StrokeXASSURENCT02784717
Xarelto on Prevention of Stroke and Non-central Nervous System Systemic Embolism in Patients With Non-valvular Atrial Fibrillation in China: A Non-interventional Study
An observational study of Stroke, run by Bayer at 1 site in China.
Trial summary
This non-interventional field study will investigate rivaroxaban under clinical practice conditions for stroke prevention and for prevention of non-CNS systemic embolism in patients with non-valvular atrial fibrillation in China. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Rivaroxaban (Xarelto, BAY 59-7939)
- How many people
- 3,055 participants
- Where
- 1 siteChina
- Study dates
- 11 May 2016to 24 Sep 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Female and male patients, who are at least 18 years of age with a diagnosis of non-valvular atrial fibrillation will be enrolled after the decision for a pharmacologic prophylaxis with rivaroxaban within approved indication to prevent stroke or non-CNS systemic embolism has been made.
Who may be able to join
- Female and male patients ≥ 18 years of age diagnosed with non-valvular atrial fibrillation
- Patients for whom the decision to initiate treatment with rivaroxaban to prevent stroke or non-CNS systemic embolism was made as per investigator's routine treatment practice
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Xarelto® on Prevention of Stroke and Non-central Nervous System Systemic Embolism in Patients With Non-valvular Atrial Fibrillation in China: A Non-interventional Study
This non-interventional field study will investigate rivaroxaban under clinical practice conditions for stroke prevention and for prevention of non-CNS systemic embolism in patients with non-valvular atrial fibrillation in China.
Read the detailed description
3000 patients will be provided with free drug.It is planned to have an interim analysis(IA) when 3000 patients are enrolled (cut off day is the 3000th patient completed at least 3 months follow-up visit). To end or continue enrolling patients will be decided based on the IA result and the evaluation comments from CFDA.
- Conditions
- Stroke
- Being tested
- Rivaroxaban (Xarelto, BAY 59-7939)
- Keywords
- rivaroxaban,, non-interventional,, atrial fibrillation,, stroke prevention,
- Medical subject headings
- Stroke, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban (Xarelto, BAY 59-7939)Drug
Decision regarding dose and duration of treatment made at the discretion of the attending investigator.
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban (Xarelto, BAY 59-7939) | Female and male patients, who are at least 18 years of age with a diagnosis of non-valvular atrial fibrillation will be enrolled after the decision for a pharmacologic prophylaxis with rivaroxaban to prevent stroke or non-CNS systemic embolism has been made. Receives: Drug: Rivaroxaban (Xarelto, BAY 59-7939) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Major bleeding events
Major bleeding events, collected as serious or non serious adverse events and defined as overt bleeding associated with:
- a fall in haemoglobin of ≥2 g/dL, or
- a transfusion of ≥2 units of packed red blood cells or whole blood, or
- occurrence at a critical site (intracranial, intra-spinal, intraocular, pericardial, intra articular, intra-muscular with compartment syndrome, retroperitoneal), or
- death
Measured: Up to 30 months
Secondary outcomes (5)
Number of Symptomatic thromboembolic events
Collected as serious or non-serious adverse events
Measured: Up to 30 months
Number of Non-major bleeding
Collected as serious or non-serious adverse events and defined as all bleeding events that do not fall in the category of major bleedings
Measured: Up to 30 months
Treatment satisfaction questionnaire
Measured: Up to 30 months
Adverse event and serious adverse event percentage in the different atrial fibrillation risk factor categories
Measured: Up to 30 months
Number of each reason for any switch from or interruption of rivaroxaban treatment
If the patients switch from or interruption of rivaroxaban treatment, patients or physicians will be asked by several questions about the reasons of the switch and interruption, and collected in CRF. The reasons will be described by frequency distributions.
Reason choice as below:
- Patient choice 2. Insufficient therapeutic effect 3. Adverse event 4. Surgery 5. Dentistry 6. Renal function change
Measured: Up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study start11 May 2016
- Primary completion21 Feb 2019
- Study completion24 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- 3,055 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
- NCT02784717
- Sponsor's protocol ID
- 16819
- Other IDs
- XA1207CN
- Acronym
- XASSURE
- Status last verified
- Aug 2020
- First submitted
- 27 Apr 2016
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xarelto® on Prevention of Stroke and Non-central Nervous System Systemic Embolism in Patients With Non-valvular Atrial Fibrillation in China: A Non-interventional Study
- ClinicalTrials.gov ID
- NCT02784717
- Acronym / sponsor ID
- XASSURE / 16819
- Conditions
- Stroke
- Keywords
- rivaroxaban,, non-interventional,, atrial fibrillation,, stroke prevention,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,055 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Scientific Affairs, LLC
- Study start
- 11 May 2016 (actual)
- Primary completion
- 21 Feb 2019 (actual)
- Study completion
- 24 Sep 2019 (actual)
- First posted
- 27 May 2016 (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 non-interventional field study will investigate rivaroxaban under clinical practice conditions for stroke prevention and for prevention of non-CNS systemic embolism in patients with non-valvular atrial fibrillation in China.
Detailed description
3000 patients will be provided with free drug.It is planned to have an interim analysis(IA) when 3000 patients are enrolled (cut off day is the 3000th patient completed at least 3 months follow-up visit). To end or continue enrolling patients will be decided based on the IA result and the evaluation comments from CFDA.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban (Xarelto, BAY 59-7939) | – | Drug: Rivaroxaban (Xarelto, BAY 59-7939)Female and male patients, who are at least 18 years of age with a diagnosis of non-valvular atrial fibrillation will be enrolled after the decision for a pharmacologic prophylaxis with rivaroxaban to prevent stroke or non-CNS systemic embolism has been made. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female and male patients, who are at least 18 years of age with a diagnosis of non-valvular atrial fibrillation will be enrolled after the decision for a pharmacologic prophylaxis with rivaroxaban within approved indication to prevent stroke or non-CNS systemic embolism has been made.
Key inclusion criteria (2 listed)
- Female and male patients ≥ 18 years of age diagnosed with non-valvular atrial fibrillation
- Patients for whom the decision to initiate treatment with rivaroxaban to prevent stroke or non-CNS systemic embolism was made as per investigator's routine treatment practice
Key exclusion criteria (1 listed)
- NA
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, BAY 59-7939)Decision regarding dose and duration of treatment made at the discretion of the attending investigator. | Drug | Rivaroxaban (Xarelto, BAY 59-7939) |
Primary outcome
Number of Major bleeding events
Time frame: Up to 30 months
Major bleeding events, collected as serious or non serious adverse events and defined as overt bleeding associated with: 1. a fall in haemoglobin of ≥2 g/dL, or 2. a transfusion of ≥2 units of packed red blood cells or whole blood, or 3. occurrence at a critical site (intracranial, intra-spinal, intraocular, pericardial, intra articular, intra-muscular with compartment syndrome, retroperitoneal), or 4. death
5 secondary outcomes
Number of Symptomatic thromboembolic events
Time frame: Up to 30 months
Number of Non-major bleeding
Time frame: Up to 30 months
Treatment satisfaction questionnaire
Time frame: Up to 30 months
Adverse event and serious adverse event percentage in the different atrial fibrillation risk factor categories
Time frame: Up to 30 months
Number of each reason for any switch from or interruption of rivaroxaban treatment
Time frame: Up to 30 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 3 Sep 2020.
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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 Stroke, run by Bayer at 1 site in China.
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 3 Sep 2020. 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 China. 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?
Number of Major bleeding events (time frame: Up to 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Sep 2020.