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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01516814
First received: January 20, 2012
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Pulmonary Embolism
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: 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

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: 40
Study Start Date: February 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  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 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
  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: NCT01516814

Locations
Japan
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, 113-8655
Bunkyo-ku, Tokyo, Japan, 113-8519
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, 537-8511
Osaka, Japan, 553-0003
Osaka, Japan, 530-8480
Saga, Japan, 840-8571
Shizuoka, Japan, 424-8636
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01516814     History of Changes
Other Study ID Numbers: 15960
Study First Received: January 20, 2012
Last Updated: October 24, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Bayer:
acute symptomatic pulmonary embolism

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Thrombosis
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 July 20, 2014