Stroke, Systemic Embolism, VTEt and VTEpNCT02339818
Evaluation of the Effectiveness of Eliquis ® (Apixaban) Risk Minimization Tools in European Economic Area (EEA) Countries
An observational study of Stroke, Systemic Embolism, VTEt and VTEp, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The main purpose is to evaluate the effectiveness of the Eliquis® (apixaban) Prescriber Guide and Patient Alert Card in terms knowledge of the important identified risk of bleeding associated with Eliquis treatment communicated by the RM tools. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Systemic Embolism, VTEt and VTEp
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Feb 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HCPs will be considered for participation in the study if they prescribe/use Eliquis for any approved indications, including the following subgroups as appropriate for each country: * Cardiologists (including allied specialties, e.g. angiologists, electrophysiologists) * Non-cardiology specialists (e.g. internal medicine/hospital general medicine physicians, geriatricians/care of the elderly physicians, neurologists, hematologists, orthopedic surgeons) * General practitioners/internal medicine * Other HCPs (e.g. nurses, pharmacists) * Patients taking Eliquis for all three currently approved indications
Who may be able to join
- HCP must have been involved in the treatment of at least one patient with Eliquis for any approved indication
- Patients must have taken Eliquis for any approved indication
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The main purpose is to evaluate the effectiveness of the Eliquis® (apixaban) Prescriber Guide and Patient Alert Card in terms knowledge of the important identified risk of bleeding associated with Eliquis treatment communicated by the RM tools.
Read the detailed description
Observational Model, Other- This is a non-interventional, cross-sectional study in the EEA involving representative samples of HCPs who treat patients with Eliquis, as well as patients treated with Eliquis. This study will be facilitated via web-based surveys used to evaluate the effectiveness of the Eliquis Prescribe Guide and Patient Alert Card as risk management tools.
Enrollment: 384 Health Care Professions (HCPs) and 192 Patients
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of recurrent DVT and PE in adults (VTEt)
Prevention of VTE in adult patients knee replacement surgery (VTEp)
- Conditions
- Stroke, Systemic Embolism, VTEt and VTEp
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HCPs | HCPs involved in using Eliquis (apixaban) | |
| Patients | Patients taking Eliquis for any of the three currently approved indications |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportions of HCPs using Eliquis and patients treated with Eliquis with knowledge of the important identified risk of bleeding associated with Eliquis treatment measured through web-based survey results
Measured: At the time of completion of a survey (approximately 6 to 12 months)
Secondary outcomes (3)
The proportions of HCPs using Eliquis and patients treated with Eliquis who have received the Risk minimization (RM) tools measured through web-based survey results
Measured: At the time of completion of a survey (approximately 6 to 12 months)
The proportions of HCPs using Eliquis and patients treated with Eliquis who have utilized the RM tools, and the extent of tool usage measured through web-based survey results
Measured: At the time of completion of a survey (approximately 6 to 12 months)
The levels and distributions of behavior questionnaire results for HCPs and patients measured through web-based survey results
Measured: At the time of completion of a survey (approximately 6 to 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2015 (estimated)
- Study startAug 2015
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke, Systemic Embolism, VTEt and VTEpStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02339818
- Sponsor's protocol ID
- CV185-365
- Status last verified
- Mar 2017
- First submitted
- 13 Jan 2015
- Last updated
- 8 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Mayall S, Kahlon R, Al-Dakkak I, Shen SW. Evaluating the Effectiveness of Apixaban Additional Risk Minimisation Measures Using Surveys in Europe. Pharmaceut Med. 2021 Mar;35(2):123-135. doi: 10.1007/s40290-021-00380-1. Epub 2021 Mar 4.
PubMed 33660230
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Eliquis ® (Apixaban) Risk Minimization Tools in European Economic Area (EEA) Countries
- ClinicalTrials.gov ID
- NCT02339818
- Acronym / sponsor ID
- CV185-365
- Conditions
- Stroke, Systemic Embolism, VTEt and VTEp
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- Aug 2015
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 15 Jan 2015 (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 main purpose is to evaluate the effectiveness of the Eliquis® (apixaban) Prescriber Guide and Patient Alert Card in terms knowledge of the important identified risk of bleeding associated with Eliquis treatment communicated by the RM tools.
Detailed description
Observational Model, Other- This is a non-interventional, cross-sectional study in the EEA involving representative samples of HCPs who treat patients with Eliquis, as well as patients treated with Eliquis. This study will be facilitated via web-based surveys used to evaluate the effectiveness of the Eliquis Prescribe Guide and Patient Alert Card as risk management tools.
Enrollment: 384 Health Care Professions (HCPs) and 192 Patients
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of recurrent DVT and PE in adults (VTEt)
Prevention of VTE in adult patients knee replacement surgery (VTEp)
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCPs | – | –HCPs involved in using Eliquis (apixaban) |
| Patients | – | –Patients taking Eliquis for any of the three currently approved indications |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HCPs will be considered for participation in the study if they prescribe/use Eliquis for any approved indications, including the following subgroups as appropriate for each country: * Cardiologists (including allied specialties, e.g. angiologists, electrophysiologists) * Non-cardiology specialists (e.g. internal medicine/hospital general medicine physicians, geriatricians/care of the elderly physicians, neurologists, hematologists, orthopedic surgeons) * General practitioners/internal medicine * Other HCPs (e.g. nurses, pharmacists) * Patients taking Eliquis for all three currently approved indications
Key inclusion criteria (2 listed)
- HCP must have been involved in the treatment of at least one patient with Eliquis for any approved indication
- Patients must have taken Eliquis for any approved indication
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The proportions of HCPs using Eliquis and patients treated with Eliquis with knowledge of the important identified risk of bleeding associated with Eliquis treatment measured through web-based survey results
Time frame: At the time of completion of a survey (approximately 6 to 12 months)
3 secondary outcomes
The proportions of HCPs using Eliquis and patients treated with Eliquis who have received the Risk minimization (RM) tools measured through web-based survey results
Time frame: At the time of completion of a survey (approximately 6 to 12 months)
The proportions of HCPs using Eliquis and patients treated with Eliquis who have utilized the RM tools, and the extent of tool usage measured through web-based survey results
Time frame: At the time of completion of a survey (approximately 6 to 12 months)
The levels and distributions of behavior questionnaire results for HCPs and patients measured through web-based survey results
Time frame: At the time of completion of a survey (approximately 6 to 12 months)
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 Mar 2017.
- Derived from this study: PubMed 33660230Mayall S, Kahlon R, Al-Dakkak I, Shen SW. Evaluating the Effectiveness of Apixaban Additional Risk Minimisation Measures Using Surveys in Europe. Pharmaceut Med. 2021 Mar;35(2):123-135. doi: 10.1007/s40290-021-00380-1. Epub 2021 Mar 4.
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 Stroke, Systemic Embolism, VTEt and VTEp, run by Bristol-Myers Squibb at 1 site in United States.
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 0 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 Mar 2017. 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 United States. 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?
The proportions of HCPs using Eliquis and patients treated with Eliquis with knowledge of the important identified risk of bleeding associated with Eliquis treatment measured through web-based survey results (time frame: At the time of completion of a survey (approximately 6 to 12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02339818, which also lists 1 linked publication.
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 Mar 2017.