Stroke, AcuteRELAXEDNCT02129920
RELAXED: Recurrent Embolism Lessened by Rivaroxaban for Acute Ischemic Stroke
An observational study of Stroke, Acute and Atrial Fibrillation, run by Japan Cardiovascular Research Foundation at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Stroke, Acute, Atrial Fibrillation
- What is being tested?
- This is an observational study
- How many people
- 2,000 participants
- Where
- 1 siteJapan
- Study dates
- Feb 2014to May 2016
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive acute ischemic stroke/TIA patients with nonvalvular atrial fibrillation and treated with rivaroxaban
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Japan Cardiovascular Research Foundation
Suita, Osaka, 565-8565
Satoko Matsumoto, +81-6-6872-0010, relaxed@jcvrf.jp
Minoru Ido, +81-6-4807-3015, prj-relaxed_cont@eps.co.jp
About this study
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)
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
- Stroke, Acute, Atrial Fibrillation
- Being tested
- This is an observational study
- Keywords
- Stroke, Cerebral Infarction, Atrial Fibrillation, Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases, Brain Infarction, Brain Ischemia, Anticoagulants, Hematologic Agents, Therapeutic Uses
- Medical subject headings
- Stroke, Atrial Fibrillation, Cerebral Infarction, Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases, Cerebrovascular Disorders, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is an observational studyOther
Also called This is an observational, not intervention, study.
| Study group | Role | What they receive |
|---|---|---|
| NVAF, acute ischemic stroke/TIA | Consecutive acute ischemic stroke/TIA patients with nonvalvular atrial fibrillation and treated with rivaroxaban Receives: Other: This is an observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 monhths
Secondary outcomes (12)
ischemic stroke and transient ischemic attack
Measured: 3 months
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
Measured: 3 months
Any bleeding events
Measured: 3 months
Intracranial hemorrhage
Measured: 3 months
Hemorrhagic transformation of cerebral infarcts
Measured: 3 months
Adverse event
Measured: 3 month
Recurrence of ischemic stroke and major bleeding according to whether or not heparin is administered
Measured: 3 months
Recurrence of ischemic stroke and major bleeding according to whether rivaroxaban is administered in the morning or evening
Measured: 3 month
Duration of hospitalization
Measured: 3 month
Safety and efficacy of rivaroxaban administration via tube or by crush tablet
Measured: 3 month
Definite clinical data on patients developing recurrent ischemic stroke or intracranial hemorrhage during rivaroxaban medication
Measured: 3 month
Medical expenditures using a model
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2014 (estimated)
- Study startFeb 2014
- Primary completionMay 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Japan Cardiovascular Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kazuo Minematsu, Japan Cardiovascular Research Foundation
- Investigators
- Kazuo Minematsu, M.D., Principal investigator, Japan Cardiovascular Research Foundation, and National Cerebral and Cardiovascular Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02129920
- Sponsor's protocol ID
- M25-113
- Acronym
- RELAXED
- Status last verified
- Apr 2014
- First submitted
- 1 May 2014
- Last updated
- 2 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 35385480Yasaka 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.
PubMed 26987488
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02129920
- Acronym / sponsor ID
- RELAXED / M25-113
- Conditions
- Stroke, Acute, Atrial Fibrillation
- Keywords
- Stroke, Cerebral Infarction, Atrial Fibrillation, Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases, Cerebrovascular Disorders, Brain Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Japan Cardiovascular Research FoundationUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 2 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NVAF, acute ischemic stroke/TIA | – | Other: This is an observational studyConsecutive acute ischemic stroke/TIA patients with nonvalvular atrial fibrillation and treated with rivaroxaban |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive acute ischemic stroke/TIA patients with nonvalvular atrial fibrillation and treated with rivaroxaban
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is an observational studyAlso: This is an observational, not intervention, study. | Other | NVAF, acute ischemic stroke/TIA |
Primary outcome
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)
12 secondary outcomes
ischemic stroke and transient ischemic attack
Time frame: 3 months
Composite cardiovascular events
Time frame: 3 months
Any bleeding events
Time frame: 3 months
Intracranial hemorrhage
Time frame: 3 months
Hemorrhagic transformation of cerebral infarcts
Time frame: 3 months
Adverse event
Time frame: 3 month
Recurrence of ischemic stroke and major bleeding according to whether or not heparin is administered
Time frame: 3 months
Recurrence of ischemic stroke and major bleeding according to whether rivaroxaban is administered in the morning or evening
Time frame: 3 month
Duration of hospitalization
Time frame: 3 month
Safety and efficacy of rivaroxaban administration via tube or by crush tablet
Time frame: 3 month
Definite clinical data on patients developing recurrent ischemic stroke or intracranial hemorrhage during rivaroxaban medication
Time frame: 3 month
Medical expenditures using a model
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2014.
- Derived from this study: PubMed 35385480Koge 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.
- Derived from this study: PubMed 26987488Yasaka 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kazuo Minematsu, M.D. principal investigator
Japan Cardiovascular Research Foundation, and National Cerebral and Cardiovascular Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Acute and Atrial Fibrillation, run by Japan Cardiovascular Research Foundation at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Satoko Matsumoto (+81-6-6872-0010, relaxed@jcvrf.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent ischemic stroke and major bleeding (time frame: 3 monhths). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02129920, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2014.