Non-valvular Atrial FibrillationEXPANDNCT02147444
Evaluation of Effectiveness and Safety of Xa Inhibitor for the Prevention of Stroke And Systemic Embolism in a Nationwide Cohort of Japanese Patients Diagnosed as Non-valvular Atrial Fibrillation
An observational study of Non-valvular Atrial Fibrillation, run by Tohoku University at 1 site in Japan.
Trial summary
The efficacy and safety of a novel oral Xa inhibitor for stroke and systemic embolism, namely rivaroxaban, in non-valvular atrial fibrillation patients are evaluated in Japanese clinical practice. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Non-valvular Atrial Fibrillation
- How many people
- 7,000 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2012to Jun 2016
- How long will I take part?
- 2 Years
- 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: Non-valvular atrial fibrillation (In the present study, non-valvular atrial fibrillation refers to atrial fibrillation without a history of prosthetic valve replacement or mitral valve stenosis.)
Who may be able to join
- Patients who meet all the criteria below
- Patients aged over 20 years
- Patients diagnosed with non-valvular atrial fibrillation
- Patients who are treated or will be treated with rivaroxaban
- Patients from whom written informed consent has been obtained
Who cannot join
- Patients who meet any of the criteria below
- The following patients in whom rivaroxaban is contraindicated for use
- Patients with a history of allergies to the ingredients contained in this drug
- Patients having a hemorrhagic event (intracranial hemorrhage, gastrointestinal hemorrhage or other clinically significant hemorrhagic events)
- Patients having liver disease complicated with coagulation disorder or those having moderate or worse liver disorder (Grade B or C in accordance with the Child-Pugh classification)
- Patients having renal failure (creatinine clearance: <15 mL/min)
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- Women who are or are likely to be pregnant
- Patients who are treated with HIV protease inhibitors (including ritonavir, atazanavir and indinavir)
- Patients who are treated with oral or injectable formulations of azole antifungal drugs (including itraconazole, voriconazole and ketoconazole (excluding fluconazole))
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine
Sendai, Miyagi, 980-6574
Koji Fukuda, MD, PhD, +81-22-717-7153, fukuda@cardio.med.tohoku.ac.jp
Hiroaki Shimokawa, MD, PhD
About this study
Official title: Multi-center, Prospective, Non-interventional, Observational Cohort Study to Investigate Effectiveness and Safety of Rivaroxaban on Prevention of Stroke and Systemic Embolism in Patients With Non-valvular Atrial Fibrillation in Japanese Clinical Practice
The efficacy and safety of a novel oral Xa inhibitor for stroke and systemic embolism, namely rivaroxaban, in non-valvular atrial fibrillation patients are evaluated in Japanese clinical practice.
- Conditions
- Non-valvular Atrial Fibrillation
- Keywords
- Rivaroxaban, Non-valvular atrial fibrillation, NOAC, Xa inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-valvular atrial fibrillation | * Patients diagnosed with non-valvular atrial fibrillation * Patients who are treated or will be treated with rivaroxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combinations of symptomatic stroke (ischemic or hemorrhagic) and systemic embolism
Primary efficacy endpoint
Measured: up to March/2016
Clinically significant hemorrhagic events (massive hemorrhage in accordance with the ISTH classification)
Primary safety endpoint
Measured: up to March/2016
Secondary outcomes (11)
Combinations of symptomatic stroke (ischemic or hemorrhagic), systemic embolism, myocardial infarction and cardiovascular death
Secondary efficacy endpoints
Measured: up to March/2016
Symptomatic ischemic stroke
Secondary efficacy endpoints
Measured: up to March/2016
Symptomatic hemorrhagic stroke
Secondary efficacy endpoints
Measured: up to March/2016
Systemic embolism
Secondary efficacy endpoints
Measured: up to March/2016
Acute myocardial infarction/unstable angina pectoris
Secondary efficacy endpoints
Measured: up to March/2016
Cardiovascular death
Secondary efficacy endpoints
Measured: up to March/2016
Deep vein thrombosis/pulmonary thromboembolism
Secondary efficacy endpoints
Measured: up to March/2016
Transient ischemic attack
Secondary efficacy endpoints
Measured: up to March/2016
Interventional/surgical treatment
Secondary efficacy endpoints
Measured: up to March/2016
All-cause death
Secondary efficacy endpoints
Measured: up to March/2016
Clinically insignificant hemorrhagic events (hemorrhagic events other than clinically significant hemorrhagic events)
Secondary safety endpoint
Measured: up to March/2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2014 (estimated)
- Study startNov 2012
- Primary completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-valvular Atrial FibrillationStudies 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
- 7,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Tohoku University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hiroaki Shimokawa, MD, PhD, Tohoku University
- Investigators
- Hiroaki Shimokawa, MD, PhD, Study chair, Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02147444
- Sponsor's protocol ID
- EXPAND study
- Other IDs
- UMIN000009376
- Acronym
- EXPAND
- Status last verified
- May 2014
- First submitted
- 12 May 2014
- Last updated
- 26 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shimizu W, Uchiyama S, Atarashi H, Inoue H, Kitazono T, Yamashita T, Ikeda T, Kamouchi M, Kaikita K, Fukuda K, Origasa H, Shimokawa H. Effectiveness and safety of reduced-dose rivaroxaban for elderly patients with non-valvular atrial fibrillation: A subanalysis of the EXPAND study. Int J Cardiol. 2023 Nov 15;391:131290. doi: 10.1016/j.ijcard.2023.131290. Epub 2023 Aug 22.
PubMed 37619876
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Prospective, Non-interventional, Observational Cohort Study to Investigate Effectiveness and Safety of Rivaroxaban on Prevention of Stroke and Systemic Embolism in Patients With Non-valvular Atrial Fibrillation in Japanese Clinical Practice
- ClinicalTrials.gov ID
- NCT02147444
- Acronym / sponsor ID
- EXPAND / EXPAND study
- Conditions
- Non-valvular Atrial Fibrillation
- Keywords
- Rivaroxaban, Non-valvular atrial fibrillation, NOAC, Xa inhibitor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- Tohoku UniversityUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jun 2016 (estimated)
- First posted
- 26 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.
The efficacy and safety of a novel oral Xa inhibitor for stroke and systemic embolism, namely rivaroxaban, in non-valvular atrial fibrillation patients are evaluated in Japanese clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-valvular atrial fibrillation | – | –* Patients diagnosed with non-valvular atrial fibrillation * Patients who are treated or will be treated with rivaroxaban |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non-valvular atrial fibrillation (In the present study, non-valvular atrial fibrillation refers to atrial fibrillation without a history of prosthetic valve replacement or mitral valve stenosis.)
Key inclusion criteria (5 listed)
- Patients who meet all the criteria below
- Patients aged over 20 years
- Patients diagnosed with non-valvular atrial fibrillation
- Patients who are treated or will be treated with rivaroxaban
- Patients from whom written informed consent has been obtained
Key exclusion criteria (9 listed)
- Patients who meet any of the criteria below
- The following patients in whom rivaroxaban is contraindicated for use
- Patients with a history of allergies to the ingredients contained in this drug
- Patients having a hemorrhagic event (intracranial hemorrhage, gastrointestinal hemorrhage or other clinically significant hemorrhagic events)
- Patients having liver disease complicated with coagulation disorder or those having moderate or worse liver disorder (Grade B or C in accordance with the Child-Pugh classification)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Combinations of symptomatic stroke (ischemic or hemorrhagic) and systemic embolism
Time frame: up to March/2016
Primary efficacy endpoint
Clinically significant hemorrhagic events (massive hemorrhage in accordance with the ISTH classification)
Time frame: up to March/2016
Primary safety endpoint
11 secondary outcomes
Combinations of symptomatic stroke (ischemic or hemorrhagic), systemic embolism, myocardial infarction and cardiovascular death
Time frame: up to March/2016
Symptomatic ischemic stroke
Time frame: up to March/2016
Symptomatic hemorrhagic stroke
Time frame: up to March/2016
Systemic embolism
Time frame: up to March/2016
Acute myocardial infarction/unstable angina pectoris
Time frame: up to March/2016
Cardiovascular death
Time frame: up to March/2016
Deep vein thrombosis/pulmonary thromboembolism
Time frame: up to March/2016
Transient ischemic attack
Time frame: up to March/2016
Interventional/surgical treatment
Time frame: up to March/2016
All-cause death
Time frame: up to March/2016
Clinically insignificant hemorrhagic events (hemorrhagic events other than clinically significant hemorrhagic events)
Time frame: up to March/2016
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2014.
- Derived from this study: PubMed 37619876Shimizu W, Uchiyama S, Atarashi H, Inoue H, Kitazono T, Yamashita T, Ikeda T, Kamouchi M, Kaikita K, Fukuda K, Origasa H, Shimokawa H. Effectiveness and safety of reduced-dose rivaroxaban for elderly patients with non-valvular atrial fibrillation: A subanalysis of the EXPAND study. Int J Cardiol. 2023 Nov 15;391:131290. doi: 10.1016/j.ijcard.2023.131290. Epub 2023 Aug 22.
- EXPAND study home pageLink provided by the sponsor.
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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.
Hiroaki Shimokawa, MD, PhD study chair
Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine
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 Non-valvular Atrial Fibrillation, run by Tohoku University 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 5 inclusion and 9 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 26 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 Koji Fukuda, M.D., Ph. D (+81-22-717-7153, fukuda@cardio.med.tohoku.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combinations of symptomatic stroke (ischemic or hemorrhagic) and systemic embolism (time frame: up to March/2016). The study lists 2 primary outcomes in all. 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 NCT02147444, which also lists 1 linked publication.
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 26 May 2014.