Eliquis Safety Surveillance in Japanese Patients With NonValvular Atrial Fibrillation

NonValvular Atrial Fibrillation Clinical Trial

Official title:

Eliquis Safety Surveillance in Japanese Patients With NonValvular Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02007655
• Other study ID #: CV185-286
• Status: Completed
• Start date: September 1, 2013
• Est. completion date: August 31, 2016

Study information

• Verified date: June 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary objectives of this study are:

• To estimate the incidence rate of unexpected adverse events

• To characterize the bleeding events and assess risk factors of bleeding

• To identify ancillary baseline variables that may also be associated with adverse outcomes

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6372
• Est. completion date: August 31, 2016
• Est. primary completion date: August 31, 2016
• 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 who are beginning to receive the treatment with this product under the approved indications, dosage, and administration will be included in this study

Exclusion Criteria:

• Patients who are receiving Eliquis outside of its approved indication will be excluded from this study

Related Conditions & MeSH terms

• Atrial Fibrillation
• NonValvular Atrial Fibrillation

Intervention

Drug:
• Eliquis

Locations

Country	Name	City	State
Japan	Local Institution	Toyama-shi	Toyama

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of unexpected adverse events		Day 1 (At Eliquis initiation)
Primary	Incidence rate of unexpected adverse events		12 weeks after initiation
Primary	Incidence rate of unexpected adverse events		52 weeks after initiation
Primary	Incidence rate of unexpected adverse events		104 week (discontinuation)
Primary	Bleeding events and risk factors of bleeding		Day 1 (At Eliquis initiation)
Primary	Bleeding events and risk factors of bleeding		12 weeks after initiation
Primary	Bleeding events and risk factors of bleeding		52 weeks after initiation
Primary	Bleeding events and risk factors of bleeding		104 week (discontinuation)
Primary	Ancillary baseline variables that may also be associated with adverse outcomes		Day 1 (At Eliquis initiation)
Primary	Ancillary baseline variables that may also be associated with adverse outcomes		12 weeks after initiation
Primary	Ancillary baseline variables that may also be associated with adverse outcomes		52 weeks after initiation
Primary	Ancillary baseline variables that may also be associated with adverse outcomes		104 week (discontinuation)

External Links

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