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

Tracking Information
First Submitted Date ICMJE	January 20, 2012
First Posted Date ICMJE	January 25, 2012
Last Update Posted Date	January 23, 2017
Study Start Date ICMJE	February 2012
Actual Primary Completion Date	October 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: January 20, 2012)	Number of participants with newly onset of symptomatic venous thromboembolism (VTE) [ Time Frame: Up to 12 months ]; Number of clinically relevant bleedings [ Time Frame: Up to 2 days after last dose ]
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; (submitted: January 20, 2012)	Number of participants with improvement in thrombotic burden [ Time Frame: At week 3 ]; Number of participants with deterioration in thrombotic burden [ Time Frame: 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 ]
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; Intervention Model: Parallel Assignment; Masking: None (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 Arms	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.; 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.
* 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
Actual Enrollment ICMJE; (submitted: January 20, 2012)	40
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	November 2013
Actual 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
Sex/Gender	Sexes Eligible for Study: All
Ages	20 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
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
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Bayer
Study Sponsor ICMJE	Bayer
Collaborators ICMJE	Janssen Research & Development, LLC
Investigators ICMJE	Study Director: Bayer Study Director Bayer
PRS Account	Bayer
Verification Date	January 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP