Venous Thromboembolism (VTE) Treatment Study in Japanese Deep Vein Thrombosis (DVT) Patients
This study is ongoing, but not recruiting participants.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01516840
First received: January 20, 2012
Last updated: February 26, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Deep Vein Thrombosis |
Drug: Rivaroxaban (Xarelto, BAY59-7939) Drug: Unfractionated heparin Drug: Warfarin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- Number of participants with newly onset of symptomatic venous thromboembolism (VTE) [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
- Number of clinically relevant bleedings [ Time Frame: Up to 2 days after last dose ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Number of participants with improvement in thrombotic burden [ Time Frame: At week 3 ] [ Designated as safety issue: No ]
- Number of participants with deterioration in thrombotic burden [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
- Number of participants with the composite of newly onset of symptomatic VTE or asymptomatic deterioration of thrombus [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
| Enrollment: | 60 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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)
|
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.
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01516840
Locations
| 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, 537-8511 | |
| Osaka, Japan, 530-8480 | |
| Shizuoka, Japan, 424-8636 | |
| Tokushima, Japan, 770-8503 | |
| Wakayama, Japan, 640-8158 | |
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Head Medical Development Japan, Bayer Yakuhin Ltd. |
| ClinicalTrials.gov Identifier: | NCT01516840 History of Changes |
| Other Study ID Numbers: | 14568 |
| Study First Received: | January 20, 2012 |
| Last Updated: | February 26, 2013 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Keywords provided by Bayer:
|
acute symptomatic deep vein thrombosis |
Additional relevant MeSH terms:
|
Thrombosis Venous Thrombosis Venous Thromboembolism Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Thromboembolism Calcium heparin Heparin |
Warfarin Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 22, 2013