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

Atrial Fibrillation Clinical Trial

— ROSE  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01871194
• Other study ID #: ROSE
• Status: Completed
• Phase: N/A
• First received: May 29, 2013
• Last updated: January 26, 2018
• Start date: May 2013
• Est. completion date: September 2017

Study information

• Verified date: January 2018
• Source: Drug Safety Research Unit, Southampton, UK
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3400
• Est. completion date: September 2017
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Deep Vein Thrombosis
• Embolism
• Pulmonary Embolism
• Thrombosis
• Venous Thrombosis

Locations

Country	Name	City	State
United Kingdom	Drug Safety Research Unit	Southampton	Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Professor Saad Shakir	Bayer

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	During 12 weeks after initiation of treatment with rivaroxaban or alternative anticoagulant therapy