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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Deep Vein Thrombosis	Drug: Rivaroxaban (Xarelto, BAY59-7939); Drug: Unfractionated heparin; Drug: Warfarin	Phase 3

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.

Study Design

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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

Arms and Interventions

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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)

Outcome Measures

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Primary Outcome Measures :

1. Number of participants with newly onset of symptomatic venous thromboembolism (VTE) [ Time Frame: Up to 12 months ]
2. Number of clinically relevant bleedings [ Time Frame: Up to 2 days after last dose ]

Secondary Outcome Measures :

1. Number of participants with improvement in thrombotic burden [ Time Frame: At week 3 ]
2. Number of participants with deterioration in thrombotic burden [ Time Frame: Up to 12 months ]
3. Number of participants with the composite of newly onset of symptomatic VTE or asymptomatic deterioration of thrombus [ Time Frame: Up to 12 months ]

Eligibility Criteria

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Ages Eligible for Study:	20 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Janssen Scientific Affairs, LLC

Investigators

Study Director:	Bayer Study Director	Bayer

More Information

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Additional Information:

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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.

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.

Responsible Party:	Bayer
ClinicalTrials.gov Identifier:	NCT01516840 History of Changes
Other Study ID Numbers:	14568
First Posted:	January 25, 2012
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