Atrial FibrillationROSENCT01871194
An Observational Post-Authorization Safety Specialist Cohort Event Monitoring Study (SCEM) to Monitor the Safety and Utilization of Rivaroxaban (Xarelto®).
An observational study of Atrial Fibrillation and Deep Vein Thrombosis, run by Professor Saad Shakir at 1 site in United Kingdom.
Trial summary
This study aims to evaluate the use of rivaroxaban and its short term safety when used by patients for the new indications of prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation, treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of recurrent DVT… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Deep Vein Thrombosis, Pulmonary Embolism
- How many people
- 3,400 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2013to Sep 2017
- How long will I take part?
- 12 Weeks
- 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: Patients prescribed rivaroxaban or an alternative anticoagulant in the secondary care hospital setting in England and Wales for the prevention of stroke in patients with AF, the treatment of DVT or PE, or the prevention of recurrent DVT and PE.
Who may be able to join
- age 18 years or above after study start
- index date on or after study start
- signed, informed consent
- patients treated for DVT or PE
- patients with non-valvular AF (with one or more risk factors) treated for prevention of stroke and systemic embolism
Who cannot join
- any use of univalent direct thrombin inhibitor or direct factor Xa inhibitors
- use of anticoagulant therapy or other vitamin K antagonists recorded within one year prior to index date
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Drug Safety Research Unit
Southampton, Hampshire, SO31 1AA
About this study
Official title: An Observational Post-Authorization Safety Specialist Cohort Event Monitoring Study (SCEM) to Monitor the Safety and Utilization of Rivaroxaban (Xarelto®) for the Prevention of Stroke in Patients With Atrial Fibrillation (AF), Treatment of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE), and the Prevention of Recurrent DVT and PE in the Secondary Care Hospital Setting in England and Wales.
This study aims to evaluate the use of rivaroxaban and its short term safety when used by patients for the new indications of prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation, treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of recurrent DVT and PE. Any adult patient started by their care team on rivaroxaban or an alternative anticoagulant for the specified indications during the study period will be eligible to take part. A questionnaire will be completed by the care team of each patient at the start of treatment and again 12 weeks later. The care team will complete the questionnaires using information from the patient's medical notes, not by asking the patient directly. If a participant has an adverse event during the 12 week period, we may ask the patient's care team to fill out a further follow up questionnaire. No other examinations or tests will be performed. Patients will only be recruited to the study after the clinical decision to prescribe rivaroxaban or an alternative anticoagulant has been made, so that prescribing behaviour is not altered by the study. It is an observational, non-interventional study covering the whole of England and Wales.
- Medical subject headings
- Atrial Fibrillation, Venous Thrombosis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban | This is a non-interventional study | |
| Alternative anticoagulant therapy | This is a non-interventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incident risk of haemorrhage within gastrointestinal and urogenital organ sites (which meets the criteria for a major bleed) and all intracranial sites.
The cumulative incidence will be calculated according to the formula:
Total number of new cases during 12 week observation period x 100 / Population initially at risk
If the observed cumulative incidence from this study falls within the range expected as set by the precision limits of cumulative incidence from clinical trial data, then the null hypothesis (of no difference) will not be rejected.
Measured: During 12 weeks after initiation of treatment with rivaroxaban or alternative anticoagulant therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionJan 2016
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- 3,400 participants (actual)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- Professor Saad Shakir
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor-investigator, Professor Saad Shakir, Drug Safety Research Unit, Southampton, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01871194
- Sponsor's protocol ID
- ROSE
- Acronym
- ROSE
- Status last verified
- Jan 2018
- First submitted
- 29 May 2013
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Evans A, Davies M, Osborne V, Roy D, Shakir S. Evaluation of the incidence of bleeding in patients prescribed rivaroxaban for the treatment and prevention of deep vein thrombosis and pulmonary embolism in UK secondary care: an observational cohort study. BMJ Open. 2020 Nov 3;10(11):e038102. doi: 10.1136/bmjopen-2020-038102.
PubMed 33148732
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Post-Authorization Safety Specialist Cohort Event Monitoring Study (SCEM) to Monitor the Safety and Utilization of Rivaroxaban (Xarelto®) for the Prevention of Stroke in Patients With Atrial Fibrillation (AF), Treatment of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE), and the Prevention of Recurrent DVT and PE in the Secondary Care Hospital Setting in England and Wales.
- ClinicalTrials.gov ID
- NCT01871194
- Acronym / sponsor ID
- ROSE / ROSE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,400 participants (actual)
- Lead sponsor
- Professor Saad ShakirUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- May 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 6 Jun 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 study aims to evaluate the use of rivaroxaban and its short term safety when used by patients for the new indications of prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation, treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of recurrent DVT and PE. Any adult patient started by their care team on rivaroxaban or an alternative anticoagulant for the specified indications during the study period will be eligible to take part. A questionnaire will be completed by the care team of each patient at the start of treatment and again 12 weeks later. The care team will complete the questionnaires using information from the patient's medical notes, not by asking the patient directly. If a participant has an adverse event during the 12 week period, we may ask the patient's care team to fill out a further follow up questionnaire. No other examinations or tests will be performed. Patients will only be recruited to the study after the clinical decision to prescribe rivaroxaban or an alternative anticoagulant has been made, so that prescribing behaviour is not altered by the study. It is an observational, non-interventional study covering the whole of England and Wales.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban | – | –This is a non-interventional study |
| Alternative anticoagulant therapy | – | –This is a non-interventional study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients prescribed rivaroxaban or an alternative anticoagulant in the secondary care hospital setting in England and Wales for the prevention of stroke in patients with AF, the treatment of DVT or PE, or the prevention of recurrent DVT and PE.
Key inclusion criteria (5 listed)
- age 18 years or above after study start
- index date on or after study start
- signed, informed consent
- patients treated for DVT or PE
- patients with non-valvular AF (with one or more risk factors) treated for prevention of stroke and systemic embolism
Key exclusion criteria (2 listed)
- any use of univalent direct thrombin inhibitor or direct factor Xa inhibitors
- use of anticoagulant therapy or other vitamin K antagonists recorded within one year prior to index date
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cumulative incident risk of haemorrhage within gastrointestinal and urogenital organ sites (which meets the criteria for a major bleed) and all intracranial sites.
Time frame: During 12 weeks after initiation of treatment with rivaroxaban or alternative anticoagulant therapy
The cumulative incidence will be calculated according to the formula: Total number of new cases during 12 week observation period x 100 / Population initially at risk If the observed cumulative incidence from this study falls within the range expected as set by the precision limits of cumulative incidence from clinical trial data, then the null hypothesis (of no difference) will not be rejected.
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 Jan 2018.
- Derived from this study: PubMed 33148732Evans A, Davies M, Osborne V, Roy D, Shakir S. Evaluation of the incidence of bleeding in patients prescribed rivaroxaban for the treatment and prevention of deep vein thrombosis and pulmonary embolism in UK secondary care: an observational cohort study. BMJ Open. 2020 Nov 3;10(11):e038102. doi: 10.1136/bmjopen-2020-038102.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Atrial Fibrillation and Deep Vein Thrombosis, run by Professor Saad Shakir at 1 site in United Kingdom.
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 5 inclusion and 2 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 Jan 2018. 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 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?
Cumulative incident risk of haemorrhage within gastrointestinal and urogenital organ sites (which meets the criteria for a major bleed) and all intracranial sites. (time frame: During 12 weeks after initiation of treatment with rivaroxaban or alternative anticoagulant therapy). 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 NCT01871194, which also lists 1 linked publication.
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 Jan 2018.