Venous Thromboembolism (VTE) Treatment Study in Japanese Pulmonary Embolism (PE) Patients
Randomized, Open-label, Parallel-group, Active-controlled Study of Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism, With or Without Symptomatic Deep Vein Thrombosis
1 other identifier
interventional
40
1 country
31
Brief 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 without symptomatic DVT.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2012
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2012
CompletedFirst Posted
Study publicly available on registry
January 25, 2012
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedJanuary 23, 2017
January 1, 2017
1.7 years
January 20, 2012
January 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of participants with newly onset of symptomatic venous thromboembolism (VTE)
Up to 12 months
Number of clinically relevant bleedings
Up to 2 days after last dose
Secondary Outcomes (3)
Number of participants with improvement in thrombotic burden
At week 3
Number of participants with deterioration in thrombotic burden
Up to 12 months
Number of participants with the composite of newly onset of symptomatic VTE or asymptomatic deterioration of thrombus
Up to 12 months
Study Arms (3)
Arm 1
EXPERIMENTALArm 2
ACTIVE COMPARATORArm 3
ACTIVE COMPARATORInterventions
15 mg twice daily for 21 days, followed by 15 mg once daily
To be adjusted to maintain the activated partial thromboplastin time (aPTT) prolongation (1.5 to 2.5 times the control)
To be adjusted on the basis of prothrombin time-international normalized ratio (PT-INR) values target range (1.5 to 2.5)
Eligibility Criteria
You may qualify if:
- Men and women \>/= 20 years of age in patients with confirmed acute symptomatic pulmonary embolism (PE) with or without symptomatic deep vein thrombosis (DVT)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
- Janssen Research & Development, LLCcollaborator
Study Sites (31)
Unknown Facility
Nagoya, Aichi-ken, 457-8510, Japan
Unknown Facility
Toyoake, Aichi-ken, 470-1192, Japan
Unknown Facility
Aomori, Aomori, 030-8553, Japan
Unknown Facility
Chiba, Chiba, 260-8677, Japan
Unknown Facility
Sakura, Chiba, 285-8741, Japan
Unknown Facility
Kurume, Fukuoka, 830-8543, Japan
Unknown Facility
Maebashi, Gunma, 371-8511, Japan
Unknown Facility
Sapporo, Hokkaido, 006-8555, Japan
Unknown Facility
Kahoku-gun, Ishikawa-ken, 920-0293, Japan
Unknown Facility
Kanazawa, Ishikawa-ken, 920-8650, Japan
Unknown Facility
Yokohama, Kanagawa, 245-8575, Japan
Unknown Facility
Kumamoto, Kumamoto, 862-8505, Japan
Unknown Facility
Tsu, Mie-ken, 514-8507, Japan
Unknown Facility
Matsumoto, Nagano, 390-8510, Japan
Unknown Facility
Suwa, Nagano, 392-8510, Japan
Unknown Facility
Niigata, Niigata, 951-8520, Japan
Unknown Facility
Osaka, Osaka, 530-8480, Japan
Unknown Facility
Osaka, Osaka, 537-8511, Japan
Unknown Facility
Osaka, Osaka, 553-0003, Japan
Unknown Facility
Sayama, Osaka, 589-8511, Japan
Unknown Facility
Suita, Osaka, 565-8565, Japan
Unknown Facility
Saga, Saga-ken, 840-8571, Japan
Unknown Facility
Shizuoka, Shizuoka, 424-8636, Japan
Unknown Facility
Shimotsuke, Tochigi, 329-0498, Japan
Unknown Facility
Bunkyo-ku, Tokyo, 113-8519, Japan
Unknown Facility
Bunkyo-ku, Tokyo, 113-8655, Japan
Unknown Facility
Chuoku, Tokyo, 104-8560, Japan
Unknown Facility
Itabashi-ku, Tokyo, 173-8610, Japan
Unknown Facility
Meguro-ku, Tokyo, 152-8902, Japan
Unknown Facility
Shinagawa, Tokyo, 141-8625, Japan
Unknown Facility
Shinjuku-ku, Tokyo, 162-8655, Japan
Related Publications (2)
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.
PMID: 25851062DERIVEDYamada 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.
PMID: 25717286DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2012
First Posted
January 25, 2012
Study Start
February 1, 2012
Primary Completion
October 1, 2013
Study Completion
November 1, 2013
Last Updated
January 23, 2017
Record last verified: 2017-01