Non-valvular Atrial Fibrillation (NVAF) Clinical Trial
Official title:
Early Post-marketing Study of Eliquis (Apixaban)
| Verified date | August 2016 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Mexico: Secretaria de Salud |
| Study type | Observational |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | November 2015 |
| Est. primary completion date | November 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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) |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Mexico | Local Institution | Guadalajara | Jalisco |
| Mexico | Local Institution | Puebla |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
Mexico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Determine the reporting rate of on-treatment adverse events (AEs) by the treating physicians | Up to 24 month study period | Yes | |
| Primary | 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 | Yes |
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|---|---|---|---|
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