Non-valvular Atrial Fibrillation (NVAF)NCT01598051
Xarelto [SPAF-QOL] Post-marketing Surveillance in Japan
An observational study of Non-valvular Atrial Fibrillation (NVAF), run by Bayer at 1 site in Japan.
Trial summary
The objective of this study is to understand if Rivaroxaban can improve treatment satisfaction of Warfarin patients and assess the safety and effectiveness of Xarelto in real clinical practice. A total of 725 patients are to be enrolled and followed for a 6 months.period. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Non-valvular Atrial Fibrillation (NVAF)
- What is being tested?
- Rivaroxaban (Xarelto_ BAY59-7939)
- How many people
- 741 participants
- Where
- 1 siteJapan
- Study dates
- 31 May 2012to 31 Mar 2017
- 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: Patients with non-valvular atrial fibrillation necessary for the treatment for prevention of ischemic stroke and systemic embolism
Who may be able to join
- Patients treated by Warfarin for their atrial fibrillation for at least two months at the time of the study initiation.
- Rivaroxaban naïve patients
- Patients 20 years old or older.
- Patients who agree to sign the inform consent
Who cannot join
- Patients who are contraindicated by product label
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment Satisfaction Under Rivaroxaban (ACTS/TSQM)
The objective of this study is to understand if Rivaroxaban can improve treatment satisfaction of Warfarin patients and assess the safety and effectiveness of Xarelto in real clinical practice.
A total of 725 patients are to be enrolled and followed for a 6 months.period. QOL survey will be conducted at month 0, 3, 6 using ACTS/TSQM.
This study is categorized as a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Xarelto for SPAF.
- Conditions
- Non-valvular Atrial Fibrillation (NVAF)
- Being tested
- Rivaroxaban (Xarelto_ BAY59-7939)
- Keywords
- Xarelto, SPAF, QOL
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 for SPAF.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients treated with Xarelto under practical manner for SPAF. Receives: Drug: Rivaroxaban (Xarelto_ BAY59-7939) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of treatment satisfaction (Evaluated through ACTS and TSQM questionnaires)
Measured: Up to 6 months
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 6 months
Incidence of events of stroke
Measured: Up to 6 months
Incidence of events of non-central nervous system embolism
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study start31 May 2012
- Primary completion9 Jun 2016
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Non-valvular Atrial Fibrillation (NVAF)Studies 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
- 741 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Scientific Affairs, LLC
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01598051
- Sponsor's protocol ID
- 16296
- Status last verified
- May 2019
- First submitted
- 20 Apr 2012
- Last updated
- 30 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Koretsune Y, Kumagai K, Uchiyama S, Yamashita T, Yasaka M, Watanabe-Fujinuma E, Banderas BF, Akiyama S, Okayama Y, Briere JB, Dickie G, Cano SJ. Patient-reported treatment satisfaction with rivaroxaban in Japanese non-valvular atrial fibrillation patients: an observational study. Curr Med Res Opin. 2018 Dec;34(12):2157-2164. doi: 10.1080/03007995.2018.1507315. Epub 2018 Aug 14.
PubMed 30067119Watanabe-Fujinuma E, Banderas BF, Koretsune Y, Kumagai K, Uchiyama S, Yamashita T, Yasaka M, Akiyama S, Briere JB, Dickie G, Cano SJ. Psychometric validation of anti-clot treatment scale and treatment satisfaction questionnaire for medication version II in Japanese patients with atrial fibrillation. J Med Econ. 2019 Aug;22(8):798-805. doi: 10.1080/13696998.2019.1609003. Epub 2019 May 13.
PubMed 30995146Gavrilov SG, Lebedev IS. Is the endovascular embolization of tributaries of the internal iliac veins essential in the treatment of isolated pelvic-perineal reflux? Curr Med Res Opin. 2019 Jan;35(1):27-31. doi: 10.1080/03007995.2018.1498781. Epub 2018 Jul 25.
PubMed 29985674
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Satisfaction Under Rivaroxaban (ACTS/TSQM)
- ClinicalTrials.gov ID
- NCT01598051
- Acronym / sponsor ID
- 16296
- Conditions
- Non-valvular Atrial Fibrillation (NVAF)
- Keywords
- Xarelto, SPAF, QOL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 741 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Scientific Affairs, LLC
- Study start
- 31 May 2012 (actual)
- Primary completion
- 9 Jun 2016 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 15 May 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.
The objective of this study is to understand if Rivaroxaban can improve treatment satisfaction of Warfarin patients and assess the safety and effectiveness of Xarelto in real clinical practice.
A total of 725 patients are to be enrolled and followed for a 6 months.period. QOL survey will be conducted at month 0, 3, 6 using ACTS/TSQM.
This study is categorized as a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Xarelto for SPAF.
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 under practical manner for SPAF. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with non-valvular atrial fibrillation necessary for the treatment for prevention of ischemic stroke and systemic embolism
Key inclusion criteria (4 listed)
- Patients treated by Warfarin for their atrial fibrillation for at least two months at the time of the study initiation.
- Rivaroxaban naïve patients
- Patients 20 years old or older.
- Patients who agree to sign the inform consent
Key exclusion criteria (1 listed)
- Patients who are contraindicated by 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 for SPAF. | Drug | Group 1 |
Primary outcome
Improvement of treatment satisfaction (Evaluated through ACTS and TSQM questionnaires)
Time frame: Up to 6 months
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 6 months
Incidence of events of stroke
Time frame: Up to 6 months
Incidence of events of non-central nervous system embolism
Time frame: Up to 6 months
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 30 May 2019.
- Background: PubMed 30067119Koretsune Y, Kumagai K, Uchiyama S, Yamashita T, Yasaka M, Watanabe-Fujinuma E, Banderas BF, Akiyama S, Okayama Y, Briere JB, Dickie G, Cano SJ. Patient-reported treatment satisfaction with rivaroxaban in Japanese non-valvular atrial fibrillation patients: an observational study. Curr Med Res Opin. 2018 Dec;34(12):2157-2164. doi: 10.1080/03007995.2018.1507315. Epub 2018 Aug 14.
- Derived from this study: PubMed 30995146Watanabe-Fujinuma E, Banderas BF, Koretsune Y, Kumagai K, Uchiyama S, Yamashita T, Yasaka M, Akiyama S, Briere JB, Dickie G, Cano SJ. Psychometric validation of anti-clot treatment scale and treatment satisfaction questionnaire for medication version II in Japanese patients with atrial fibrillation. J Med Econ. 2019 Aug;22(8):798-805. doi: 10.1080/13696998.2019.1609003. Epub 2019 May 13.
- Derived from this study: PubMed 29985674Gavrilov SG, Lebedev IS. Is the endovascular embolization of tributaries of the internal iliac veins essential in the treatment of isolated pelvic-perineal reflux? Curr Med Res Opin. 2019 Jan;35(1):27-31. doi: 10.1080/03007995.2018.1498781. Epub 2018 Jul 25.
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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 Non-valvular Atrial Fibrillation (NVAF), 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 4 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 30 May 2019. 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?
Improvement of treatment satisfaction (Evaluated through ACTS and TSQM questionnaires) (time frame: Up to 6 months). The study lists 4 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 NCT01598051, which also lists 3 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 30 May 2019.