Venous ThromboembolismNCT01885585
Eliquis Regulatory Post Marketing Surveillance (rPMS)
An observational study of Venous Thromboembolism, run by Bristol-Myers Squibb at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- Apixaban
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2014to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Signed data release
- Patients undergoing elective total hip replacement arthroplasty or elective total knee replacement arthroplasty
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Eliquis (Apixaban) Regulatory Post Marketing Surveillance in Clinical Practice for Venous Thromboembolism (VTE) Prevention
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
- Conditions
- Venous Thromboembolism
- Being tested
- Apixaban
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApixabanDrug
Also called Eliquis
| Study group | Role | What they receive |
|---|---|---|
| Patients with risk of VTE | Patients undergoing elective total hip replacement arthroplasty or elective total knee replacement arthroplasty and signed on the data release Receives: Drug: Apixaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events (AEs) and serious AEs
Measured: Up to 30 days after last study drug dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study startJul 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01885585
- Sponsor's protocol ID
- CV185-222
- Status last verified
- Feb 2016
- First submitted
- 21 Jun 2013
- Last updated
- 8 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eliquis (Apixaban) Regulatory Post Marketing Surveillance in Clinical Practice for Venous Thromboembolism (VTE) Prevention
- ClinicalTrials.gov ID
- NCT01885585
- Acronym / sponsor ID
- CV185-222
- Conditions
- Venous Thromboembolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 25 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with risk of VTE | – | Drug: ApixabanPatients undergoing elective total hip replacement arthroplasty or elective total knee replacement arthroplasty and signed on the data release |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Signed data release
- Patients undergoing elective total hip replacement arthroplasty or elective total knee replacement arthroplasty
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApixabanAlso: Eliquis | Drug | Patients with risk of VTE |
Primary outcome
Number of Adverse Events (AEs) and serious AEs
Time frame: Up to 30 days after last study drug dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism, run by Bristol-Myers Squibb at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events (AEs) and serious AEs (time frame: Up to 30 days after last study drug dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2016.