Eliquis Regulatory Post Marketing Surveillance

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01885598
First received: June 21, 2013
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

The objective of this regulatory Post-Marketing Surveillance in Korea is to reconfirm the clinical usefulness of Eliquis through collecting, reviewing, identifying and verifying the safety and effectiveness information about Eliquis in general practice


Condition Intervention
NONVALVULAR ATRIAL FIBRILLATION
Drug: Apixaban

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Eliquis (Apixaban) Regulatory Postmarketing Surveillance in Clinical Practice for Stroke Prevention in Nonvalvular Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Occurrence of stroke, systemic embolism and death [ Time Frame: At each visit (3, 6, 12 and 24 months) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 3000
Study Start Date: December 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Nonvalvular Atrial Fibrillation patients with risk of Stroke
Patients undergoing elective total hip replacement arthroplasty or elective total knee replacement arthroplasty and signed on the data release
Drug: Apixaban
Other Name: Eliquis

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic physicians should enroll all adult patients who are diagnosed with nonvalvular atrial fibrillation and who need anticoagulation therapy for risk reduction of stroke and systemic embolism and who are receiving Eliquis 5 mg or 2.5 mg for the first time

Criteria

Inclusion Criteria:

  • ≥19 years of age
  • Adult patients who are diagnosed with nonvalvular atrial fibrillation and are initiating Eliquis anticoagulation therapy for risk reduction of stroke and systemic embolism
  • Patients with evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study

Exclusion Criteria:

  • Receiving Eliquis treatment for an indication that is not approved in Korea
  • Contraindicated for the use of Eliquis as described in the Korean label
  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: NCT01885598

Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

Locations
Korea, Republic of
Local Institution Recruiting
Seoul, Korea, Republic of, 110-756
Contact: Site 0001         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01885598     History of Changes
Other Study ID Numbers: CV185-259
Study First Received: June 21, 2013
Last Updated: August 19, 2014
Health Authority: Korea: Ministry of Food and Drug Safety

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

ClinicalTrials.gov processed this record on September 18, 2014