Direct Oral Anticoagulants and Venous Thromboembolism

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Canadian Network for Observational Drug Effect Studies, CNODES
• Collaborators: Canadian Institutes of Health Research (CIHR); Drug Safety and Effectiveness Network, Canada
• Treatments: Anticoagulants; Apixaban; Dabigatran; Polystyrene sulfonic acid; Rivaroxaban; Warfarin

Criteria

Inclusion Criteria:

• Patients with a new prescription for a DOAC or warfarin that had an incident diagnosis of VTE within the 30 days prior to the date of the prescription

• Patients at least 18 years of age (except Nova Scotia, Ontario, and Alberta, where patients will be at least 66 years of age)

• Patients with at least 1 year of history in the database

Exclusion Criteria:

• Patients with a diagnosis of VTE or atrial fibrillation ≤335 days prior to the incident VTE diagnosis

• Patients that received a prescription for a DOAC or warfarin within 1 year prior to the date of the cohort entry

• Patients who received prescriptions for both a DOAC and warfarin on the date of cohort entry