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An Observational Post-Authorization Safety Specialist Cohort Event Monitoring Study (SCEM) to Monitor the Safety and Utilization of Rivaroxaban (Xarelto®). (ROSE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01871194
Recruitment Status : Completed
First Posted : June 6, 2013
Last Update Posted : January 30, 2018
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Professor Saad Shakir, Drug Safety Research Unit, Southampton, UK

Study Description
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Brief 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 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.

Condition or disease
Atrial Fibrillation Deep Vein Thrombosis Pulmonary Embolism

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 3400 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Weeks
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.
Study Start Date : May 2013
Actual Primary Completion Date : January 2016
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

Groups and Cohorts
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Group/Cohort
Rivaroxaban
This is a non-interventional study
Alternative anticoagulant therapy
This is a non-interventional study


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01871194


Locations
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United Kingdom
Drug Safety Research Unit
Southampton, Hampshire, United Kingdom, SO31 1AA
Sponsors and Collaborators
Professor Saad Shakir
Bayer
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Professor Saad Shakir, Director, Drug Safety Research Unit, Southampton, UK
ClinicalTrials.gov Identifier: NCT01871194    
Other Study ID Numbers: ROSE
First Posted: June 6, 2013    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Pulmonary Embolism
Atrial Fibrillation
Thrombosis
Embolism
Venous Thrombosis
Arrhythmias, Cardiac
Heart Diseases
 Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Lung Diseases
Respiratory Tract Diseases