Venous Thromboembolism (VTE) Treatment Study in Japanese Deep Vein Thrombosis (DVT) Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01516840
First received: January 20, 2012
Last updated: January 9, 2014
Last verified: January 2014
  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
Study Completion Date: December 2013
Primary Completion Date: December 2013 (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
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, see Learn About Clinical Studies.

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: Bayer
ClinicalTrials.gov Identifier: NCT01516840     History of Changes
Other Study ID Numbers: 14568
Study First Received: January 20, 2012
Last Updated: January 9, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Bayer:
acute symptomatic deep vein thrombosis

Additional relevant MeSH terms:
Thrombosis
Venous Thromboembolism
Venous Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Thromboembolism
Vascular Diseases
Calcium heparin
Heparin
Rivaroxaban
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014