Venous ThromboembolismNCT02546817
Eliquis (VTE Treatment and Prevention of Recurrent VTE) rPMS
An observational study of Venous Thromboembolism, run by Bristol-Myers Squibb at 1 site in South Korea.
Trial summary
To assess the real-world safety/effectiveness of Eliquis in Korean venous thromboembolism (VTE) patients and patient characteristics that are associated with bleeding among patients taking Eliquis. To identify factors that might be associated with the safety and effectiveness profile in Korean VTE patients. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Venous Thromboembolism
- How many people
- 29 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Nov 2015to 29 Sep 2017
- How long will I take part?
- 2 Years
- 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: Adult (≥19 years of age) patients who are initiating treatment with Eliquis for the treatment of VTE or prevention of recurrent VTE for the first time
Who may be able to join
- Adult (≥19 years of age) patients who are initiating treatment with Eliquis for the treatment of VTE or prevention of recurrent VTE for the first time in accordance with the Korean package insert will be enrolled in the study
Who cannot join
- Patients with prior treatment with Eliquis before enrollment in this study
- Patients receiving Eliquis treatment for an indication not approved indication in Korea
- Patients meeting any of the following criteria will not be included in the study:
- Hypersensitivity to the active substance or to any of the excipients
- Clinically significant active bleeding
- Hepatic disease associated with coagulopathy and clinically relevant bleeding risk
Show all 22Show fewer
- Patients with increased bleeding risk due to such as following diseases:
- Recent gastrointestinal ulceration history
- Recent intracranial or intracerebral haemorrhage history
- Intraspinal or intracerebral vascular abnormalities
- Recent brain, spinal or ophthalmic surgery history
- Recent brain or spinal injury
- Known or suspected oesophageal varices
- Arteriovenous malformations
- Vascular aneurysms
- Patients with malignant neoplasms at high risk of bleeding
- Concomitant treatment with any other anticoagulant agent:
- Unfractionated heparin (UFH)
- Low molecular weight heparins (enoxaparin, dalteparin, etc)
- Heparin derivatives (fondaparinux, etc)
- oral anticoagulants (warfarin, rivaroxaban, dabigatran, etc) except under the circumstances of switching therapy to or from apixaban or when UFH is given at doses necessary to maintain a patent central venous or arterial catheter
- Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Eliquis (Apixaban) Regulatory Postmarketing Surveillance In Real World Practice (rPMS) For Venous Thromboembolism (VTE) Treatment And Prevention Of Recurrent VTE
To assess the real-world safety/effectiveness of Eliquis in Korean venous thromboembolism (VTE) patients and patient characteristics that are associated with bleeding among patients taking Eliquis. To identify factors that might be associated with the safety and effectiveness profile in Korean VTE patients.
- Conditions
- Venous Thromboembolism
- Keywords
- Treatment, Tx, Prevent
- Medical subject headings
- Venous Thromboembolism
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Eliquis in Korean VTE patients based on incidence of adverse events (AEs), serious adverse events (SAEs)
Measured: Approximately 2 years
Patient characteristics that are associated with bleeding among patients taking Eliquis
Patient Characteristics: Age, sex, weight, height, baseline blood pressure, baseline serum creatinine, baseline creatinine clearance, and device insertion history
Measured: Approximately 2 years
Secondary outcomes (2)
Effectiveness of Eliquis in Korean VTE patients based on proportion of patients with no evidence of VTE and occurrence of VTE
For VTE treatment: The proportion of patients with recurrent VTE at 24 weeks will be calculated. The incidence proportion will be estimated
For prevention of recurrent VTE: The proportion of patients with recurrent VTE at 24 weeks, 52 weeks, and 104 weeks, will be calculated. The incidence proportion will be estimated
Measured: Approximately 2 years
Effectiveness of Eliquis in Korean VTE patients based on proportion of patients with no evidence of VTE and occurrence of VTE
For VTE treatment: The proportion of patients with recurrent VTE at 24 weeks will be calculated. The 95% confidence intervals will be estimated
For prevention of recurrent VTE: The proportion of patients with recurrent VTE at 24 weeks, 52 weeks, and 104 weeks, will be calculated. The 95% confidence intervals will be estimated
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study start30 Nov 2015
- Primary completion29 Sep 2017
- Study completion29 Sep 2017
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
- 29 participants (actual)
- Target duration
- 2 Years
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
- NCT02546817
- Sponsor's protocol ID
- CV185-440
- Status last verified
- Oct 2017
- First submitted
- 7 Sep 2015
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eliquis (Apixaban) Regulatory Postmarketing Surveillance In Real World Practice (rPMS) For Venous Thromboembolism (VTE) Treatment And Prevention Of Recurrent VTE
- ClinicalTrials.gov ID
- NCT02546817
- Acronym / sponsor ID
- CV185-440
- Conditions
- Venous Thromboembolism
- Keywords
- Treatment, Tx, Prevent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2015 (actual)
- Primary completion
- 29 Sep 2017 (actual)
- Study completion
- 29 Sep 2017 (actual)
- First posted
- 11 Sep 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.
To assess the real-world safety/effectiveness of Eliquis in Korean venous thromboembolism (VTE) patients and patient characteristics that are associated with bleeding among patients taking Eliquis. To identify factors that might be associated with the safety and effectiveness profile in Korean VTE patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult (≥19 years of age) patients who are initiating treatment with Eliquis for the treatment of VTE or prevention of recurrent VTE for the first time
Key inclusion criteria (1 listed)
- Adult (≥19 years of age) patients who are initiating treatment with Eliquis for the treatment of VTE or prevention of recurrent VTE for the first time in accordance with the Korean package insert will be enrolled in the study
Key exclusion criteria (22 listed)
- Patients with prior treatment with Eliquis before enrollment in this study
- Patients receiving Eliquis treatment for an indication not approved indication in Korea
- Patients meeting any of the following criteria will not be included in the study:
- Clinically significant active bleeding
- Hepatic disease associated with coagulopathy and clinically relevant bleeding risk
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
Safety of Eliquis in Korean VTE patients based on incidence of adverse events (AEs), serious adverse events (SAEs)
Time frame: Approximately 2 years
Patient characteristics that are associated with bleeding among patients taking Eliquis
Time frame: Approximately 2 years
Patient Characteristics: Age, sex, weight, height, baseline blood pressure, baseline serum creatinine, baseline creatinine clearance, and device insertion history
2 secondary outcomes
Effectiveness of Eliquis in Korean VTE patients based on proportion of patients with no evidence of VTE and occurrence of VTE
Time frame: Approximately 2 years
Effectiveness of Eliquis in Korean VTE patients based on proportion of patients with no evidence of VTE and occurrence of VTE
Time frame: Approximately 2 years
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 31 Oct 2017.
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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 1 inclusion and 22 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 31 Oct 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 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?
Safety of Eliquis in Korean VTE patients based on incidence of adverse events (AEs), serious adverse events (SAEs) (time frame: Approximately 2 years). The study lists 2 primary outcomes in all. 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 31 Oct 2017.