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Non-valvular Atrial Fibrillation (NVAF) | Early Post-marketing Study of Eliquis (Apixaban)

Non-valvular Atrial Fibrillation (NVAF) research study

What is the primary objective of this study?

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.

Who is eligible to participate?

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - 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 Exclusion Criteria: - 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)

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Non-valvular Atrial Fibrillation (NVAF)

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Apixaban

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

NVAF patients in Mexico treated with ApixabanAll 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

Study Status

Withdrawn

Start Date: April 2014

Completed Date: November 2015

Phase:

Type: Observational

Design:

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

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Bristol-Myers Squibb

Lead Sponsor: Bristol-Myers Squibb

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02153424

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