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| Name | Class |
|---|---|
| Janssen Scientific Affairs, LLC | INDUSTRY |
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The objective of this study is to evaluate the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of two different dosages of rivaroxaban in the treatment of deep vein thrombosis (DVT) and the prevention of the occurrence and the recurrence of DVT or pulmonary embolism (PE) in Japanese patients with acute symptomatic DVT without symptomatic PE.
The general design of the trial is open label between the Rivaroxaban and the reference arm. However, there are two groups in the Rivaroxaban arm only for the initial 3 weeks. Between these two groups and in this initial period, the study is blinded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Experimental |
| |
| Arm 3 | Active Comparator |
| |
| Arm 4 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939) | Drug | 10 mg twice daily for 21 days, followed by 15 mg once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toyoake | Aichi-ken | 470-1192 | Japan | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25851062 | Derived | 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. | |
| 25717286 |
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| Rivaroxaban (Xarelto, BAY59-7939) | Drug | 15 mg twice daily for 21 days, followed by 15 mg once daily |
|
| Unfractionated heparin | Drug | To be adjusted to maintain the activated partial thromboplastin time (aPTT) prolongation (1.5 to 2.5 times the control) |
|
| Warfarin | Drug | To be adjusted on the basis of prothrombin time-international normalized ratio (PT-INR) values target range (1.5 to 2.5) |
|
| Up to 12 months |
| Aomori |
| Aomori |
| 030-8553 |
| Japan |
| Sakura | Chiba | 285-8741 | Japan |
| Fukuoka | Fukuoka | 810-0001 | Japan |
| Maebashi | Gunma | 371-8511 | Japan |
| Ōtake | Hiroshima | 739-0696 | Japan |
| Sapporo | Hokkaido | 006-8555 | Japan |
| Takarazuka | Hyōgo | 665-0827 | Japan |
| Kahoku-gun | Ishikawa-ken | 920-0293 | Japan |
| Kanazawa | Ishikawa-ken | 920-8650 | Japan |
| Yokohama | Kanagawa | 245-8575 | Japan |
| Kumamoto | Kumamoto | 862-8505 | Japan |
| Tsu | Mie-ken | 514-8507 | Japan |
| Sasebo | Nagasaki | 857-8511 | Japan |
| Niigata | Niigata | 951-8520 | Japan |
| Okayama | Okayama-ken | 701-1192 | Japan |
| Osaka | Osaka | 530-8480 | Japan |
| Osaka | Osaka | 537-8511 | Japan |
| Sayama | Osaka | 589-8511 | Japan |
| Suita | Osaka | 565-8565 | Japan |
| Shizuoka | Shizuoka | 424-8636 | Japan |
| Tokushima | Tokushima | 770-8503 | Japan |
| Bunkyo-ku | Tokyo | 113-8655 | Japan |
| Chuoku | Tokyo | 104-8560 | Japan |
| Itabashi-ku | Tokyo | 173-8610 | Japan |
| Meguro-ku | Tokyo | 152-8902 | Japan |
| Shinagawa | Tokyo | 141-8625 | Japan |
| Shinjuku-ku | Tokyo | 162-8655 | Japan |
| Wakayama | Wakayama | 640-8158 | Japan |
| Yamada 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. |
| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| D006493 | Heparin |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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