NCT01885585

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 25, 2013

Completed
1 year until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

February 8, 2016

Status Verified

February 1, 2016

Enrollment Period

10 months

First QC Date

June 21, 2013

Last Update Submit

February 5, 2016

Conditions

Venous Thromboembolism

Outcome Measures

Primary Outcomes (1)

  • Number of Adverse Events (AEs) and serious AEs

    Up to 30 days after last study drug dose

Study Arms (1)

Patients with risk of VTE

Patients undergoing elective total hip replacement arthroplasty or elective total knee replacement arthroplasty and signed on the data release

Drug: Apixaban

Interventions

ApixabanDRUG
Also known as: Eliquis
Patients with risk of VTE

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinic Patients must be ≥19 years of age, at risk for venous thrombosis, and have elected to undergo total hip replacement arthroplasty or total knee replacement arthroplasty will be included in this study

You may qualify if:

  • Signed data release
  • Patients undergoing elective total hip replacement arthroplasty or elective total knee replacement arthroplasty

You may not qualify if:

  • Being treated for an indication not approved for the use of Eliquis® in Korea
  • Is contraindicated for the use of Eliquis® as described in the Korean label

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Seoul, 110-744, South Korea

Location

Related Links

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

apixaban

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2013

First Posted

June 25, 2013

Study Start

July 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

February 8, 2016

Record last verified: 2016-02

Locations

KR(1)