NCT02153424

Brief Summary

The primary objective of the study is to identify and describe any suspected (AEs) in all patients with NVAF treated with Apixaban, as a request of the National Center of Pharmacovigilance (CNFV) in Mexico.

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 Apr 2014

Geographic Reach
1 country

2 active sites

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withdrawn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

April 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 3, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

August 17, 2016

Status Verified

August 1, 2016

Enrollment Period

1.6 years

First QC Date

May 30, 2014

Last Update Submit

August 15, 2016

Conditions

Non-valvular Atrial Fibrillation (NVAF)

Outcome Measures

Primary Outcomes (2)

  • Determine the reporting rate of on-treatment adverse events (AEs) by the treating physicians

    Up to 24 month study period

  • Identify, describe, and report any suspected AEs that occur while on treatment with Apixaban or preventing stroke and systemic embolism in patients with NVAF

    Up to 24 months

Study Arms (1)

NVAF patients in Mexico treated with Apixaban

All patients with NVAF at the sentinel site for the CNFV in Mexico who received at least 1 dose of Apixaban to reduce the risk of stroke or systemic embolism during the specified 24-month study period

Drug: Apixaban

Interventions

ApixabanDRUG
Also known as: Eliquis
NVAF patients in Mexico treated with Apixaban

Eligibility Criteria

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

The sentinel site for the CNFV in Mexico

You may qualify if:

  • All patients with NVAF at the sentinel site for the CNFV in Mexico who received at least 1 dose of Apixaban to reduce the risk of stroke or systemic embolism during the specified 24-month study period

You may not qualify if:

  • Subjects who received Apixaban as part of a clinical trial
  • Subjects who received Apixaban for any indication other than local approval (ie, to reduce the risk of stroke and systemic embolism in patients with NVAF)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Local Institution

Guadalajara, Jalisco, 442003, Mexico

Location

Local Institution

Puebla City, Puebla, 72040, Mexico

Location

Related Links

MeSH Terms

Interventions

apixaban

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2014

First Posted

June 3, 2014

Study Start

April 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

August 17, 2016

Record last verified: 2016-08

Locations

ME(2)