RELAXED: Recurrent Embolism Lessened by Rivaroxaban for Acute Ischemic Stroke

Atrial Fibrillation Clinical Trial

— RELAXED  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02129920
• Other study ID #: M25-113
• Status: Recruiting
• Phase: N/A
• First received: May 1, 2014
• Last updated: May 1, 2014
• Start date: February 2014
• Est. completion date: May 2016

Study information

• Verified date: April 2014
• Source: Japan Cardiovascular Research Foundation
• Contact: Satoko Matsumoto
• Phone: +81-6-6872-0010
• Email: relaxed[@]jcvrf.jp
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of acute ischemic stroke or transient ischemic attack (TIA)

• Having non-valvular atrial fibrillation

• Visiting the clinic/hospital within 48 hours of the onset of acute ischemic stroke or TIA

• Identification of an infarct in the middle cerebral artery (MCA) territory (symptoms ascribable to ischemia in the MCA territory in TIA patients)

• Initiation of treatment with rivaroxaban within 30 days of the onset of acute ischemic stroke or TIA

• Written informed consent by patients

Exclusion Criteria:

• hypersensitivity to rivaroxaban 2) Active bleeding (clinically significant hemorrhage) including gastrointestinal hemorrhage

• liver disease complicated with coagulation disorder

• liver disorder corresponding to Child-Pugh Class B or C

• renal failure (creatinine clearance: <15 mL/minute)

• poorly controlled hypertension (higher than 180/100)

• Woman who are or are likely to be pregnant

• Ongoing treatment with HIV protease inhibitors including ritonavir, atazanavir and indinavir

• Ongoing treatment with itraconazole, voriconazole and ketoconazole

• Active bacterial endocarditis

• Patients considered by the investigator to be unsuitable for participating in this study

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke
• Stroke, Acute

Intervention

Other:
• This is an observational study

Locations

Country	Name	City	State
Japan	Japan Cardiovascular Research Foundation	Suita	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Japan Cardiovascular Research Foundation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	ischemic stroke and transient ischemic attack		3 months	No
Secondary	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 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