Venous Thromboembolism (VTE) Treatment Study in Japanese Deep Vein Thrombosis (DVT) Patients
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01516840 |
Recruitment Status
:
Completed
First Posted
: January 25, 2012
Last Update Posted
: January 18, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Deep Vein Thrombosis | Drug: Rivaroxaban (Xarelto, BAY59-7939) Drug: Unfractionated heparin Drug: Warfarin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Randomized, Open-label (Double Blind Among Rivaroxaban Groups in the Initial 3 Weeks), Parallel-group, Active-controlled Study of Rivaroxaban in Patients With Acute Symptomatic Deep Vein Thrombosis Without Symptomatic Pulmonary Embolism |
Study Start Date : | March 2012 |
Actual Primary Completion Date : | December 2013 |
Actual Study Completion Date : | January 2014 |
Arm | Intervention/treatment |
---|---|
Experimental: Arm 1 |
Drug: Rivaroxaban (Xarelto, BAY59-7939)
10 mg twice daily for 21 days, followed by 15 mg once daily
|
Experimental: Arm 2 |
Drug: Rivaroxaban (Xarelto, BAY59-7939)
15 mg twice daily for 21 days, followed by 15 mg once daily
|
Active Comparator: Arm 3 |
Drug: Unfractionated heparin
To be adjusted to maintain the activated partial thromboplastin time (aPTT) prolongation (1.5 to 2.5 times the control)
|
Active Comparator: Arm 4 |
Drug: Warfarin
To be adjusted on the basis of prothrombin time-international normalized ratio (PT-INR) values target range (1.5 to 2.5)
|
- 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 ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Men and women >/= 20 years of age in patients with confirmed acute symptomatic proximal deep vein thrombosis (DVT) without symptomatic pulmonary embolism (PE)
Exclusion Criteria:
- Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT
- 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 DVT 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01516840
Japan | |
Toyoake, Aichi, Japan, 470-1192 | |
Sakura, Chiba, Japan, 285-8741 | |
Maebashi, Gunma, Japan, 371-8511 | |
Otake, Hiroshima, Japan, 739-0696 | |
Sapporo, Hokkaido, Japan, 006-8555 | |
Takarazuka, Hyogo, Japan, 665-0827 | |
Kahoku-gun, Ishikawa, Japan, 920-0293 | |
Kanazawa, Ishikawa, Japan, 920-8650 | |
Yokohama, Kanagawa, Japan, 245-8575 | |
Tsu, Mie, Japan, 514-8507 | |
Sasebo, Nagasaki, Japan, 857-8511 | |
Osakasayama, Osaka, Japan, 589-8511 | |
Suita, Osaka, Japan, 565-8565 | |
Bunkyo-ku, Tokyo, Japan, 113-8655 | |
Chuoku, Tokyo, Japan, 104-8560 | |
Itabashi-ku, Tokyo, Japan, 173-8610 | |
Meguro-ku, Tokyo, Japan, 152-8902 | |
Shinagawa, Tokyo, Japan, 141-8625 | |
Shinjuku-ku, Tokyo, Japan, 162-8655 | |
Aomori, Japan, 030-8553 | |
Fukuoka, Japan, 810-0001 | |
Kumamoto, Japan, 862-8505 | |
Niigata, Japan, 951-8520 | |
Okayama, Japan, 701-1192 | |
Osaka, Japan, 530-8480 | |
Osaka, Japan, 537-8511 | |
Shizuoka, Japan, 424-8636 | |
Tokushima, Japan, 770-8503 | |
Wakayama, Japan, 640-8158 |
Study Director: | Bayer Study Director | Bayer |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Bayer |
ClinicalTrials.gov Identifier: | NCT01516840 History of Changes |
Other Study ID Numbers: |
14568 |
First Posted: | January 25, 2012 Key Record Dates |
Last Update Posted: | January 18, 2017 |
Last Verified: | January 2017 |
Keywords provided by Bayer:
acute symptomatic deep vein thrombosis |
Additional relevant MeSH terms:
Thrombosis Venous Thromboembolism Venous Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Thromboembolism Calcium heparin Heparin Warfarin |
Rivaroxaban Anticoagulants Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Factor Xa Inhibitors Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors |