Recurrent Embolism Lessened by Rivaroxaban, an Anti-Xa Agent of Early Dosing for Acute Ischemic Stroke and Transient Ischemic Attack With Atrial Fibrillation Study (RELAXED)
Not Applicable
Recruiting
- Conditions
- Stroke, Acute TIA Non-valvular Atrial Fibrillation
- Registration Number
- JPRN-UMIN000013932
- Lead Sponsor
- Japan Cardiovascular Research Foundation, and National Cerebral and Cardiovascular Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 2000
Inclusion Criteria
Not provided
Exclusion Criteria
1) hypersensitivity to rivaroxaban 2) Active bleeding (clinically significant hemorrhage) including gastrointestinal hemorrhage 3) liver disease complicated with coagulation disorder 4) liver disorder corresponding to Child-Pugh Class B or C 5) renal failure (creatinine clearance: <15 mL/minute) 6) poorly controlled hypertension (higher than 180/100) 7) Woman who are or are likely to be pregnant 8) Ongoing treatment with HIV protease inhibitors including ritonavir, atazanavir and indinavir 9) Ongoing treatment with itraconazole, voriconazole and ketoconazole 10) Active bacterial endocarditis 11) Patients considered by the investigator to be unsuitable for participating in this study
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Recurrent ischemic stroke and major bleeding The optimal timing to start treatment with rivaroxaban of the initiation for during acute ischemic stroke are determined by analysis of co-relation between primary endpoints including recurrent ischemic stroke / major bleeding, and the cerebral infarction size / time to start treatment with rivaroxaban. Major bleeding according to the criteria by the International Society of Thrombosis and Haemostasis (ISTH)
- Secondary Outcome Measures
Name Time Method 1) ischemic stroke and transient ischemic attack 2) Composite cardiovascular events The composite cardiovascular events are included ischemic stroke, TIA, systemic embolism, acute coronary syndrome, deep vein thrombosis, pulmonary embolism, other ischemic disease, revascularization, total death, cardiovascular death 3) Any bleeding events 4) Intracranial hemorrhage 5) Hemorrhagic transformation of cerebral infarcts 6) Adverse event 7) Recurrence of ischemic stroke and major bleeding according to whether or not heparin is administered 8) Recurrence of ischemic stroke and major bleeding according to whether rivaroxaban is administered in the morning or evening 9) Duration of hospitalization 10) Safety and efficacy of rivaroxaban administration via tube or by crush tablet 11) Definite clinical data on patients developing recurrent ischemic stroke or intracranial hemorrhage during rivaroxaban medication 12) Medical expenditures using a model