Deep Vein Thrombosis (DVT)XALIA LEANCT02210819
Treatment of Venous Thromboembolism (VTE) With Either Rivaroxaban or Current Standard of Care Therapy
An observational study of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE), run by Bayer at 21 sites in 21 countries.
Trial summary
Following the findings of the clinical trials in drug development, this global non-interventional cohort field study will investigate rivaroxaban under clinical practice conditions in comparison with current standard of care for patients with acute venous thoromboembolism (VTE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE)
- What is being tested?
- Rivaroxaban (Xarelto, BAY59-7939) and Recommended VTE pharmacological treatments according to international guidelines
- How many people
- 1,987 participants
- Where
- 21 sitesin 21 countries
- Study dates
- 27 Jun 2014to 20 Jan 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: In- and outpatients in sites participating in the study.
Who may be able to join
- Female or male patients, who are at >=18 years
- Diagnosis of acute DVT and/or PE, objectively confirmed
- Indication for anticoagulation therapy for at least 12 weeks
- Willing to participate in this study and available for follow-up
Who cannot join
- Exclusion criteria must be read in conjunction with the local product information.
Trial locations and contacts
21 sites in 21 countries.
21 sites in 21 countries
About this study
Official title: XALIA LEA- Xarelto for Long-term and Initial Anticoagulation in Venous Thromboembolism (VTE) in Latin America, EMEA and Asia
Following the findings of the clinical trials in drug development, this global non-interventional cohort field study will investigate rivaroxaban under clinical practice conditions in comparison with current standard of care for patients with acute venous thoromboembolism (VTE).
The main goal is to analyze long-term safety in the use of rivaroxaban in the treatment of acute VTE in routine clinical practice.
- Being tested
- Rivaroxaban (Xarelto, BAY59-7939), Recommended VTE pharmacological treatments according to international guidelines
- Keywords
- Thromboembolism, Embolism and Thrombosis, Vascular Diseases, Cardiovascular Diseases, Thrombosis
- Medical subject headings
- Venous Thrombosis, Pulmonary Embolism, Thromboembolism, Embolism and Thrombosis, Vascular Diseases, Cardiovascular Diseases, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban (Xarelto, BAY59-7939)Drug
Cohort participants are classified as "rivaroxaban" patient, if the patient receives initial rivaroxaban VTE treatment. Dosing according to daily clinical routine
Recommended VTE pharmacological treatments according to international guidelinesDrug
Cohort participants are classified as "Standard of care" patients, if the patient receives recommended VTE pharmacological treatments according to international guidelines, e.g. unfractionated heparin, LMWH, fondaparinux, VKA, if these are also approved pharmacological treatments for VTE in the respective country. Dosing according to daily clinical routine.
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban | Patients who will be treated for an acute venous thromboembolism (VTE) with rivaroxaban. Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939) | |
| Standard of care | Patients who will be treated for an acute venous thromboembolism (VTE) with current standard of care. Receives: Drug: Recommended VTE pharmacological treatments according to international guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of major bleedings defined as overt bleeding
Major bleedings defined as overt bleeding are associated with: A fall in hemoglobin of ≥2 g/dL; or a transfusion of ≥2 units of packed red blood cells or whole blood; or occurrence at a critical site
Measured: Up to 2 years
Number of patients with symptomatic recurrent venous thromboembolic events
Measured: Up to 2 years
All cause mortality
Measured: Up to 2 years
Secondary outcomes (3)
Number of adverse cardiovascular events
Number of cardiovascular events will be used for descriptive statistics to summarize safety variables.
Measured: Up to 2 years
Number of patients with other symptomatic thromboembolic events
Measured: Up to 2 years
Treatment satisfaction (patient reported outcomes)
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study start27 Jun 2014
- Primary completion3 Nov 2016
- Study completion20 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Vein Thrombosis (DVT)Studies of the same condition, open and under way.
- More trials run by BayerThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,987 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02210819
- Sponsor's protocol ID
- 17237
- Other IDs
- XA1402
- Acronym
- XALIA LEA
- Status last verified
- Aug 2019
- First submitted
- 20 May 2014
- Last updated
- 29 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- XALIA LEA- Xarelto for Long-term and Initial Anticoagulation in Venous Thromboembolism (VTE) in Latin America, EMEA and Asia
- ClinicalTrials.gov ID
- NCT02210819
- Acronym / sponsor ID
- XALIA LEA / 17237
- Keywords
- Thromboembolism, Embolism and Thrombosis, Vascular Diseases, Cardiovascular Diseases, Thrombosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,987 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Study start
- 27 Jun 2014 (actual)
- Primary completion
- 3 Nov 2016 (actual)
- Study completion
- 20 Jan 2017 (actual)
- First posted
- 7 Aug 2014 (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.
Following the findings of the clinical trials in drug development, this global non-interventional cohort field study will investigate rivaroxaban under clinical practice conditions in comparison with current standard of care for patients with acute venous thoromboembolism (VTE).
The main goal is to analyze long-term safety in the use of rivaroxaban in the treatment of acute VTE in routine clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban | – | Drug: Rivaroxaban (Xarelto, BAY59-7939)Patients who will be treated for an acute venous thromboembolism (VTE) with rivaroxaban. |
| Standard of care | – | Drug: Recommended VTE pharmacological treatments according to international guidelinesPatients who will be treated for an acute venous thromboembolism (VTE) with current standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In- and outpatients in sites participating in the study.
Key inclusion criteria (4 listed)
- Female or male patients, who are at >=18 years
- Diagnosis of acute DVT and/or PE, objectively confirmed
- Indication for anticoagulation therapy for at least 12 weeks
- Willing to participate in this study and available for follow-up
Key exclusion criteria (1 listed)
- Exclusion criteria must be read in conjunction with the local product information.
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 |
|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939)Cohort participants are classified as "rivaroxaban" patient, if the patient receives initial rivaroxaban VTE treatment. Dosing according to daily clinical routine | Drug | Rivaroxaban |
| Recommended VTE pharmacological treatments according to international guidelinesCohort participants are classified as "Standard of care" patients, if the patient receives recommended VTE pharmacological treatments according to international guidelines, e.g. unfractionated heparin, LMWH, fondaparinux, VKA, if these are also approved pharmacological treatments for VTE in the respective country. Dosing according to daily clinical routine. | Drug | Standard of care |
Primary outcome
Number of major bleedings defined as overt bleeding
Time frame: Up to 2 years
Major bleedings defined as overt bleeding are associated with: A fall in hemoglobin of ≥2 g/dL; or a transfusion of ≥2 units of packed red blood cells or whole blood; or occurrence at a critical site
Number of patients with symptomatic recurrent venous thromboembolic events
Time frame: Up to 2 years
All cause mortality
Time frame: Up to 2 years
3 secondary outcomes
Number of adverse cardiovascular events
Time frame: Up to 2 years
Number of patients with other symptomatic thromboembolic events
Time frame: Up to 2 years
Treatment satisfaction (patient reported outcomes)
Time frame: Up to 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 29 Aug 2019.
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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.
Bayer Study Director study director
Bayer
21 sites in 21 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE), run by Bayer at 21 sites in 21 countries.
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 4 inclusion and 1 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 29 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Algeria, Egypt, Indonesia, Jordan, Kazakhstan and 16 more countries. 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 major bleedings defined as overt bleeding (time frame: Up to 2 years). The study lists 3 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 29 Aug 2019.