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

January 19, 2017 updated by: Bayer

Randomized, Open-label, Parallel-group, Active-controlled Study of Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism, With or Without Symptomatic Deep Vein Thrombosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • 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
    • Aichi
      • Nagoya, Aichi, Japan, 457-8510
      • Toyoake, Aichi, Japan, 470-1192
    • Chiba
      • Sakura, Chiba, Japan, 285-8741
    • Fukuoka
      • Kurume, Fukuoka, Japan, 830-8543
    • Gunma
      • Maebashi, Gunma, Japan, 371-8511
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 006-8555
    • Ishikawa
      • Kahoku-gun, Ishikawa, Japan, 920-0293
      • Kanazawa, Ishikawa, Japan, 920-8650
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 245-8575
    • Mie
      • Tsu, Mie, Japan, 514-8507
    • Nagano
      • Matsumoto, Nagano, Japan, 390-8510
      • Suwa, Nagano, Japan, 392-8510
    • Osaka
      • Osakasayama, Osaka, Japan, 589-8511
      • Suita, Osaka, Japan, 565-8565
    • Tochigi
      • Shimotsuke, Tochigi, Japan, 329-0498
    • Tokyo
      • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Collaborators

Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

January 20, 2012

First Submitted That Met QC Criteria

January 20, 2012

First Posted (Estimate)

January 25, 2012

Study Record Updates

Last Update Posted (Estimate)

January 23, 2017

Last Update Submitted That Met QC Criteria

January 19, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15960

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pulmonary Embolism

Clinical Trials on Rivaroxaban (Xarelto, BAY59-7939)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Benin

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe