Brain IschemiaNCT01582737
Xarelto [SPAF] Post-marketing Surveillance in Japan
An observational study of Brain Ischemia, run by Bayer at 1 site in Japan.
Trial summary
This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Xarelto for SPAF. The objective of this study is to assess safety and effectiveness of Xarelto using in real clinical practice. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Brain Ischemia
- What is being tested?
- Rivaroxaban(Xarelto, BAY59-7939)
- How many people
- 11,310 participants
- Where
- 1 siteJapan
- Study dates
- 30 May 2012to 17 Jan 2020
- 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with non-valvular arterial fibrillation necessary for the treatment for prevention of ischemic stroke and systemic embolism
Who may be able to join
- Patients with non-valvular atrial fibrillation (NVAF) for whom the decision to be treated with Xarelto was made
- Patients without experience of using Xarelto prior to the study
Who cannot join
- Patients who are contraindicated based on the product label
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Special Drug Use Investigation of Xarelto [SPAF]
This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Xarelto for SPAF.
The objective of this study is to assess safety and effectiveness of Xarelto using in real clinical practice.
A total of 10,000 patients are to be enrolled and assessed in 2 years standard observational period. An annual follow-up survey will be conducted for 5 years at the longest after standard observational period.
- Conditions
- Brain Ischemia
- Being tested
- Rivaroxaban(Xarelto, BAY59-7939)
- Keywords
- Xarelto, SPAF
- Medical subject headings
- Brain Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban(Xarelto, BAY59-7939)Drug
Patients treated with Xarelto under practical manner
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients treated with Xarelto for the purpose of prevention of ischemic stroke and systemic embolism Receives: Drug: Rivaroxaban(Xarelto, BAY59-7939) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ADRs and serious AEs (especially for hemorrhagic events, and liver disfunction with increase of liver-function-relating enzymes including bilirubin)
Measured: Up to 2 years
Incidence of events of stroke
Measured: Up to 5 years
Incidence of events of non-central nervous system embolism
Measured: Up to 5 years
Secondary outcomes (3)
Determination of patient's demography to affect the safety and efficacy of Xarelto using standard observational survey and follow-up survey
Measured: Baseline
Determination of patient's medical history to affect the safety and efficacy of Xarelto using standard observational survey and follow-up survey
Measured: Baseline
Determination of patient's background to affect the safety and efficacy of Xarelto using standard observational survey and follow-up survey
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2012 (estimated)
- Study start30 May 2012
- Primary completion31 Mar 2019
- Study completion17 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Brain IschemiaStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 11,310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01582737
- Sponsor's protocol ID
- 15798
- Other IDs
- XAR-SPAF
- Status last verified
- Jul 2023
- First submitted
- 20 Apr 2012
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Minematsu K, Ikeda T, Ogawa S, Kitazono T, Nakagawara J, Miyamoto S, Murakawa Y, Takeichi M, Kidani Y, Okayama Y, Sunaya T, Sato S, Yamanaka S. Real-World Outcomes of Rivaroxaban Treatment in Patients with Both Nonvalvular Atrial Fibrillation and a History of Ischemic Stroke/Transient Ischemic Attack. Cerebrovasc Dis. 2019;48(1-2):53-60. doi: 10.1159/000502883. Epub 2019 Oct 2.
PubMed 31578012Ikeda T, Ogawa S, Kitazono T, Nakagawara J, Minematsu K, Miyamoto S, Murakawa Y, Iwashiro S, Kidani Y, Okayama Y, Sunaya T, Sato S, Yamanaka S. Outcomes associated with under-dosing of rivaroxaban for management of non-valvular atrial fibrillation in real-world Japanese clinical settings. J Thromb Thrombolysis. 2019 Nov;48(4):653-660. doi: 10.1007/s11239-019-01934-6.
PubMed 31432451Nakagawara J, Ikeda T, Ogawa S, Kitazono T, Minematsu K, Miyamoto S, Murakawa Y, Takeichi M, Kidani Y, Okayama Y, Sunaya T, Sato S, Yamanaka S. Real-world outcomes of rivaroxaban treatment in patients with nonvalvular atrial fibrillation and worsening renal function. J Cardiol. 2019 Dec;74(6):501-506. doi: 10.1016/j.jjcc.2019.06.003. Epub 2019 Jul 29.
PubMed 31371191Ikeda T, Ogawa S, Kitazono T, Nakagawara J, Minematsu K, Miyamoto S, Murakawa Y, Takeichi M, Ohashi Y, Okayama Y, Sunaya T, Yamanaka S. Real-world outcomes of the Xarelto Post-Authorization Safety & Effectiveness Study in Japanese Patients with Atrial Fibrillation (XAPASS). J Cardiol. 2019 Jul;74(1):60-66. doi: 10.1016/j.jjcc.2019.01.001. Epub 2019 Feb 8.
PubMed 30745002Ogawa S, Minematsu K, Ikeda T, Kitazono T, Nakagawara J, Miyamoto S, Murakawa Y, Ohashi Y, Takeichi M, Okayama Y, Yamanaka S, Inuyama L. Design and baseline characteristics of the Xarelto Post-Authorization Safety & Effectiveness Study in Japanese Patients with Atrial Fibrillation (XAPASS). J Arrhythm. 2018 Feb 7;34(2):167-175. doi: 10.1002/joa3.12034. eCollection 2018 Apr.
PubMed 29657592
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Drug Use Investigation of Xarelto [SPAF]
- ClinicalTrials.gov ID
- NCT01582737
- Acronym / sponsor ID
- 15798
- Conditions
- Brain Ischemia
- Keywords
- Xarelto, SPAF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11,310 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Study start
- 30 May 2012 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 17 Jan 2020 (actual)
- First posted
- 23 Apr 2012 (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.
This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Xarelto for SPAF.
The objective of this study is to assess safety and effectiveness of Xarelto using in real clinical practice.
A total of 10,000 patients are to be enrolled and assessed in 2 years standard observational period. An annual follow-up survey will be conducted for 5 years at the longest after standard observational period.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Rivaroxaban(Xarelto, BAY59-7939)Patients treated with Xarelto for the purpose of prevention of ischemic stroke and systemic embolism |
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with non-valvular arterial fibrillation necessary for the treatment for prevention of ischemic stroke and systemic embolism
Key inclusion criteria (2 listed)
- Patients with non-valvular atrial fibrillation (NVAF) for whom the decision to be treated with Xarelto was made
- Patients without experience of using Xarelto prior to the study
Key exclusion criteria (1 listed)
- Patients who are contraindicated based on the product label
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 |
|---|---|---|
| Rivaroxaban(Xarelto, BAY59-7939)Patients treated with Xarelto under practical manner | Drug | Group 1 |
Primary outcome
Incidence of ADRs and serious AEs (especially for hemorrhagic events, and liver disfunction with increase of liver-function-relating enzymes including bilirubin)
Time frame: Up to 2 years
Incidence of events of stroke
Time frame: Up to 5 years
Incidence of events of non-central nervous system embolism
Time frame: Up to 5 years
3 secondary outcomes
Determination of patient's demography to affect the safety and efficacy of Xarelto using standard observational survey and follow-up survey
Time frame: Baseline
Determination of patient's medical history to affect the safety and efficacy of Xarelto using standard observational survey and follow-up survey
Time frame: Baseline
Determination of patient's background to affect the safety and efficacy of Xarelto using standard observational survey and follow-up survey
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Derived from this study: PubMed 31578012Minematsu K, Ikeda T, Ogawa S, Kitazono T, Nakagawara J, Miyamoto S, Murakawa Y, Takeichi M, Kidani Y, Okayama Y, Sunaya T, Sato S, Yamanaka S. Real-World Outcomes of Rivaroxaban Treatment in Patients with Both Nonvalvular Atrial Fibrillation and a History of Ischemic Stroke/Transient Ischemic Attack. Cerebrovasc Dis. 2019;48(1-2):53-60. doi: 10.1159/000502883. Epub 2019 Oct 2.
- Derived from this study: PubMed 31432451Ikeda T, Ogawa S, Kitazono T, Nakagawara J, Minematsu K, Miyamoto S, Murakawa Y, Iwashiro S, Kidani Y, Okayama Y, Sunaya T, Sato S, Yamanaka S. Outcomes associated with under-dosing of rivaroxaban for management of non-valvular atrial fibrillation in real-world Japanese clinical settings. J Thromb Thrombolysis. 2019 Nov;48(4):653-660. doi: 10.1007/s11239-019-01934-6.
- Derived from this study: PubMed 31371191Nakagawara J, Ikeda T, Ogawa S, Kitazono T, Minematsu K, Miyamoto S, Murakawa Y, Takeichi M, Kidani Y, Okayama Y, Sunaya T, Sato S, Yamanaka S. Real-world outcomes of rivaroxaban treatment in patients with nonvalvular atrial fibrillation and worsening renal function. J Cardiol. 2019 Dec;74(6):501-506. doi: 10.1016/j.jjcc.2019.06.003. Epub 2019 Jul 29.
- Derived from this study: PubMed 30745002Ikeda T, Ogawa S, Kitazono T, Nakagawara J, Minematsu K, Miyamoto S, Murakawa Y, Takeichi M, Ohashi Y, Okayama Y, Sunaya T, Yamanaka S. Real-world outcomes of the Xarelto Post-Authorization Safety & Effectiveness Study in Japanese Patients with Atrial Fibrillation (XAPASS). J Cardiol. 2019 Jul;74(1):60-66. doi: 10.1016/j.jjcc.2019.01.001. Epub 2019 Feb 8.
- Derived from this study: PubMed 29657592Ogawa S, Minematsu K, Ikeda T, Kitazono T, Nakagawara J, Miyamoto S, Murakawa Y, Ohashi Y, Takeichi M, Okayama Y, Yamanaka S, Inuyama L. Design and baseline characteristics of the Xarelto Post-Authorization Safety & Effectiveness Study in Japanese Patients with Atrial Fibrillation (XAPASS). J Arrhythm. 2018 Feb 7;34(2):167-175. doi: 10.1002/joa3.12034. eCollection 2018 Apr.
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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.
Bayer Study Director study director
Bayer
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 Brain Ischemia, run by Bayer 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 24 Jul 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of ADRs and serious AEs (especially for hemorrhagic events, and liver disfunction with increase of liver-function-relating enzymes including bilirubin) (time frame: Up to 2 years). The study lists 3 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 NCT01582737, which also lists 5 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 24 Jul 2023.