Venous ThromboembolismPhase 3NCT01206972
Dose-confirmatory Bridging Study in Total Knee Replacement
A Phase 3 study testing Rivaroxaban (BAY59-7939) and Enoxaparin in people with Venous Thromboembolism, run by Bayer at 33 sites in Japan.
Trial summary
The objective of this dose-confirmatory bridging study is to investigate the safety and efficacy of rivaroxaban 5 to 10 mg once-daily (od) dosing in the prevention of venous thromboembolism (VTE) in Japanese patients undergoing elective total knee replacement (TKR) and to confirm the extrapolability of global data to… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- Rivaroxaban (BAY59-7939) and Enoxaparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 33 sitesJapan
- Study dates
- Oct 2010to Jun 2011
- Phase
- Phase 3
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients aged 20 years or above
- Patients undergoing elective TKR (the first replacement of the applicable knee joint)
- Patients' written informed consent to participation after receiving detailed verbal and written information on any study specific procedures in advance
Who cannot join
- Planned, staged major orthopedic surgery within 3 months prior to elective TKR or during this study
- History of clinically significant active bleeding (e.g. intracranial bleeding, gastrointestinal bleeding*), or high bleeding risk
- : within 3 months prior to elective TKR for gastrointestinal bleeding
- Subjects with hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk
- Severe impaired renal function (CLCR calculated by Cockcroft-Gault formula: <30 mL/min)
- Conditions prohibiting bilateral venography (e.g. amputation of 1 leg, allergy to contrast media)
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- Ongoing anticoagulant therapy (e.g. warfarin, heparins and Factor Xa inhibitors other than study medication) that cannot be stopped (in the opinion of the investigator/sub investigator)
- Subjects for whom epidural catheters are expected to be left in for longer than 18 hours post-operatively
- Planned intermittent pneumatic compression during treatment period.
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
Japan33 sites
Study site
Adachi City, Tokyo, 121-0064
Study site
Asahikawa, Hokkaido, 078-8237
Study site
Fukuoka, Fukuoka, 813-0017
Study site
Fukuoka, Fukuoka, 819-8551
Study site
Hakodate, Hokkaido, 040-8611
Study site
Hirakata, Osaka, 573-8511
Study site
Iida, Nagano, 395-8505
Study site
Izumi, Osaka, 594-0071
Study site
Izumisano, Osaka, 598-8577
Study site
Kakogawa, Hyōgo, 675-8545
Study site
Kawanuma, Fukushima, 969-6593
Study site
Kishiwada, Osaka, 596-8501
Study site
Kishiwada, Osaka, 596-8522
Study site
Kobe, Hyōgo, 657-0068
Study site
Kōriyama, Fukushima, 963-8501
Study site
Kyoto, Kyoto, 602-8026
Study site
Matsudo, Chiba, 271-8511
Study site
Matsuyama, Ehime, 790-8524
Study site
Nagoya, Aichi-ken, 455-8530
Study site
Nerima-ku, Tokyo, 177-8521
Study site
Nishinomiya, Hyōgo, 663-8501
Study site
Osaka, Osaka, 530-0012
Study site
Osaka, Osaka, 558-8558
Study site
Saga, Saga-ken, 849-8501
Study site
Saitama, Saitama, 336-8522
Study site
Sakai, Osaka, 599-8271
Study site
Sapporo, Hokkaido, 060-8648
Study site
Sasebo, Nagasaki, 857-8575
Study site
Sayama, Osaka, 589-8511
Study site
Takatsuki, Osaka, 569-1192
Study site
Tomigusuku, Okinawa, 901-0243
Study site
Toyama, Toyama, 930-8550
Study site
Tsukuba, Ibaraki, 305-0854
About this study
Official title: Randomized, Double-blind, Parallel-group, Active-controlled, Dose-confirmatory Bridging Study of Rivaroxaban (BAY59-7939) 5 to 10 mg Once-daily Regimen With a Reference Drug of Enoxaparin in the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement
The objective of this dose-confirmatory bridging study is to investigate the safety and efficacy of rivaroxaban 5 to 10 mg once-daily (od) dosing in the prevention of venous thromboembolism (VTE) in Japanese patients undergoing elective total knee replacement (TKR) and to confirm the extrapolability of global data to Japanese patients by comparing with data from overseas phase III study (RECORD 3 - Study 11356) and phase II studies.
- Conditions
- Venous Thromboembolism
- Being tested
- Rivaroxaban (BAY59-7939), Enoxaparin
- Keywords
- venous thromboembolism, prevention, orthopaedic surgery
- 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 (BAY59-7939)Drug
daily dose: 5mg/day (5mg, once daily) for 11 to 12 days (±2 days)
Rivaroxaban (BAY59-7939)Drug
daily dose: 7.5mg/day (7.5mg, once daily) for 11 to 12 days (±2 days)
Rivaroxaban (BAY59-7939)Drug
daily dose: 10mg/day (10mg, once daily) for 11 to 12 days (±2 days)
EnoxaparinDrug
daily dose: 40mg/day (20mg, twice daily) for 10 to 11 days (±2 days)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Rivaroxaban (BAY59-7939) |
| Arm 2 | Experimental | Not described Receives: Drug: Rivaroxaban (BAY59-7939) |
| Arm 3 | Experimental | Not described Receives: Drug: Rivaroxaban (BAY59-7939) |
| Arm 4 | Active comparator | Not described Receives: Drug: Enoxaparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite endpoint of any deep vein thrombosis (proximal and/or distal), non-fatal pulmonary embolism and death from all causes
Measured: up to Day 13 (±2 days)
Treatment-emergent bleeding (major, non-major clinically relevant, other non-major)
Measured: from the first intake of study medication to no later than 2 days after the last intake of study drug
Secondary outcomes (4)
deep vein thrombosis (total, proximal, distal)
Measured: up to Day 13 (±2 days)
symptomatic venous thromboembolism
Measured: up to Day 13 (±2 days)
major venous thromboembolism (proximal deep vein thromboembolism, pulmonary embolism or venous thromboembolism-related death)
Measured: up to Day 13 (±2 days)
symptomatic venous thromboembolism
Measured: within 30 days after stop of treatment with study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionMay 2011
- Study completionJun 2011
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Scientific Affairs, LLC
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01206972
- Sponsor's protocol ID
- 14398
- Status last verified
- Jan 2017
- First submitted
- 20 Sep 2010
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Parallel-group, Active-controlled, Dose-confirmatory Bridging Study of Rivaroxaban (BAY59-7939) 5 to 10 mg Once-daily Regimen With a Reference Drug of Enoxaparin in the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement
- ClinicalTrials.gov ID
- NCT01206972
- Acronym / sponsor ID
- 14398
- Conditions
- Venous Thromboembolism
- Keywords
- venous thromboembolism, prevention, orthopaedic surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Scientific Affairs, LLC
- Study start
- Oct 2010
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 22 Sep 2010 (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 dose-confirmatory bridging study is to investigate the safety and efficacy of rivaroxaban 5 to 10 mg once-daily (od) dosing in the prevention of venous thromboembolism (VTE) in Japanese patients undergoing elective total knee replacement (TKR) and to confirm the extrapolability of global data to Japanese patients by comparing with data from overseas phase III study (RECORD 3 - Study 11356) and phase II studies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Rivaroxaban (BAY59-7939) |
| Arm 2 | Experimental | Drug: Rivaroxaban (BAY59-7939) |
| Arm 3 | Experimental | Drug: Rivaroxaban (BAY59-7939) |
| Arm 4 | Active comparator | Drug: Enoxaparin |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female patients aged 20 years or above
- Patients undergoing elective TKR (the first replacement of the applicable knee joint)
- Patients' written informed consent to participation after receiving detailed verbal and written information on any study specific procedures in advance
Key exclusion criteria (9 listed)
- Planned, staged major orthopedic surgery within 3 months prior to elective TKR or during this study
- History of clinically significant active bleeding (e.g. intracranial bleeding, gastrointestinal bleeding*), or high bleeding risk
- : within 3 months prior to elective TKR for gastrointestinal bleeding
- Subjects with hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk
- Severe impaired renal function (CLCR calculated by Cockcroft-Gault formula: <30 mL/min)
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 (BAY59-7939)daily dose: 5mg/day (5mg, once daily) for 11 to 12 days (±2 days) | Drug | Arm 1 |
| Rivaroxaban (BAY59-7939)daily dose: 7.5mg/day (7.5mg, once daily) for 11 to 12 days (±2 days) | Drug | Arm 2 |
| Rivaroxaban (BAY59-7939)daily dose: 10mg/day (10mg, once daily) for 11 to 12 days (±2 days) | Drug | Arm 3 |
| Enoxaparindaily dose: 40mg/day (20mg, twice daily) for 10 to 11 days (±2 days) | Drug | Arm 4 |
Primary outcome
A composite endpoint of any deep vein thrombosis (proximal and/or distal), non-fatal pulmonary embolism and death from all causes
Time frame: up to Day 13 (±2 days)
Treatment-emergent bleeding (major, non-major clinically relevant, other non-major)
Time frame: from the first intake of study medication to no later than 2 days after the last intake of study drug
4 secondary outcomes
deep vein thrombosis (total, proximal, distal)
Time frame: up to Day 13 (±2 days)
symptomatic venous thromboembolism
Time frame: up to Day 13 (±2 days)
major venous thromboembolism (proximal deep vein thromboembolism, pulmonary embolism or venous thromboembolism-related death)
Time frame: up to Day 13 (±2 days)
symptomatic venous thromboembolism
Time frame: within 30 days after stop of treatment with study drug
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 18 Jan 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.
Bayer Study Director study director
Bayer
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rivaroxaban (BAY59-7939) and Enoxaparin in people with Venous Thromboembolism, run by Bayer at 33 sites in Japan.
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 3 inclusion and 9 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 18 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 33 sites in Japan. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
A composite endpoint of any deep vein thrombosis (proximal and/or distal), non-fatal pulmonary embolism and death from all causes (time frame: up to Day 13 (±2 days)). 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 18 Jan 2017.