NCT03508258

Brief Summary

Study of patients with nonvalvular atrial fibrillation (NVAF) who are newly prescribed NOACs (Novel Oral Anticoagulants) in routine clinical practice in England

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

September 1, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 25, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

June 30, 2022

Status Verified

June 1, 2022

Enrollment Period

1 year

First QC Date

April 16, 2018

Last Update Submit

June 28, 2022

Conditions

Non-valvular Atrial Fibrillation

Outcome Measures

Primary Outcomes (7)

  • Incidence of major bleeding

    At the end of 1 year

  • Incidence of intracranial bleeding

    At the end of 1 year

  • Incidence of gastrointestinal bleeding

    At the end of 1 year

  • Incidence of clinically relevant non-major bleeding

    At the end of 1 year

  • Incidence of ischemic stroke

    At the end of 1 year

  • Incidence of unspecified stroke

    At the end of 1 year

  • Incidence of systemic embolic events

    At the end of 1 year

Study Arms (2)

Participants with NVAF starting Apixaban

Other: Non-interventional

Participants with NVAF starting Warfarin

Other: Non-Interventional

Interventions

Non-InterventionalOTHER

Non-interventional

Participants with NVAF starting Apixaban

Eligibility Criteria

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

NVAF patients newly prescribed NOACs in England

You may qualify if:

  • Diagnosis of atrial fibrillation at or prior to index (the initiation of treatment)
  • Incident prescription of an oral anticoagulant (index date)
  • Patients with at least one year of computerized data prior to index date

You may not qualify if:

  • Patients identified with a diagnosis of mechanical heart valve replacement or mitral stenosis identified at any point in the pre-index period in either CPRD by Read codes or in HES as ICD-10/OPCS codes
  • Patients with indication of venous thromboembolism (pulmonary embolism or deep vein thrombosis) identified in in either CPRD by Read codes or HES by ICD-10/OPCS codes within 3 months prior to index

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Bethesda, Maryland, 20814, United States

Location

Related Links

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR
0

Study Design

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

Study Record Dates

First Submitted

April 16, 2018

First Posted

April 25, 2018

Study Start

September 1, 2017

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

June 30, 2022

Record last verified: 2022-06

Locations

US(1)