patients with symptomatic intracranial hemorrhage (ICH) and non-valvular atrial fibrillation (NVAF)
Conditions
Interventions
None listed
Sponsors
National Cerebral and Cardiovascular Center Department of Cerebrovascular Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) With symptomatic ICH (*See below) 2) Given the definitive diagnosis of NVAF and who are scheduled to resume/are resumed DOAC within 14 days after ICH occurrence 3) Obtaining written informed consent from the patient or his/her representative 4) Age >= 20 years at the time of signing the informed consent - Eligibility of patients with different subtypes of ICH 1. Intrinsic (intraparenchymal hemorrhage, intraventricular hemorrhage, acute epidural hematoma, acute subdural hematoma): Eligible 2. Traumatic (intraparenchymal hemorrhage, intraventricular hemorrhage, acute epidural hematoma, acute subdural hematoma): Eligible 3. Amyloid angiopathy (intraparenchymal hemorrhage, intraventricular hemorrhage): Eligible
Exclusion criteria
Exclusion criteria: 1) ICH caused by diagnosed vascular lesions such as cerebral aneurysm, cerebral arteriovenous malformation, cavernous hemangioma, dural arteriovenous fistula, cerebral venous vascular malformation, cerebral venous sinus thrombosis, and neoplastic or infectious 2) Patients with aneurysmal subarachnoid hemorrhage and traumatic subarachnoid hemorrhage without subdural or intracerebral hematoma, and patients with chronic subdural hematoma 3) Patients with a history of ICH within the past 3 months of current ICH onset 4) Patients with pre-morbid modified Rankin Scale of 5 5) Patients planning left atrial appendage closure treatment 6) Patients who meet the contraindications for each DOAC within 14 days of ICH onset 7) Patients requiring continuous oral anticoagulation for other diseases than AF (e.g., venous thromboembolism) 8) Patients who experienced a primary endpoint event specified in this study before informed consent 9) Pregnant or breastfeeding patients 10) Patients with an estimated life expectancy of less than 6 months at enrollment 11) Patients who are currently participating or scheduled to participate in clinical trials and intervention studies 12) Patients who are deemed inappropriate to participate in this study at the discretion of the physician in charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of these incidence rates up to 30 days after ICH - Symptomatic ICH - Symptomatic stroke - All-cause death | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Incidence rates of the following individual events up to 48 hours of DOAC administration (assessed by imaging) - Asymptomatic cerebral infarction - Asymptomatic ICH - Hematoma expansion (percentage of enlarged cases, central evaluation using CT images) 2) Incidence rates of the following individual events up to 30 days of DOAC administration - Symptomatic ICH - Symptomatic stroke - Symptomatic ischemic stroke - Symptomatic intraparenchymal hemorrhage - Systemic embolism - Major bleeding - All-cause death - Hematoma expansion (percentage of enlarged cases, central evaluation using CT images) 3) Incidence of the following composite events up to 3 and 12 months of DOAC administration - Symptomatic ICH - Symptomatic stroke - All-cause death 4) Incidence of individual events up to 3 and 12 months of DOAC administration - Symptomatic ICH - Symptomatic stroke - Symptomatic ischemic stroke - Symptomatic intraparenchymal hemorrhage - Systemic embolism - Major bleeding - All-cause death | — |
Countries
Japan
Contacts
Public ContactMasatoshi Koga
National Cerebral and Cardiovascular Center Department of Cerebrovascular Medicine
Outcome results
None listed