AnticoagulationNCT01907048
Patient and Physician Knowledge of Key Safety Messages
An observational study of Anticoagulation, run by Bayer at 4 sites in 4 countries.
Trial summary
This cross-sectional epidemiologic study measured physician and patient awareness and understanding of the key messages in the Xarelto prescriber guide and Xarelto patient alert card. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anticoagulation
- What is being tested?
- Rivaroxaban (Xarelto, BAY59-7939)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,227 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 15 Sep 2014to 15 Apr 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Physicians of various specialties; patients treated in primary care and specilized clinical practices.
- Inclusion criteria:
Physician eligibility:
- Prescription of rivaroxaban in the past 6 months for adult patients for the Prevention of stroke and systemic embolism with non-valvular atrial fibrillation (SPAF) or Treatment of deep venous thrombosis (DVT) and prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT.
Patient eligibility:
- Use of rivaroxaban for SPAF or DVT within the previous 3 months; aged 18 years and above; able to understand and complete the consent form and patient questionnaire.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: Xarelto (Rivaroxaban) Risk Minimisation Plan Evaluation: Patient and Physician Knowledge of Key Safety Messages
This cross-sectional epidemiologic study measured physician and patient awareness and understanding of the key messages in the Xarelto prescriber guide and Xarelto patient alert card.
- Conditions
- Anticoagulation
- Being tested
- Rivaroxaban (Xarelto, BAY59-7939)
- Keywords
- Survey, Effectiveness of risk minimization measures, Rivaroxaban, Anticoagulants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban (Xarelto, BAY59-7939)Behavioural
Survey to measure physician awareness and understanding of the key messages in the prescriber guide.
Rivaroxaban (Xarelto, BAY59-7939)Behavioural
Survey to measure patient awareness and understanding of the key messages in the patient card.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Survey to measure physician awareness and understanding of the key messages in the prescriber guide. Receives: Behavioral: Rivaroxaban (Xarelto, BAY59-7939) | |
| Group 2 | Survey to measure patient awareness and understanding of the key messages in the patient card. Receives: Behavioral: Rivaroxaban (Xarelto, BAY59-7939) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge and understanding among physicians regarding key safety information contained in the prescriber guide assessed by web-based questionnaire
Measured: Up to 18 months
Knowledge and understanding of patients regarding the key safety information contained in the patient alert card assessed by paper-based questionnaire
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study start15 Sep 2014
- Primary completion21 Feb 2020
- Study completion15 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnticoagulationStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 2,227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC, RTI Health Solutions
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01907048
- Sponsor's protocol ID
- 16167
- Other IDs
- XA1202
- Status last verified
- Apr 2021
- First submitted
- 12 Jun 2013
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xarelto (Rivaroxaban) Risk Minimisation Plan Evaluation: Patient and Physician Knowledge of Key Safety Messages
- ClinicalTrials.gov ID
- NCT01907048
- Acronym / sponsor ID
- 16167
- Conditions
- Anticoagulation
- Keywords
- Survey, Effectiveness of risk minimization measures, Rivaroxaban, Anticoagulants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,227 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC, RTI Health Solutions
- Study start
- 15 Sep 2014 (actual)
- Primary completion
- 21 Feb 2020 (actual)
- Study completion
- 15 Apr 2020 (actual)
- First posted
- 24 Jul 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 cross-sectional epidemiologic study measured physician and patient awareness and understanding of the key messages in the Xarelto prescriber guide and Xarelto patient alert card.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Behavioral: Rivaroxaban (Xarelto, BAY59-7939)Survey to measure physician awareness and understanding of the key messages in the prescriber guide. |
| Group 2 | – | Behavioral: Rivaroxaban (Xarelto, BAY59-7939)Survey to measure patient awareness and understanding of the key messages in the patient card. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Physicians of various specialties; patients treated in primary care and specilized clinical practices.
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)Survey to measure physician awareness and understanding of the key messages in the prescriber guide. | Behavioural | Group 1 |
| Rivaroxaban (Xarelto, BAY59-7939)Survey to measure patient awareness and understanding of the key messages in the patient card. | Behavioural | Group 2 |
Primary outcome
Knowledge and understanding among physicians regarding key safety information contained in the prescriber guide assessed by web-based questionnaire
Time frame: Up to 18 months
Knowledge and understanding of patients regarding the key safety information contained in the patient alert card assessed by paper-based questionnaire
Time frame: Up to 18 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 8 Apr 2021.
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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
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anticoagulation, run by Bayer at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Germany, Spain, United Kingdom. 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?
Knowledge and understanding among physicians regarding key safety information contained in the prescriber guide assessed by web-based questionnaire (time frame: Up to 18 months). 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?
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 8 Apr 2021.