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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000013932
Receipt No. R000016247
Scientific 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)
Date of disclosure of the study information 2014/05/12
Last modified on 2014/05/12

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Basic information
Public 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)
Acronym RELAXED: Recurrent Embolism Lessened by Rivaroxaban for Acute Ischemic Stroke
Scientific 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)
Scientific Title:Acronym RELAXED: Recurrent Embolism Lessened by Rivaroxaban for Acute Ischemic Stroke
Region
Japan

Condition
Condition Stroke, Acute TIA
Non-valvular Atrial Fibrillation
Classification by specialty
Cardiology Neurology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of the study is to evaluate the efficacy and safety of an oral direct activated coagulation factor Xa inhibitor, rivaroxaban, for acute ischemic stroke patients with non-valvular atrial fibrillation 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes 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)
Key secondary outcomes 1) ischemic stroke and transient ischemic attack
2) 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) Any bleeding events
4) Intracranial hemorrhage
5) Hemorrhagic transformation of cerebral infarcts
6) Adverse event
7) Recurrence of ischemic stroke and major bleeding according to whether or not heparin is administered
8) Recurrence of ischemic stroke and major bleeding according to whether rivaroxaban is administered in the morning or evening
9) Duration of hospitalization
10) Safety and efficacy of rivaroxaban administration via tube or by crush tablet
11) Definite clinical data on patients developing recurrent ischemic stroke or intracranial hemorrhage during rivaroxaban medication
12) Medical expenditures using a model

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Clinical diagnosis of acute ischemic stroke or transient ischemic attack (TIA)
2) Having non-valvular atrial fibrillation
3) 20 years or older
4) Visiting the clinic/hospital within 48 hours of the onset of acute ischemic stroke or TIA
5) Identification of an infarct in the middle cerebral artery (MCA) territory (symptoms ascribable to ischemia in the MCA territory in TIA patients)
6) Initiation of treatment with rivaroxaban within 30 days of the onset of acute ischemic stroke or TIA
7) Written informed consent by patients or their legally acceptable representative
Key exclusion criteria 1) hypersensitivity to rivaroxaban
2) Active bleeding (clinically significant hemorrhage) including gastrointestinal hemorrhage
3) liver disease complicated with coagulation disorder
4) liver disorder corresponding to Child-Pugh Class B or C
5) renal failure (creatinine clearance: <15 mL/minute)
6) poorly controlled hypertension (higher than 180/100)
7) Woman who are or are likely to be pregnant
8) Ongoing treatment with HIV protease inhibitors including ritonavir, atazanavir and indinavir
9) Ongoing treatment with itraconazole, voriconazole and ketoconazole
10) Active bacterial endocarditis
11) Patients considered by the investigator to be unsuitable for participating in this study
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo Minematsu, M.D.
Organization National Cerebral and Cardiovascular Center
Japan Cardiovascular Research Foundation
Division name Deputy Director General of the Hospital
Zip code
Address 5-7-1 Fujishiro-dai, Suita, Osaka, Japan
TEL 06-6833-5012
Email kminemat@ncvc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoko Matsumoto
Organization Japan Cardiovascular Research Foundation, and National Cerebral and Cardiovascular Center
Division name Secretariat
Zip code
Address 5-7-1 Fujishiro-dai, Suita, Osaka, Japan
TEL 06-6872-0010
Homepage URL http://portal.e-trial.co.jp/relaxed/
Email relaxed@jcvrf.jp

Sponsor
Institute Japan Cardiovascular Research Foundation, and National Cerebral and Cardiovascular Center
Institute
Department

Funding Source
Organization Bayer Yakuhin, Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT02129920
Org. issuing International ID_1 ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 国立循環器病研究センター(大阪府)、東京女子医科大学病院(東京都)、国立病院機構九州医療センター(福岡県)、国立病院機構名古屋医療センター(愛知県)、川崎医科大学附属病院(岡山県)、埼玉医科大学国際医療センター(埼玉県)、岩手医科大学附属病院(岩手県)、熊本市民病院(熊本県)、聖マリアンナ医科大学病院(神奈川県)、北海道大学病院(北海道)、広島大学病院(広島県)、兵庫医科大学病院(兵庫県)、他、約100施設

National Cerebral and Cardiovascular Center (Osaka), Tokyo Women’s Medical University Hospital (Tokyo), NHO Kyushu Medical Center (Fukuoka), NHO Nagoya Medical Center (Aichi),Kawasaki Medical School Hospital (Okayama), Saitama Medical University International Medical Center(Saitama), Iwate Medical University Hospital (Iwate), Kumamoto City Hospital(Kumamoto),St Marianna University School of Medicine Hospital (Kanagawa),Hokkaido University Hospital (Hokkaido), Hiroshima University Hospital (Hiroshima), The Hospital of Hyogo College of Medicine(Hyogo), and 100 medical institutes approximately

Other administrative information
Date of disclosure of the study information
2014 Year 05 Month 12 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2013 Year 12 Month 12 Day
Date of IRB
Anticipated trial start date
2014 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 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.

Management information
Registered date
2014 Year 05 Month 12 Day
Last modified on
2014 Year 05 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016247

Research Plan
Registered date File name

Research case data specifications
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Research case data
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