check_circleStudy Completed
Anticoagulation
Bayer Identifier:
16171
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
Safety and utilization of Rivaroxaban in the secondary care setting in England
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.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
4621Trial Dates
September 2013 - May 2017Phase
Phase 4Could I Receive a placebo
NoProducts
Xarelto (Rivaroxaban, BAY59-7939)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many locations, United Kingdom |
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)date_rangeTime Frame:Up to 3 monthenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Advancing the understanding of the patient population prescribed Rivaroxaban in the secondary care settingdate_rangeTime Frame:Up to 3 monthenhanced_encryptionNoSafety Issue:
- Use of Rivaroxaban outside terms of marketing authorisation (‘off-label’)date_rangeTime Frame:Up to 3 monthenhanced_encryptionNoSafety Issue:
- Number of Adverse Events reported in the three month observation perioddate_rangeTime Frame:Up to 3 monthenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A