RELAXED: Recurrent Embolism Lessened by Rivaroxaban for Acute Ischemic Stroke (RELAXED)
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|ClinicalTrials.gov Identifier: NCT02129920|
Recruitment Status : Unknown
Verified April 2014 by Kazuo Minematsu, Japan Cardiovascular Research Foundation.
Recruitment status was: Recruiting
First Posted : May 2, 2014
Last Update Posted : May 2, 2014
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.
|Condition or disease||Intervention/treatment|
|Stroke, Acute Atrial Fibrillation||Other: This is an observational study|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||2000 participants|
|Target Follow-Up Duration:||3 Months|
|Official Title:||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)|
|Study Start Date :||February 2014|
|Estimated Primary Completion Date :||May 2016|
|Estimated Study Completion Date :||May 2016|
NVAF, acute ischemic stroke/TIA
Consecutive acute ischemic stroke/TIA patients with nonvalvular atrial fibrillation and treated with rivaroxaban
Other: This is an observational study
Other Name: This is an observational, not intervention, study.
- Recurrent ischemic stroke and major bleeding [ Time Frame: 3 monhths ]
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)
- ischemic stroke and transient ischemic attack [ Time Frame: 3 months ]
- Composite cardiovascular events [ Time Frame: 3 months ]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
- Any bleeding events [ Time Frame: 3 months ]
- Intracranial hemorrhage [ Time Frame: 3 months ]
- Hemorrhagic transformation of cerebral infarcts [ Time Frame: 3 months ]
- Adverse event [ Time Frame: 3 month ]
- Recurrence of ischemic stroke and major bleeding according to whether or not heparin is administered [ Time Frame: 3 months ]
- Recurrence of ischemic stroke and major bleeding according to whether rivaroxaban is administered in the morning or evening [ Time Frame: 3 month ]
- Duration of hospitalization [ Time Frame: 3 month ]
- Safety and efficacy of rivaroxaban administration via tube or by crush tablet [ Time Frame: 3 month ]
- Definite clinical data on patients developing recurrent ischemic stroke or intracranial hemorrhage during rivaroxaban medication [ Time Frame: 3 month ]
- Medical expenditures using a model [ Time Frame: 3 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02129920
|Contact: Satoko Matsumotofirstname.lastname@example.org|
|Contact: Minoru Idoemail@example.com|
|Japan Cardiovascular Research Foundation||Recruiting|
|Suita, Osaka, Japan, 565-8565|
|Contact: Satoko Matsumoto +81-6-6872-0010 firstname.lastname@example.org|
|Contact: Minoru Ido +81-6-4807-3015 email@example.com|
|Principal Investigator:||Kazuo Minematsu, M.D.||Japan Cardiovascular Research Foundation, and National Cerebral and Cardiovascular Center|