Status:
COMPLETED
An Observational Post-Authorization Safety Specialist Cohort Event Monitoring Study (SCEM) to Monitor the Safety and Utilization of Rivaroxaban (Xarelto®).
Lead Sponsor:
Professor Saad Shakir
Collaborating Sponsors:
Bayer
Conditions:
Atrial Fibrillation
Deep Vein Thrombosis
Eligibility:
All Genders
18+ years
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2017
Estimated Enrollment :
3400 Patients enrolled
Trial Details
Trial ID
NCT01871194
Start Date
May 1 2013
End Date
September 1 2017
Last Update
January 30 2018
Active Locations (1)
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1
Drug Safety Research Unit
Southampton, Hampshire, United Kingdom, SO31 1AA