Overview

This trial is active, not recruiting.

Condition nonvalvular atrial fibrillation
Treatment eliquis
Sponsor Bristol-Myers Squibb
Collaborator Pfizer
Start date August 2013
End date August 2018
Trial size 5500 participants
Trial identifier NCT02007655, CV185-286

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
Patients who are beginning to receive the treatment with Eliquis under the approved indications, dosage, and administration will be included in this study
eliquis Apixaban

Primary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Eliquis Safety Surveillance in Japanese Patients With NonValvular Atrial Fibrillation
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.