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Venous Thromboembolism (VTE) Treatment Study in Japanese Pulmonary Embolism (PE) Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01516814
Recruitment Status : Completed
First Posted : January 25, 2012
Last Update Posted : January 23, 2017
Janssen Research & Development, LLC
Information provided by (Responsible Party):

Brief Summary:
The objective of this study is to evaluate the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of rivaroxaban in the treatment of pulmonary embolism (PE) and the prevention of the occurrence and the recurrence of deep vein thrombosis (DVT) or PE in Japanese patients with acute symptomatic PE with or without symptomatic DVT.

Condition or disease Intervention/treatment Phase
Pulmonary Embolism Drug: Rivaroxaban (Xarelto, BAY59-7939) Drug: Unfractionated heparin Drug: Warfarin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Open-label, Parallel-group, Active-controlled Study of Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism, With or Without Symptomatic Deep Vein Thrombosis
Study Start Date : February 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Arm 1 Drug: Rivaroxaban (Xarelto, BAY59-7939)
15 mg twice daily for 21 days, followed by 15 mg once daily

Active Comparator: Arm 2 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 3 Drug: Warfarin
To be adjusted on the basis of prothrombin time-international normalized ratio (PT-INR) values target range (1.5 to 2.5)

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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Men and women >/= 20 years of age in patients with confirmed acute symptomatic pulmonary embolism (PE) with or without symptomatic deep vein thrombosis (DVT)

Exclusion Criteria:

  • Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of PE
  • 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 PE 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01516814

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Nagoya, Aichi, Japan, 457-8510
Toyoake, Aichi, Japan, 470-1192
Sakura, Chiba, Japan, 285-8741
Kurume, Fukuoka, Japan, 830-8543
Maebashi, Gunma, Japan, 371-8511
Sapporo, Hokkaido, Japan, 006-8555
Kahoku-gun, Ishikawa, Japan, 920-0293
Kanazawa, Ishikawa, Japan, 920-8650
Yokohama, Kanagawa, Japan, 245-8575
Tsu, Mie, Japan, 514-8507
Matsumoto, Nagano, Japan, 390-8510
Suwa, Nagano, Japan, 392-8510
Osakasayama, Osaka, Japan, 589-8511
Suita, Osaka, Japan, 565-8565
Shimotsuke, Tochigi, Japan, 329-0498
Bunkyo-ku, Tokyo, Japan, 113-8519
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
Chiba, Japan, 260-8677
Kumamoto, Japan, 862-8505
Niigata, Japan, 951-8520
Osaka, Japan, 530-8480
Osaka, Japan, 537-8511
Osaka, Japan, 553-0003
Saga, Japan, 840-8571
Shizuoka, Japan, 424-8636
Sponsors and Collaborators
Janssen Research & Development, LLC
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Study Director: Bayer Study Director Bayer

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Bayer Identifier: NCT01516814     History of Changes
Other Study ID Numbers: 15960
First Posted: January 25, 2012    Key Record Dates
Last Update Posted: January 23, 2017
Last Verified: January 2017
Keywords provided by Bayer:
acute symptomatic pulmonary embolism
Additional relevant MeSH terms:
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Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Calcium heparin
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors