Trial Condition(s):

Anticoagulation

Safety and utilization of Rivaroxaban in the secondary care setting in England

Bayer Identifier:

16171

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

Study Completed

Trial Purpose

The overall aim of this Specialist Cohort Event Monitoring (SCEM) study is to proactively monitor the short-term (up to three months) safety and drug utilisation of rivaroxaban as prescribed to patients for medical conditions requiring anticoagulation by specialists in the secondary care setting in England. The study aims to collect exposure and outcome data for a cohort of approximately 2000 evaluable patients over a three year period.

Inclusion Criteria
-  Adult (> 18 years?) patients prescribed rivaroxaban for all medical indications requiring anticoagulation (and surgical indications other than elective major hip or knee replacement).
Exclusion Criteria
-  Patients who commenced rivaroxaban between date of market launch and study start
 -  Initial survey questionnaire is not submitted within three months of the index date
 -  Baseline and three month questionnaires are returned blank
-  Specialist reports that the patient did not take or was never prescribed rivaroxaban

Trial Summary

Enrollment Goal
4621
Trial Dates
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Phase
4
Could I receive a placebo?
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many locations, United Kingdom

Status
Completed
 

Trial Design