Direct Oral Anticoagulants and Venous Thromboembolism
Status:
Completed
Trial end date:
2015-03-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to determine whether use of direct oral anticoagulants (DOACs)
is associated with an increased risk of major bleeding compared to warfarin use, for the
treatment of venous thromboembolism (VTE).
The investigators will carry out separate population based cohort studies using health
administrative databases in eight jurisdictions in Canada, the UK and the US. Cohorts will be
defined by the initiation of a DOAC or warfarin on or after January 1, 2009, with an incident
diagnosis of VTE having occurred within 30 days prior to the date of the prescription for the
DOAC or warfarin. Follow-up will continue until a hospitalization or emergency department
visit for a major bleed. The results from separate sites will be combined to provide an
overall assessment of the risk of major bleeding in DOAC users.
Details
Lead Sponsor:
Canadian Network for Observational Drug Effect Studies, CNODES
Collaborators:
Canadian Institutes of Health Research (CIHR) Drug Safety and Effectiveness Network, Canada