Early Post-marketing Study of Eliquis (Apixaban)
- Registration Number
- NCT02153424
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description NVAF patients in Mexico treated with Apixaban 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
- Primary Outcome Measures
Name Time Method 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 Determine the reporting rate of on-treatment adverse events (AEs) by the treating physicians Up to 24 month study period
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Local Institution
🇲🇽Puebla, Mexico