Eliquis Safety Surveillance in Japanese Patients With NonValvular Atrial Fibrillation

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Bristol-Myers Squibb
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02007655
First received: December 6, 2013
Last updated: September 24, 2014
Last verified: September 2014
  Purpose

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

Condition Intervention
NonValvular Atrial Fibrillation
Drug: Eliquis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Eliquis Safety Surveillance in Japanese Patients With NonValvular Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Incidence rate of unexpected adverse events [ Time Frame: Day 1 (At Eliquis initiation) ] [ Designated as safety issue: Yes ]
  • Incidence rate of unexpected adverse events [ Time Frame: 12 weeks after initiation ] [ Designated as safety issue: Yes ]
  • Incidence rate of unexpected adverse events [ Time Frame: 52 weeks after initiation ] [ Designated as safety issue: Yes ]
  • Incidence rate of unexpected adverse events [ Time Frame: 104 week (discontinuation) ] [ Designated as safety issue: Yes ]
  • Bleeding events and risk factors of bleeding [ Time Frame: Day 1 (At Eliquis initiation) ] [ Designated as safety issue: Yes ]
  • Bleeding events and risk factors of bleeding [ Time Frame: 12 weeks after initiation ] [ Designated as safety issue: Yes ]
  • Bleeding events and risk factors of bleeding [ Time Frame: 52 weeks after initiation ] [ Designated as safety issue: Yes ]
  • Bleeding events and risk factors of bleeding [ Time Frame: 104 week (discontinuation) ] [ Designated as safety issue: Yes ]
  • Ancillary baseline variables that may also be associated with adverse outcomes [ Time Frame: Day 1 (At Eliquis initiation) ] [ Designated as safety issue: Yes ]
  • Ancillary baseline variables that may also be associated with adverse outcomes [ Time Frame: 12 weeks after initiation ] [ Designated as safety issue: Yes ]
  • Ancillary baseline variables that may also be associated with adverse outcomes [ Time Frame: 52 weeks after initiation ] [ Designated as safety issue: Yes ]
  • Ancillary baseline variables that may also be associated with adverse outcomes [ Time Frame: 104 week (discontinuation) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 5500
Study Start Date: September 2013
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Eliquis on Nonvalvular Atrial Fibrilliation patients
Patients who are beginning to receive the treatment with Eliquis under the approved indications, dosage, and administration will be included in this study
Drug: Eliquis
Other Names:
  • Apixaban
  • BMS-562247

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

University hospitals, general hospitals, and clinics that have relevant departments, such as cardiology, cerebrovascular medicine, neurology, internal medicine, neurosurgery, etc, where the surveillance drug is mainly prescribed

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02007655

Contacts
Contact: For Site information please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial site that are recruiting have contact information at this time

Locations
Japan
Local Institution Recruiting
Toyama, Japan, 930-8555
Contact: Site 0001         
Sponsors and Collaborators
Bristol-Myers Squibb
Pfizer
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02007655     History of Changes
Other Study ID Numbers: CV185-286
Study First Received: December 6, 2013
Last Updated: September 24, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Bristol-Myers Squibb:
Cardiovascular

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014