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

Primary Purpose

Pulmonary Embolism

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

Rivaroxaban (Xarelto, BAY59-7939)

Unfractionated heparin

Warfarin

About this trial

This is an interventional treatment trial for Pulmonary Embolism focused on measuring acute symptomatic pulmonary embolism

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

Outcomes

Primary Outcome Measures

Number of participants with newly onset of symptomatic venous thromboembolism (VTE)

Number of clinically relevant bleedings

Secondary Outcome Measures

Number of participants with improvement in thrombotic burden

Number of participants with deterioration in thrombotic burden

Number of participants with the composite of newly onset of symptomatic VTE or asymptomatic deterioration of thrombus

Full Information

NCT ID

NCT01516814

First Posted

January 20, 2012

Last Updated

January 19, 2017

Sponsor

Bayer

Collaborators

Janssen Research & Development, LLC

1. Study Identification

Unique Protocol Identification Number

NCT01516814

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

February 2012 (undefined)

Primary Completion Date

October 2013 (Actual)

Study Completion Date

November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

Collaborators

Janssen Research & Development, LLC

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Embolism

Keywords

acute symptomatic pulmonary embolism

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Title

Arm 2

Arm Type

Active Comparator

Arm Title

Arm 3

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Rivaroxaban (Xarelto, BAY59-7939)

Intervention Description

15 mg twice daily for 21 days, followed by 15 mg once daily

Intervention Type

Drug

Intervention Name(s)

Unfractionated heparin

Intervention Description

To be adjusted to maintain the activated partial thromboplastin time (aPTT) prolongation (1.5 to 2.5 times the control)

Intervention Type

Drug

Intervention Name(s)

Warfarin

Intervention Description

To be adjusted on the basis of prothrombin time-international normalized ratio (PT-INR) values target range (1.5 to 2.5)

Primary Outcome Measure Information:

Title

Number of participants with newly onset of symptomatic venous thromboembolism (VTE)

Time Frame

Up to 12 months

Title

Number of clinically relevant bleedings

Time Frame

Up to 2 days after last dose

Secondary Outcome Measure Information:

Title

Number of participants with improvement in thrombotic burden

Time Frame

At week 3

Title

Number of participants with deterioration in thrombotic burden

Time Frame

Up to 12 months

Title

Number of participants with the composite of newly onset of symptomatic VTE or asymptomatic deterioration of thrombus

Time Frame

Up to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

457-8510

Country

Japan

City

Toyoake

State/Province

Aichi

ZIP/Postal Code

470-1192

Country

Japan

City

Sakura

State/Province

Chiba

ZIP/Postal Code

285-8741

Country

Japan

City

Kurume

State/Province

Fukuoka

ZIP/Postal Code

830-8543

Country

Japan

City

Maebashi

State/Province

Gunma

ZIP/Postal Code

371-8511

Country

Japan

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

006-8555

Country

Japan

City

Kahoku-gun

State/Province

Ishikawa

ZIP/Postal Code

920-0293

Country

Japan

City

Kanazawa

State/Province

Ishikawa

ZIP/Postal Code

920-8650

Country

Japan

City

Yokohama

State/Province

Kanagawa

ZIP/Postal Code

245-8575

Country

Japan

City

Tsu

State/Province

Mie

ZIP/Postal Code

514-8507

Country

Japan

City

Matsumoto

State/Province

Nagano

ZIP/Postal Code

390-8510

Country

Japan

City

Suwa

State/Province

Nagano

ZIP/Postal Code

392-8510

Country

Japan

City

Osakasayama

State/Province

Osaka

ZIP/Postal Code

589-8511

Country

Japan

City

Suita

State/Province

Osaka

ZIP/Postal Code

565-8565

Country

Japan

City

Shimotsuke

State/Province

Tochigi

ZIP/Postal Code

329-0498

Country

Japan

City

Bunkyo-ku

State/Province

Tokyo

ZIP/Postal Code

113-8519

Country

Japan

City

Bunkyo-ku

State/Province

Tokyo

ZIP/Postal Code

113-8655

Country

Japan

City

Chuoku

State/Province

Tokyo

ZIP/Postal Code

104-8560

Country

Japan

City

Itabashi-ku

State/Province

Tokyo

ZIP/Postal Code

173-8610

Country

Japan

City

Meguro-ku

State/Province

Tokyo

ZIP/Postal Code

152-8902

Country

Japan

City

Shinagawa

State/Province

Tokyo

ZIP/Postal Code

141-8625

Country

Japan

City

Shinjuku-ku

State/Province

Tokyo

ZIP/Postal Code

162-8655

Country

Japan

City

Aomori

ZIP/Postal Code

030-8553

Country

Japan

City

Chiba

ZIP/Postal Code

260-8677

Country

Japan

City

Kumamoto

ZIP/Postal Code

862-8505

Country

Japan

City

Niigata

ZIP/Postal Code

951-8520

Country

Japan

City

Osaka

ZIP/Postal Code

530-8480

Country

Japan

City

Osaka

ZIP/Postal Code

537-8511

Country

Japan

City

Osaka

ZIP/Postal Code

553-0003

Country

Japan

City

Saga

ZIP/Postal Code

840-8571

Country

Japan

City

Shizuoka

ZIP/Postal Code

424-8636

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

25851062

Citation

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.

Results Reference

derived

PubMed Identifier

25717286

Citation

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.

Results Reference

derived

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

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