StrokeNEURO-XARNCT01925755
Non-interventional Local Study on Prescription Behavior of Anticoagulation Therapy in Secondary Stroke Prevention in Atrial Fibrillation Patients
An observational study of Stroke and Embolism, run by Bayer at 1 site in Russia.
Trial summary
This is local prospective multicenter observational non-interventional local study. Primary study objective is investigate and describe prescription pattern of neurologists in secondary stroke or non-CNS (non-Central Nervous System) systemic embolism prevention in patients with AF (Atrial fibrillation) and prior… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Rivaroxaban ( Xarelto, BAY59-7939)
- Type of treatment
- Pill or oral medicine
- How many people
- 209 participants
- Where
- 1 siteRussia
- Study dates
- Jul 2013to Jul 2015
- 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: Male and female patients ≥ 18 years old with prior stroke or TIA history and who have never taken anticoagulation treatment regarding AF before and meet criteria of inclusion and exclusion.
Who may be able to join
- Male and female patients ≥ 18 years old who start treatment with rivaroxaban
- Non-valvular Atrial Fibrillation is documented in patients' file
- Prior TIA/Stroke history
- TIA - more than 72 hours after documented TIA
- more than 2 weeks after non-hemorrhagic stroke
- Written informed consent
Who cannot join
- Contraindications for use of Xarelto® in accordance with approved product label
- Previous thromboprophylaxis treatment with anticoagulants prior toby reason of stroke / TIA prevention
- Any reasons of medical and non-medical character, which in the opinion of the physician can hamper patient participation in NIS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Multicenter Observational Non-interventional Local Study on Prescription Behavior of Anticoagulation Therapy in Secondary Stroke Prevention in Atrial Fibrillation Patients
This is local prospective multicenter observational non-interventional local study. Primary study objective is investigate and describe prescription pattern of neurologists in secondary stroke or non-CNS (non-Central Nervous System) systemic embolism prevention in patients with AF (Atrial fibrillation) and prior stroke or TIA (Transient Ischemic attack) who treat with rivaroxaban at an initial visit and three follow-up visits.
- Being tested
- Rivaroxaban ( Xarelto, BAY59-7939)
- Keywords
- Non-interventional, Rivaroxaban, Prevention in prior stroke or TIA, Russian Federation
- Medical subject headings
- Stroke, Embolism, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban ( Xarelto, BAY59-7939)Other
Patients with prior stroke or TIA history and who have never taken anticoagulation treatment regarding AF before. One film-coated tablet contains Rivaroxaban 15 mg or 20mg
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Other: Rivaroxaban ( Xarelto, BAY59-7939) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prescription pattern of neurologists in secondary stroke or non-CNS systemic embolism prevention in patients with AF and prior stroke or TIA who treat with rivaroxaban
- Time lag after prior stroke or TIA before Xarelto prescription;
- Frequency of switching/discontinuation of Xarelto treatment;
- Time to switching/discontinuation of Xarelto treatment;
- Reasons of switching/discontinuation of Xarelto treatment (using formalized criteria list);
- In case of change of treatment - drug, dose, duration of use
Measured: up to 6 months
Secondary outcomes (3)
Descriptive characteristics of patients after prior stroke/TIA in the need of secondary stroke prevention with Xarelto (gender, age, race, alcohol/smoking, BMI and BP abnormalities, CHA2DS2 VASC, HAS BLED, Rankin Score)
CHA2DS2 VASC - Stroke risk assessment scale; HAS BLED - Score for Major Bleeding Risk (in anticoagulation therapy)
Measured: up to 6 months
Identify time of start of anticoagulation therapy immediately after event (stroke or TIA) for secondary prevention in real life practice
Measured: up to 6 months
Describe AE characteristics (frequency, severity, relation to treatment, AE treatment, AE outcome)
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 posted20 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionJan 2015
- Study completionJul 2015
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 209 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
- NCT01925755
- Sponsor's protocol ID
- 16627
- Other IDs
- XA2012-01RU
- Acronym
- NEURO-XAR
- Status last verified
- Jan 2017
- First submitted
- 15 Jul 2013
- Last updated
- 23 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Observational Non-interventional Local Study on Prescription Behavior of Anticoagulation Therapy in Secondary Stroke Prevention in Atrial Fibrillation Patients
- ClinicalTrials.gov ID
- NCT01925755
- Acronym / sponsor ID
- NEURO-XAR / 16627
- Keywords
- Non-interventional, Rivaroxaban, Prevention in prior stroke or TIA, Russian Federation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Study start
- Jul 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 20 Aug 2013 (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 is local prospective multicenter observational non-interventional local study. Primary study objective is investigate and describe prescription pattern of neurologists in secondary stroke or non-CNS (non-Central Nervous System) systemic embolism prevention in patients with AF (Atrial fibrillation) and prior stroke or TIA (Transient Ischemic attack) who treat with rivaroxaban at an initial visit and three follow-up visits.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Rivaroxaban ( Xarelto, BAY59-7939) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female patients ≥ 18 years old with prior stroke or TIA history and who have never taken anticoagulation treatment regarding AF before and meet criteria of inclusion and exclusion.
Key inclusion criteria (6 listed)
- Male and female patients ≥ 18 years old who start treatment with rivaroxaban
- Non-valvular Atrial Fibrillation is documented in patients' file
- Prior TIA/Stroke history
- TIA - more than 72 hours after documented TIA
- more than 2 weeks after non-hemorrhagic stroke
Key exclusion criteria (3 listed)
- Contraindications for use of Xarelto® in accordance with approved product label
- Previous thromboprophylaxis treatment with anticoagulants prior toby reason of stroke / TIA prevention
- Any reasons of medical and non-medical character, which in the opinion of the physician can hamper patient participation in NIS
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 with prior stroke or TIA history and who have never taken anticoagulation treatment regarding AF before. One film-coated tablet contains Rivaroxaban 15 mg or 20mg | Other | Group 1 |
Primary outcome
Prescription pattern of neurologists in secondary stroke or non-CNS systemic embolism prevention in patients with AF and prior stroke or TIA who treat with rivaroxaban
Time frame: up to 6 months
* Time lag after prior stroke or TIA before Xarelto prescription; * Frequency of switching/discontinuation of Xarelto treatment; * Time to switching/discontinuation of Xarelto treatment; * Reasons of switching/discontinuation of Xarelto treatment (using formalized criteria list); * In case of change of treatment - drug, dose, duration of use
3 secondary outcomes
Descriptive characteristics of patients after prior stroke/TIA in the need of secondary stroke prevention with Xarelto (gender, age, race, alcohol/smoking, BMI and BP abnormalities, CHA2DS2 VASC, HAS BLED, Rankin Score)
Time frame: up to 6 months
Identify time of start of anticoagulation therapy immediately after event (stroke or TIA) for secondary prevention in real life practice
Time frame: up to 6 months
Describe AE characteristics (frequency, severity, relation to treatment, AE treatment, AE outcome)
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 23 Jan 2017.
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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 and Embolism, run by Bayer at 1 site in Russia.
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 3 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 23 Jan 2017. 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 Russia. 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?
Prescription pattern of neurologists in secondary stroke or non-CNS systemic embolism prevention in patients with AF and prior stroke or TIA who treat with rivaroxaban (time frame: up to 6 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 23 Jan 2017.