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Direct Oral Anticoagulants and Venous Thromboembolism

NCT02833987 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 59525

Last updated 2018-01-11

No results posted yet for this study

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.

Conditions

  • Venous Thromboembolism
  • Major Bleed

Interventions

DRUG

Apixaban (ATC B01AF02)

Exposure to apixaban (ATC B01AF02) will be defined as a new prescription for apixaban in the 30 days following the date of an incident VTE diagnosis.

DRUG

Dabigatran (ATC B01AE07)

Exposure to dabigatran (ATC B01AE07) will be defined as a new prescription for dabigatran in the 30 days following the date of an incident VTE diagnosis.

DRUG

Rivaroxaban (ATC B01AF01)

Exposure to rivaroxaban (ATC B01AF01) will be defined as a new prescription for rivaroxaban in the 30 days following the date of an incident VTE diagnosis.

DRUG

Warfarin (ATC B01AA03)

Exposure to warfarin (ATC B01AA03) will be defined as a new prescription for warfarin in the 30 days following the date of an incident VTE diagnosis.

Sponsors & Collaborators

  • Drug Safety and Effectiveness Network, Canada

    collaborator OTHER

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Canadian Network for Observational Drug Effect Studies, CNODES

    lead OTHER

Principal Investigators

  • Brenda Hemmelgarn, MD, PhD · Department of Community Health Sciences, University of Calgary

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02833987 on ClinicalTrials.gov