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
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many locations, United Kingdom | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
An observational post-authorization safety specialist cohort event monitoring study (SCEM) to monitor the safety and utilization of Rivaroxaban (Xarelto®) in the secondary care setting in England
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Quantification of the cumulative incidence of selected identified risks in real life clinical practice (i.e. major and minor bleeding composite outcomes which meet pre-specified per-protocol definitions)Timeframe: Up to 3 month
Secondary Outcome
- Advancing the understanding of the patient population prescribed Rivaroxaban in the secondary care settingTimeframe: Up to 3 month
- Use of Rivaroxaban outside terms of marketing authorisation (‘off-label’)Timeframe: Up to 3 month
- Number of Adverse Events reported in the three month observation periodTimeframe: Up to 3 month
Additional Information
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