Back to resultsVenous Thromboembolism (VTE) Treatment Study in Japanese Deep Vein Thrombosis (DVT) Patients
Primary Purpose
Deep Vein Thrombosis
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Rivaroxaban (Xarelto, BAY59-7939)
Rivaroxaban (Xarelto, BAY59-7939)
Unfractionated heparin
Warfarin
Sponsored by
About this trial
This is an interventional treatment trial for Deep Vein Thrombosis focused on measuring acute symptomatic deep vein thrombosis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Active Comparator
Arm Label
Arm 1
Arm 2
Arm 3
Arm 4
Arm Description
Outcomes
Primary Outcome Measures
Number of participants with newly onset of symptomatic venous thromboembolism (VTE)
Number of clinically relevant bleedings
Secondary Outcome Measures
Number of participants with improvement in thrombotic burden
Number of participants with deterioration in thrombotic burden
Number of participants with the composite of newly onset of symptomatic VTE or asymptomatic deterioration of thrombus
Full Information
NCT ID
NCT01516840
First Posted
January 20, 2012
Last Updated
January 17, 2017
Sponsor
Bayer
Collaborators
Janssen Scientific Affairs, LLC
1. Study Identification
Unique Protocol Identification Number
NCT01516840
Brief Title
Venous Thromboembolism (VTE) Treatment Study in Japanese Deep Vein Thrombosis (DVT) Patients
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 Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
Collaborators
Janssen Scientific Affairs, LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Vein Thrombosis
Keywords
acute symptomatic deep vein thrombosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Experimental
Arm Title
Arm 3
Arm Type
Active Comparator
Arm Title
Arm 4
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban (Xarelto, BAY59-7939)
Intervention Description
10 mg twice daily for 21 days, followed by 15 mg once daily
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban (Xarelto, BAY59-7939)
Intervention Description
15 mg twice daily for 21 days, followed by 15 mg once daily
Intervention Type
Drug
Intervention Name(s)
Unfractionated heparin
Intervention Description
To be adjusted to maintain the activated partial thromboplastin time (aPTT) prolongation (1.5 to 2.5 times the control)
Intervention Type
Drug
Intervention Name(s)
Warfarin
Intervention Description
To be adjusted on the basis of prothrombin time-international normalized ratio (PT-INR) values target range (1.5 to 2.5)
Primary Outcome Measure Information:
Title
Number of participants with newly onset of symptomatic venous thromboembolism (VTE)
Time Frame
Up to 12 months
Title
Number of clinically relevant bleedings
Time Frame
Up to 2 days after last dose
Secondary Outcome Measure Information:
Title
Number of participants with improvement in thrombotic burden
Time Frame
At week 3
Title
Number of participants with deterioration in thrombotic burden
Time Frame
Up to 12 months
Title
Number of participants with the composite of newly onset of symptomatic VTE or asymptomatic deterioration of thrombus
Time Frame
Up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Toyoake
State/Province
Aichi
ZIP/Postal Code
470-1192
Country
Japan
City
Sakura
State/Province
Chiba
ZIP/Postal Code
285-8741
Country
Japan
City
Maebashi
State/Province
Gunma
ZIP/Postal Code
371-8511
Country
Japan
City
Otake
State/Province
Hiroshima
ZIP/Postal Code
739-0696
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
006-8555
Country
Japan
City
Takarazuka
State/Province
Hyogo
ZIP/Postal Code
665-0827
Country
Japan
City
Kahoku-gun
State/Province
Ishikawa
ZIP/Postal Code
920-0293
Country
Japan
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8650
Country
Japan
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
245-8575
Country
Japan
City
Tsu
State/Province
Mie
ZIP/Postal Code
514-8507
Country
Japan
City
Sasebo
State/Province
Nagasaki
ZIP/Postal Code
857-8511
Country
Japan
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-8565
Country
Japan
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8655
Country
Japan
City
Chuoku
State/Province
Tokyo
ZIP/Postal Code
104-8560
Country
Japan
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
173-8610
Country
Japan
City
Meguro-ku
State/Province
Tokyo
ZIP/Postal Code
152-8902
Country
Japan
City
Shinagawa
State/Province
Tokyo
ZIP/Postal Code
141-8625
Country
Japan
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-8655
Country
Japan
City
Aomori
ZIP/Postal Code
030-8553
Country
Japan
City
Fukuoka
ZIP/Postal Code
810-0001
Country
Japan
City
Kumamoto
ZIP/Postal Code
862-8505
Country
Japan
City
Niigata
ZIP/Postal Code
951-8520
Country
Japan
City
Okayama
ZIP/Postal Code
701-1192
Country
Japan
City
Osaka
ZIP/Postal Code
530-8480
Country
Japan
City
Osaka
ZIP/Postal Code
537-8511
Country
Japan
City
Shizuoka
ZIP/Postal Code
424-8636
Country
Japan
City
Tokushima
ZIP/Postal Code
770-8503
Country
Japan
City
Wakayama
ZIP/Postal Code
640-8158
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
25851062
Citation
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.
Results Reference
derived
PubMed Identifier
25717286
Citation
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. Erratum In: Thromb J. 2016;14:11.
Results Reference
derived
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Venous Thromboembolism (VTE) Treatment Study in Japanese Deep Vein Thrombosis (DVT) Patients
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