Pulmonary EmbolismPhase 3NCT01516814
Venous Thromboembolism (VTE) Treatment Study in Japanese Pulmonary Embolism (PE) Patients
A Phase 3 study testing Rivaroxaban (Xarelto, BAY59-7939), Unfractionated heparin and Warfarin in people with Pulmonary Embolism, run by Bayer at 31 sites in Japan.
Trial summary
The objective of this study is to evaluate the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of rivaroxaban in the treatment of pulmonary embolism (PE) and the prevention of the occurrence and the recurrence of deep vein thrombosis (DVT) or PE in Japanese patients with acute symptomatic PE with or… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Rivaroxaban (Xarelto, BAY59-7939), Unfractionated heparin and Warfarin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 31 sitesJapan
- Study dates
- Feb 2012to Nov 2013
- 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
- Men and women >/= 20 years of age in patients with confirmed acute symptomatic pulmonary embolism (PE) with or without symptomatic deep vein thrombosis (DVT)
Who cannot join
- Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of PE
- More than 48 hours pre-randomization treatment with therapeutic dosages of anti-coagulant treatment or more than a single dose of warfarin from the onset of the current episode of PE to randomization
- Calculated creatinine clearance (CLCR) < 30 mL/min
- Subjects with hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk
- Active bleeding or high risk for bleeding contraindicating treatment with unfractioned Heparin (UFH) or warfarin
- Systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
Japan31 sites
Study site
Aomori, Aomori, 030-8553
Study site
Bunkyo-ku, Tokyo, 113-8519
Study site
Bunkyo-ku, Tokyo, 113-8655
Study site
Chiba, Chiba, 260-8677
Study site
Chuoku, Tokyo, 104-8560
Study site
Kahoku-gun, Ishikawa-ken, 920-0293
Study site
Kanazawa, Ishikawa-ken, 920-8650
Study site
Kumamoto, Kumamoto, 862-8505
Study site
Kurume, Fukuoka, 830-8543
Study site
Maebashi, Gunma, 371-8511
Study site
Matsumoto, Nagano, 390-8510
Study site
Meguro-ku, Tokyo, 152-8902
Study site
Nagoya, Aichi-ken, 457-8510
Study site
Niigata, Niigata, 951-8520
Study site
Osaka, Osaka, 530-8480
Study site
Osaka, Osaka, 537-8511
Study site
Osaka, Osaka, 553-0003
Study site
Saga, Saga-ken, 840-8571
Study site
Sakura, Chiba, 285-8741
Study site
Sapporo, Hokkaido, 006-8555
Study site
Sayama, Osaka, 589-8511
Study site
Shimotsuke, Tochigi, 329-0498
Study site
Shinagawa, Tokyo, 141-8625
Study site
Shinjuku-ku, Tokyo, 162-8655
Study site
Shizuoka, Shizuoka, 424-8636
Study site
Suita, Osaka, 565-8565
Study site
Suwa, Nagano, 392-8510
Study site
tabashi City, Tokyo, 173-8610
Study site
Toyoake, Aichi-ken, 470-1192
Study site
Tsu, Mie-ken, 514-8507
Study site
Yokohama, Kanagawa, 245-8575
About this study
Official title: Randomized, Open-label, Parallel-group, Active-controlled Study of Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism, With or Without Symptomatic Deep Vein Thrombosis
The objective of this study is to evaluate the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of rivaroxaban in the treatment of pulmonary embolism (PE) and the prevention of the occurrence and the recurrence of deep vein thrombosis (DVT) or PE in Japanese patients with acute symptomatic PE with or without symptomatic DVT.
- Conditions
- Pulmonary Embolism
- Being tested
- Rivaroxaban (Xarelto, BAY59-7939), Unfractionated heparin, Warfarin
- Keywords
- acute symptomatic pulmonary embolism
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban (Xarelto, BAY59-7939)Drug
15 mg twice daily for 21 days, followed by 15 mg once daily
Unfractionated heparinDrug
To be adjusted to maintain the activated partial thromboplastin time (aPTT) prolongation (1.5 to 2.5 times the control)
WarfarinDrug
To be adjusted on the basis of prothrombin time-international normalized ratio (PT-INR) values target range (1.5 to 2.5)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939) |
| Arm 2 | Active comparator | Not described Receives: Drug: Unfractionated heparin |
| Arm 3 | Active comparator | Not described Receives: Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with newly onset of symptomatic venous thromboembolism (VTE)
Measured: Up to 12 months
Number of clinically relevant bleedings
Measured: Up to 2 days after last dose
Secondary outcomes (3)
Number of participants with improvement in thrombotic burden
Measured: At week 3
Number of participants with deterioration in thrombotic burden
Measured: Up to 12 months
Number of participants with the composite of newly onset of symptomatic VTE or asymptomatic deterioration of thrombus
Measured: Up 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 posted25 Jan 2012 (estimated)
- Study startFeb 2012
- Primary completionOct 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT01516814
- Sponsor's protocol ID
- 15960
- Status last verified
- Jan 2017
- First submitted
- 20 Jan 2012
- Last updated
- 23 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Matsuo H, Prins M, Lensing AW, Fujinuma EW, Miyamoto Y, Kajikawa M. Shortened length of hospital stay with rivaroxaban in patients with symptomatic venous thromboembolism in Japan: the J-EINSTEIN pulmonary embolism and deep vein thrombosis program. Curr Med Res Opin. 2015 Jun;31(6):1057-61. doi: 10.1185/03007995.2015.1037728. Epub 2015 May 11.
PubMed 25851062Yamada N, Hirayama A, Maeda H, Sakagami S, Shikata H, Prins MH, Lensing AW, Kato M, Onuma J, Miyamoto Y, Iekushi K, Kajikawa M. Oral rivaroxaban for Japanese patients with symptomatic venous thromboembolism - the J-EINSTEIN DVT and PE program. Thromb J. 2015 Jan 17;13:2. doi: 10.1186/s12959-015-0035-3. eCollection 2015.
PubMed 25717286
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
- Randomized, Open-label, Parallel-group, Active-controlled Study of Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism, With or Without Symptomatic Deep Vein Thrombosis
- ClinicalTrials.gov ID
- NCT01516814
- Acronym / sponsor ID
- 15960
- Conditions
- Pulmonary Embolism
- Keywords
- acute symptomatic pulmonary embolism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Study start
- Feb 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 25 Jan 2012 (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 study is to evaluate the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of rivaroxaban in the treatment of pulmonary embolism (PE) and the prevention of the occurrence and the recurrence of deep vein thrombosis (DVT) or PE in Japanese patients with acute symptomatic PE with or without symptomatic DVT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Rivaroxaban (Xarelto, BAY59-7939) |
| Arm 2 | Active comparator | Drug: Unfractionated heparin |
| Arm 3 | Active comparator | Drug: Warfarin |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women >/= 20 years of age in patients with confirmed acute symptomatic pulmonary embolism (PE) with or without symptomatic deep vein thrombosis (DVT)
Key exclusion criteria (6 listed)
- Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of PE
- More than 48 hours pre-randomization treatment with therapeutic dosages of anti-coagulant treatment or more than a single dose of warfarin from the onset of the current episode of PE to randomization
- Calculated creatinine clearance (CLCR) < 30 mL/min
- Subjects with hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk
- Active bleeding or high risk for bleeding contraindicating treatment with unfractioned Heparin (UFH) or warfarin
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)15 mg twice daily for 21 days, followed by 15 mg once daily | Drug | Arm 1 |
| Unfractionated heparinTo be adjusted to maintain the activated partial thromboplastin time (aPTT) prolongation (1.5 to 2.5 times the control) | Drug | Arm 2 |
| WarfarinTo be adjusted on the basis of prothrombin time-international normalized ratio (PT-INR) values target range (1.5 to 2.5) | Drug | Arm 3 |
Primary outcome
Number of participants with newly onset of symptomatic venous thromboembolism (VTE)
Time frame: Up to 12 months
Number of clinically relevant bleedings
Time frame: Up to 2 days after last dose
3 secondary outcomes
Number of participants with improvement in thrombotic burden
Time frame: At week 3
Number of participants with deterioration in thrombotic burden
Time frame: Up to 12 months
Number of participants with the composite of newly onset of symptomatic VTE or asymptomatic deterioration of thrombus
Time frame: Up 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 23 Jan 2017.
- Derived from this study: PubMed 25851062Matsuo H, Prins M, Lensing AW, Fujinuma EW, Miyamoto Y, Kajikawa M. Shortened length of hospital stay with rivaroxaban in patients with symptomatic venous thromboembolism in Japan: the J-EINSTEIN pulmonary embolism and deep vein thrombosis program. Curr Med Res Opin. 2015 Jun;31(6):1057-61. doi: 10.1185/03007995.2015.1037728. Epub 2015 May 11.
- Derived from this study: PubMed 25717286Yamada N, Hirayama A, Maeda H, Sakagami S, Shikata H, Prins MH, Lensing AW, Kato M, Onuma J, Miyamoto Y, Iekushi K, Kajikawa M. Oral rivaroxaban for Japanese patients with symptomatic venous thromboembolism - the J-EINSTEIN DVT and PE program. Thromb J. 2015 Jan 17;13:2. doi: 10.1186/s12959-015-0035-3. eCollection 2015.
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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
31 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 (Xarelto, BAY59-7939), Unfractionated heparin and Warfarin in people with Pulmonary Embolism, run by Bayer at 31 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 1 inclusion and 6 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 31 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?
Number of participants with newly onset of symptomatic venous thromboembolism (VTE) (time frame: Up to 12 months). 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?
On the ClinicalTrials.gov record for NCT01516814, which also lists 2 linked publications.
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.