RELAXED: Recurrent Embolism Lessened by Rivaroxaban for Acute Ischemic Stroke "RELAXED"

Recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • This is an observational study Other
    Other Names: This is an observational, not intervention, study.
    ARM 1: Kind: Experimental
    Label: NVAF, acute ischemic stroke/TIA
    Description: Consecutive acute ischemic stroke/TIA patients with nonvalvular atrial fibrillation and treated with rivaroxaban

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial Population

Consecutive acute ischemic stroke/TIA patients with nonvalvular atrial fibrillation and treated with rivaroxaban

Outcomes

Type Measure Time Frame Safety Issue
Primary Recurrent ischemic stroke and major bleeding 3 monhths Yes
Secondary ischemic stroke and transient ischemic attack 3 months No
Secondary Composite cardiovascular events 3 months Yes
Secondary Any bleeding events 3 months Yes
Secondary Intracranial hemorrhage 3 months Yes
Secondary Hemorrhagic transformation of cerebral infarcts 3 months Yes
Secondary Adverse event 3 month Yes
Secondary Recurrence of ischemic stroke and major bleeding according to whether or not heparin is administered 3 months Yes
Secondary Recurrence of ischemic stroke and major bleeding according to whether rivaroxaban is administered in the morning or evening 3 month Yes
Secondary Duration of hospitalization 3 month No
Secondary Safety and efficacy of rivaroxaban administration via tube or by crush tablet 3 month Yes
Secondary Definite clinical data on patients developing recurrent ischemic stroke or intracranial hemorrhage during rivaroxaban medication 3 month Yes
Secondary Medical expenditures using a model 3 month No

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