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

Both

Age

18 - N/A
  • - Adult (> 18 years?) patients prescribed rivaroxaban for all medical indications requiring anticoagulation (and surgical indications other than elective major hip or knee replacement).

  • - 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
September 2013 - May 2017
Phase
Phase 4
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
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 month
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Advancing the understanding of the patient population prescribed Rivaroxaban in the secondary care setting
    date_rangeTime Frame:
    Up to 3 month
    enhanced_encryption
    Safety Issue:
    No
  • Use of Rivaroxaban outside terms of marketing authorisation (‘off-label’)
    date_rangeTime Frame:
    Up to 3 month
    enhanced_encryption
    Safety Issue:
    No
  • Number of Adverse Events reported in the three month observation period
    date_rangeTime Frame:
    Up to 3 month
    enhanced_encryption
    Safety Issue:
    Yes

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
N/A

Additional Information

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