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Early recurrence of cardioembolic stroke in patients with atrial fibrillation is common, reaching approximately 6% within 30 days after initial stroke. Therefore, it is preferable to provide early anticoagulation for cardioembolic stroke. However, early anticoagulation may increase the risk of hemorrhagic transformation of cerebral infarcts. It is difficult to decide the timing of initiation for anticoagulant therapy in stroke patients with non-valvular atrial fibrillation (NVAF). In 2013 the European Heart Rhythm Association presented the practical guides for oral anticoagulants in NVAF patients, which recommend that the optimal time to start anticoagulant therapy should be determined according to the stroke severity. However, this recommendation is principally an experts' opinion and is not suitable in the clinical practice in Japan.
RELAXED, a multicenter observational study is planned to evaluate the efficacy and safety of an oral direct activated coagulation factor Xa inhibitor, rivaroxaban, for acute ischemic stroke patients with NVAF in consideration of the infarct size, timing of initiation for rivaroxaban medication, and other patient characteristics, and thereby to determine the optimal timing of the initiation during acute ischemic stroke. The consecutive acute ischemic stroke / transient ischemic attack (TIA) patients with NVAF who are treated with rivaroxaban will be enrolled. The infarction size at 0-48 hours after stroke onset will be measured by the diffusion weighted image (DWI) MRI. The primary efficacy endpoint is recurrent ischemic stroke within 3 months. The primary safety endpoint is major bleedings within 3 months. The optimal timing to initiate rivaroxaban during acute ischemic stroke is determined by analysis of co-relation between primary endpoints and the infarct size / time to initiate rivaroxaban.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NVAF, acute ischemic stroke/TIA | Consecutive acute ischemic stroke/TIA patients with nonvalvular atrial fibrillation and treated with rivaroxaban |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| This is an observational study | Other |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 3 monhths |
| Measure | Description | Time Frame |
|---|---|---|
| ischemic stroke and transient ischemic attack | 3 months | |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive acute ischemic stroke/TIA patients with nonvalvular atrial fibrillation and treated with rivaroxaban
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Satoko Matsumoto | Contact | +81-6-6872-0010 | relaxed@jcvrf.jp | |
| Minoru Ido | Contact | +81-6-4807-3015 | prj-relaxed_cont@eps.co.jp |
| Name | Affiliation | Role |
|---|---|---|
| Kazuo Minematsu, M.D. | Japan Cardiovascular Research Foundation, and National Cerebral and Cardiovascular Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Japan Cardiovascular Research Foundation | Recruiting | Suita | Osaka | 565-8565 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35385480 | Derived | Koge J, Yamagami H, Toyoda K, Yasaka M, Hirano T, Hamasaki T, Nagao T, Yoshimura S, Fujishige M, Tempaku A, Uchiyama S, Mori E, Koga M, Minematsu K. Early initiation of rivaroxaban after reperfusion therapy for stroke patients with nonvalvular atrial fibrillation. PLoS One. 2022 Apr 6;17(4):e0264760. doi: 10.1371/journal.pone.0264760. eCollection 2022. | |
| 26987488 |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D001281 | Atrial Fibrillation |
| D002544 | Cerebral Infarction |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D020520 | Brain Infarction |
| D002545 | Brain Ischemia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007238 | Infarction |
| D007511 | Ischemia |
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| 3 months |
| Any bleeding events | 3 months |
| Intracranial hemorrhage | 3 months |
| Hemorrhagic transformation of cerebral infarcts | 3 months |
| Adverse event | 3 month |
| Recurrence of ischemic stroke and major bleeding according to whether or not heparin is administered | 3 months |
| Recurrence of ischemic stroke and major bleeding according to whether rivaroxaban is administered in the morning or evening | 3 month |
| Duration of hospitalization | 3 month |
| Safety and efficacy of rivaroxaban administration via tube or by crush tablet | 3 month |
| Definite clinical data on patients developing recurrent ischemic stroke or intracranial hemorrhage during rivaroxaban medication | 3 month |
| Medical expenditures using a model | 3 month |
| Yasaka M, Minematsu K, Toyoda K, Yamagami H, Yoshimura S, Nagao T, Mori E, Hirano T, Hamasaki T, Yamaguchi T. Design and Rationale of the RELAXED (Recurrent Embolism Lessened by rivaroxaban, an Anti-Xa agent, of Early Dosing for acute ischemic stroke and transient ischemic attack with atrial fibrillation) Study. J Stroke Cerebrovasc Dis. 2016 Jun;25(6):1342-8. doi: 10.1016/j.jstrokecerebrovasdis.2016.01.035. Epub 2016 Mar 14. |
| D009336 |
| Necrosis |