RELAXED: Recurrent Embolism Lessened by Rivaroxaban for Acute Ischemic Stroke (RELAXED)

May 1, 2014 updated by: Kazuo Minematsu, Japan Cardiovascular Research Foundation

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)

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.

Study Overview

Status

Unknown

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Osaka
      • Suita, Osaka, Japan, 565-8565
        • Recruiting
        • Japan Cardiovascular Research Foundation
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
NVAF, acute ischemic stroke/TIA
Consecutive acute ischemic stroke/TIA patients with nonvalvular atrial fibrillation and treated with rivaroxaban
Other Names:
  • This is an observational, not intervention, study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)

3 monhths

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ischemic stroke and transient ischemic attack
Time Frame: 3 months
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
3 months
Any bleeding events
Time Frame: 3 months
3 months
Intracranial hemorrhage
Time Frame: 3 months
3 months
Hemorrhagic transformation of cerebral infarcts
Time Frame: 3 months
3 months
Adverse event
Time Frame: 3 month
3 month
Recurrence of ischemic stroke and major bleeding according to whether or not heparin is administered
Time Frame: 3 months
3 months
Recurrence of ischemic stroke and major bleeding according to whether rivaroxaban is administered in the morning or evening
Time Frame: 3 month
3 month
Duration of hospitalization
Time Frame: 3 month
3 month
Safety and efficacy of rivaroxaban administration via tube or by crush tablet
Time Frame: 3 month
3 month
Definite clinical data on patients developing recurrent ischemic stroke or intracranial hemorrhage during rivaroxaban medication
Time Frame: 3 month
3 month
Medical expenditures using a model
Time Frame: 3 month
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kazuo Minematsu, M.D., Japan Cardiovascular Research Foundation, and National Cerebral and Cardiovascular Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Anticipated)

May 1, 2016

Study Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

May 1, 2014

First Submitted That Met QC Criteria

May 1, 2014

First Posted (Estimate)

May 2, 2014

Study Record Updates

Last Update Posted (Estimate)

May 2, 2014

Last Update Submitted That Met QC Criteria

May 1, 2014

Last Verified

April 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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