Early Post-Marketing Study of ELIQUIS (Apixaban) in Mexico

Pulmonary Embolism Clinical Trial

Official title:

Early Post-Marketing Study of Eliquis (Apixaban), in Treatment of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE), and Prevention of Recurrent DVT and PE in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02345343
• Other study ID #: CV185-399
• Status: Completed
• Phase: N/A
• First received: January 16, 2015
• Last updated: June 27, 2017
• Start date: May 4, 2015
• Est. completion date: October 7, 2015

Study information

• Verified date: June 2017
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary objective of the study is to report adverse events of on-treatment AEs by the treating physicians during a specified 24-month study period in patients with venous thromboembolism at the sentinel site(s) for the National Center of Pharmacovigilance (CNFV) in Mexico.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 7, 2015
• Est. primary completion date: October 7, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Patients 18 years old with DVT and PE at the sentinel site who received at least 1 dose of apixaban for the treatment and/or prevention of recurrence of DVT and PE 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 approved

• Contraindications included in the approved Mexican prescribing information

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Embolism
• Pulmonary Embolism
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• Apixaban

Locations

Country	Name	City	State
Mexico	Local Institution	Queretaro

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of adverse events (AEs) notified to health authorities (HAs) of on-treatment AEs by the treating physicians		Up to 24-month study period
Secondary	The AEs reported to HA in a table format identifying the report number, patient ID number, and type of AE		Up to 24-month study period

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form