- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02129920
RELAXED: Recurrent Embolism Lessened by Rivaroxaban for Acute Ischemic Stroke (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 (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
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Satoko Matsumoto
- Phone Number: +81-6-6872-0010
- Email: relaxed@jcvrf.jp
Study Contact Backup
- Name: Minoru Ido
- Phone Number: +81-6-4807-3015
- Email: prj-relaxed_cont@eps.co.jp
Study Locations
-
-
Osaka
-
Suita, Osaka, Japan, 565-8565
- Recruiting
- Japan Cardiovascular Research Foundation
-
Contact:
- Satoko Matsumoto
- Phone Number: +81-6-6872-0010
- Email: relaxed@jcvrf.jp
-
Contact:
- Minoru Ido
- Phone Number: +81-6-4807-3015
- Email: prj-relaxed_cont@eps.co.jp
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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:
|
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
Investigators
- Principal Investigator: Kazuo Minematsu, M.D., Japan Cardiovascular Research Foundation, and National Cerebral and Cardiovascular Center
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Stroke
- Atrial Fibrillation
- Vascular Diseases
- Cardiovascular Diseases
- Nervous System Diseases
- Central Nervous System Diseases
- Brain Diseases
- Heart Diseases
- Anticoagulants
- Therapeutic Uses
- Cerebral Infarction
- Cerebrovascular Disorders
- Brain Infarction
- Brain Ischemia
- Arrhythmias, Cardiac
- Hematologic Agents
Additional Relevant MeSH Terms
Other Study ID Numbers
- M25-113
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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