Venous Thromboembolism (VTE) Treatment Study in Japanese Deep Vein Thrombosis (DVT) Patients - Full Text View

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:

MedlinePlus related topics: Blood Clots Blood Thinners Deep Vein Thrombosis Pulmonary Embolism

Drug Information available for: Warfarin Rivaroxaban

U.S. FDA Resources

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 (Adult, Senior)
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, 530-8480

Osaka, Japan, 537-8511

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:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


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 Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Thromboembolism Calcium heparin Heparin Rivaroxaban	Warfarin Anticoagulants Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Factor Xa Inhibitors Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 23, 2016