MedTrace Logo

Direct Oral Anticoagulants in Patients With Atrial Fibrillation (DOACs vs DOACs)

NCT03568916 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 227579

Last updated 2021-01-08

No results posted yet for this study

Summary

The purpose of this study is to assess safety and effectiveness of direct oral anticoagulants (DOACs) for stroke prevention in patients with non-valvular atrial fibrillation (AF). The comparison of DOACs between themselves is of interest.

The investigators will carry out separate population-based, matched cohort studies, using health administrative databases in nine jurisdictions in Canada, the UK and the US. New users of DOACs for stroke prevention in non-valvular AF will be eligible to enter the cohorts. Follow-up will continue until a hospitalization or emergency department visit for a stroke. The results from the separate sites will be combined by meta-analysis to provide an overall assessment of the safety and effectiveness of the different anticoagulation regimens in stroke prevention in AF.

The investigators hypothesize that different DOACs will have similar safety and effectiveness profiles.

Conditions

Interventions

DRUG

Apixaban (ATC B01AF02)

Exposure to apixaban (ATC B01AF02) will be defined as a new prescription for apixaban at cohort entry date in patients diagnosed with non-valvular atrial fibrillation. Patients are considered exposed until end of follow-up regardless of switch or interruption.

DRUG

Dabigatran (ATC B01AE07)

Exposure to dabigatran (ATC B01AE07) will be defined as a new prescription for dabigatran at cohort entry date in patients diagnosed with non-valvular atrial fibrillation. Patients are considered exposed until end of follow-up regardless of switch or interruption.

DRUG

Rivaroxaban (ATC B01AF01)

Exposure to rivaroxaban (ATC B01AF01) will be defined as a new prescription for rivaroxaban at cohort entry date in patients diagnosed with non-valvular atrial fibrillation. Patients are considered exposed until end of follow-up regardless of switch or interruption.

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

  • Madeleine Durand, MD, MSc, FRCPC · Centre de Recherche du Centre Hospitalier de l'Université de Montréal

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT03568916 on ClinicalTrials.gov