Venous ThromboembolismNCT01029743
Xarelto Regulatory Post-Marketing Surveillance
An observational study of Venous Thromboembolism, run by Bayer at 1 site in South Korea.
Trial summary
This study is to identify the following problems and questions with respect to the safety and effectiveness of Xarelto in comparison with other pharmacologic agents in the prophylaxis of venous thromboembolism (VTE) in a large sample of patients who undergo elective total hip replacement (THR) or total knee… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- Rivaroxaban (Xarelto, BAY59-7939) and Pharmacologic agents (e.g. LMWH/VKA/Fondaparinux/Aspirin and etc.)
- How many people
- 3,388 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2009to Jan 2016
- 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: Patients who will be treated with rivaroxaban or other pharmacologic agents (e.g. LMWH/VKA/Fondaparinux) to prevent VTE after elective total hip replacement or total knee replacement
Who may be able to join
- Female and male patients >/= 18 years of age who will undergo elective total hip replacement or total knee replacement and receive Xarelto or other pharmacologic standard of care Venous Thromboembolism (VTE) prophylaxis, and who consent to participate in the study
Who cannot join
- Patients with hypersensitivity to any pharmacologic VTE prophylaxis treatment
- Patients with clinically significant active bleeding (e.g., intracranial bleeding, gastrointestinal bleeding)
- Patients with significant hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk
- Pregnant or lactating women
- Patients with hereditary problems of lactose or galactose intolerance (e.g., the Lapp lactase deficiency or glucose-galactose malabsorption)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Xarelto® Regulatory Post-Marketing Surveillance
This study is to identify the following problems and questions with respect to the safety and effectiveness of Xarelto in comparison with other pharmacologic agents in the prophylaxis of venous thromboembolism (VTE) in a large sample of patients who undergo elective total hip replacement (THR) or total knee replacement (TKR) in the real-life conditions in its registered indication(s) as required by Korean Food and Drug Administration (KFDA).
- Known and unknown adverse reactions, especially serious adverse reactions
- Incidence of adverse reactions under the routine drug use
- Factors that may affect the safety of the drug
- Factors that may affect the effectiveness of the drug
- Other safety information related to overuse, drug interaction and laboratory abnormalities
- Other adverse reactions
- Conditions
- Venous Thromboembolism
- Being tested
- Rivaroxaban (Xarelto, BAY59-7939), Pharmacologic agents (e.g. LMWH/VKA/Fondaparinux/Aspirin and etc.)
- Keywords
- TKR (Total Knee Replacement), THR (Total Hip Replacement), VTE (Venous Thromboembolism), LMWH (Low Molecular Weight Heparin), VKA (Vitamin K antagonist)
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban (Xarelto, BAY59-7939)Drug
Daily dose, a treatment duration of 5 weeks for patients undergoing major hip surgery and a treatment duration of 2 weeks for patients undergoing major knee surgery are recommended
Pharmacologic agents (e.g. LMWH/VKA/Fondaparinux/Aspirin and etc.)Drug
Daily dose, dosage frequency and duration will be decided by physicians
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939) | |
| Group 2 | Not described Receives: Drug: Pharmacologic agents (e.g. LMWH/VKA/Fondaparinux/Aspirin and etc.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event collection
Measured: From the start of signed consent to 4 weeks after discharge
Secondary outcomes (1)
Duration of treatment
Measured: Whole treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionMar 2015
- Study completionJan 2016
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 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
- 3,388 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
- NCT01029743
- Sponsor's protocol ID
- 14793
- Other IDs
- XA0910KR
- Status last verified
- Jan 2017
- First submitted
- 9 Dec 2009
- Last updated
- 23 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xarelto® Regulatory Post-Marketing Surveillance
- ClinicalTrials.gov ID
- NCT01029743
- Acronym / sponsor ID
- 14793
- Conditions
- Venous Thromboembolism
- Keywords
- TKR (Total Knee Replacement), THR (Total Hip Replacement), VTE (Venous Thromboembolism), LMWH (Low Molecular Weight Heparin), VKA (Vitamin K antagonist)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,388 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Study start
- Dec 2009
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 10 Dec 2009 (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.
This study is to identify the following problems and questions with respect to the safety and effectiveness of Xarelto in comparison with other pharmacologic agents in the prophylaxis of venous thromboembolism (VTE) in a large sample of patients who undergo elective total hip replacement (THR) or total knee replacement (TKR) in the real-life conditions in its registered indication(s) as required by Korean Food and Drug Administration (KFDA).
- Known and unknown adverse reactions, especially serious adverse reactions
- Incidence of adverse reactions under the routine drug use
- Factors that may affect the safety of the drug
- Factors that may affect the effectiveness of the drug
- Other safety information related to overuse, drug interaction and laboratory abnormalities
- Other adverse reactions
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Rivaroxaban (Xarelto, BAY59-7939) |
| Group 2 | – | Drug: Pharmacologic agents (e.g. LMWH/VKA/Fondaparinux/Aspirin and etc.) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will be treated with rivaroxaban or other pharmacologic agents (e.g. LMWH/VKA/Fondaparinux) to prevent VTE after elective total hip replacement or total knee replacement
Key inclusion criteria (1 listed)
- Female and male patients >/= 18 years of age who will undergo elective total hip replacement or total knee replacement and receive Xarelto or other pharmacologic standard of care Venous Thromboembolism (VTE) prophylaxis, and who consent to participate in the study
Key exclusion criteria (5 listed)
- Patients with hypersensitivity to any pharmacologic VTE prophylaxis treatment
- Patients with clinically significant active bleeding (e.g., intracranial bleeding, gastrointestinal bleeding)
- Patients with significant hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk
- Pregnant or lactating women
- Patients with hereditary problems of lactose or galactose intolerance (e.g., the Lapp lactase deficiency or glucose-galactose malabsorption)
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)Daily dose, a treatment duration of 5 weeks for patients undergoing major hip surgery and a treatment duration of 2 weeks for patients undergoing major knee surgery are recommended | Drug | Group 1 |
| Pharmacologic agents (e.g. LMWH/VKA/Fondaparinux/Aspirin and etc.)Daily dose, dosage frequency and duration will be decided by physicians | Drug | Group 2 |
Primary outcome
Adverse event collection
Time frame: From the start of signed consent to 4 weeks after discharge
1 secondary outcome
Duration of treatment
Time frame: Whole treatment period
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 23 Jan 2017.
Related trials for Venous Thromboembolism
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
Recruiting
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Venous Thromboembolism, Deep Venous Thrombosis
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
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 Bayer 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 5 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 23 Jan 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?
Adverse event collection (time frame: From the start of signed consent to 4 weeks after discharge). 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 23 Jan 2017.