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Eliquis Safety Surveillance in Japanese Patients With NonValvular Atrial Fibrillation

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ClinicalTrials.gov Identifier: NCT02007655
Recruitment Status : Active, not recruiting
First Posted : December 11, 2013
Last Update Posted : December 13, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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

Condition or disease Intervention/treatment
NonValvular Atrial Fibrillation Drug: Eliquis

Study Design

Study Type : Observational
Estimated Enrollment : 5500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Eliquis Safety Surveillance in Japanese Patients With NonValvular Atrial Fibrillation
Actual Study Start Date : August 31, 2013
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Apixaban
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Incidence rate of unexpected adverse events [ Time Frame: Day 1 (At Eliquis initiation) ]
  2. Incidence rate of unexpected adverse events [ Time Frame: 12 weeks after initiation ]
  3. Incidence rate of unexpected adverse events [ Time Frame: 52 weeks after initiation ]
  4. Incidence rate of unexpected adverse events [ Time Frame: 104 week (discontinuation) ]
  5. Bleeding events and risk factors of bleeding [ Time Frame: Day 1 (At Eliquis initiation) ]
  6. Bleeding events and risk factors of bleeding [ Time Frame: 12 weeks after initiation ]
  7. Bleeding events and risk factors of bleeding [ Time Frame: 52 weeks after initiation ]
  8. Bleeding events and risk factors of bleeding [ Time Frame: 104 week (discontinuation) ]
  9. Ancillary baseline variables that may also be associated with adverse outcomes [ Time Frame: Day 1 (At Eliquis initiation) ]
  10. Ancillary baseline variables that may also be associated with adverse outcomes [ Time Frame: 12 weeks after initiation ]
  11. Ancillary baseline variables that may also be associated with adverse outcomes [ Time Frame: 52 weeks after initiation ]
  12. Ancillary baseline variables that may also be associated with adverse outcomes [ Time Frame: 104 week (discontinuation) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02007655


Locations
Japan
Local Institution
Toyama-shi, Toyama, Japan, 930-0194
Sponsors and Collaborators
Bristol-Myers Squibb
Pfizer
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02007655     History of Changes
Other Study ID Numbers: CV185-286
First Posted: December 11, 2013    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017

Keywords provided by Bristol-Myers Squibb:
Cardiovascular

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Apixaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants