NCT02792335

Brief Summary

To describe the rate of discontinuation among Non-Valvular Atrial Fibrillation (NVAF) patients who were on warfarin and have switched to the Novel oral anticoagulants(NOACs).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 7, 2016

Completed
Last Updated

June 7, 2016

Status Verified

June 1, 2016

Enrollment Period

2.6 years

First QC Date

June 2, 2016

Last Update Submit

June 6, 2016

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (6)

  • Discontinuation rate of patients with prior warfarin use

    up to 31 months

  • Rate of major bleeding events of patients with prior warfarin use

    up to 31 months

  • Rate of hospitalization due to major bleeding events of patients with warfarin use

    up to 31 months

  • Discontinuation rate of patients who were naïve to oral anticoagulant

    up to 31 months

  • Rate of major bleeding events of patients who were naïve to oral anticoagulant

    up to 31 months

  • Rate of hospitalization due to major bleeding events of patients who were naïve to oral anticoagulant

    up to 31 months

Secondary Outcomes (8)

  • Rate of All-Cause Hospitalization

    up to 31 months

  • Rate of Atrial Fibrillation(AF)-Related Hospitalization

    up to 31 months

  • Rate of All-Cause Any Rehospitalization

    up to 31 months

  • Rate of AF-Related Any Rehospitalization

    up to 31 months

  • Rate of All-Cause Early Hospitalization

    up to 31 months

  • +3 more secondary outcomes

Study Arms (2)

patients naive to oral anticoagulant treatment

NVAF patients naïve to oral anticoagulant treatment (Naïve)

Drug: apixabanDrug: dabigatranDrug: rivaroxaban

patients with prior warfarin therapy

NVAF patients with prior warfarin therapy (Warfarin treated)

Drug: apixabanDrug: dabigatranDrug: rivaroxabanDrug: warfarin

Interventions

apixabanDRUG
patients naive to oral anticoagulant treatmentpatients with prior warfarin therapy
dabigatranDRUG
patients naive to oral anticoagulant treatmentpatients with prior warfarin therapy
rivaroxabanDRUG
patients naive to oral anticoagulant treatmentpatients with prior warfarin therapy
warfarinDRUG
patients with prior warfarin therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The initial study population will include Non-valvular atrial fibrillation (NVAF) patients who initiated warfarin or Novel oral anticoagulants (NOACs) between January 01, 2012 and August 31, 2014. The date of the first NOAC prescription claim during the enrollment period will serve as the index date. The patients who have at least 1 year of baseline data available will be included in the study.

You may qualify if:

  • Individuals with NVAF who were on warfarin and have switched to the NOACs (dabigatran, rivaroxaban and apixaban) within the study period January 01, 2013 through March 31, 2014
  • Individuals ≥18 years old on the index date
  • At least 1 year of baseline period with history of continuous warfarin use in the baseline period for at least 3 months immediately before the index date
  • At least 1 diagnosis of AF in the 12 months prior to index date
  • Continuous eligibility with medical and pharmacy benefits for at least 12 months before the index date through 1 month after the index date

You may not qualify if:

  • Individuals with a diagnosis of valvular heart disease or cardiac surgery during the 12 months prior to index date

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

apixabanDabigatranRivaroxabanWarfarin

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazines4-HydroxycoumarinsCoumarinsBenzopyransPyrans

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2016

First Posted

June 7, 2016

Study Start

January 1, 2012

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

June 7, 2016

Record last verified: 2016-06