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: November 27, 2014

Last verified: November 2014

History of Changes

Tracking Information

First Received Date ^ICMJE

January 20, 2012

Last Updated Date

November 27, 2014

Start Date ^ICMJE

February 2012

Primary Completion Date

October 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01516814 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Pulmonary Embolism

Intervention ^ICMJE

Drug: Rivaroxaban (Xarelto, BAY59-7939)
15 mg twice daily for 21 days, followed by 15 mg once daily
Drug: Unfractionated heparin
To be adjusted to maintain the activated partial thromboplastin time (aPTT) prolongation (1.5 to 2.5 times the control)
Drug: Warfarin
To be adjusted on the basis of prothrombin time-international normalized ratio (PT-INR) values target range (1.5 to 2.5)

Study Arm (s)

Experimental: Arm 1
Intervention: Drug: Rivaroxaban (Xarelto, BAY59-7939)
Active Comparator: Arm 2
Intervention: Drug: Unfractionated heparin
Active Comparator: Arm 3
Intervention: Drug: Warfarin

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2013

Primary Completion Date

October 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Japan

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01516814

Other Study ID Numbers ^ICMJE

15960

Has Data Monitoring Committee

Yes

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Bayer

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

November 2014

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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