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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01516814
Recruitment Status : Completed
First Posted : January 25, 2012
Last Update Posted : January 23, 2017
Janssen Research & Development, LLC
Information provided by (Responsible Party):

January 20, 2012
January 25, 2012
January 23, 2017
February 2012
October 2013   (Final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01516814 on Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
Venous Thromboembolism (VTE) Treatment Study in Japanese Pulmonary Embolism (PE) Patients
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.
Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pulmonary Embolism
  • 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)
  • Experimental: Arm 1
    Intervention: Drug: Rivaroxaban (Xarelto, BAY59-7939)
  • Active Comparator: Arm 2
    Intervention: Drug: Unfractionated heparin
  • Active Comparator: Arm 3
    Intervention: Drug: Warfarin

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
November 2013
October 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Janssen Research & Development, LLC
Study Director: Bayer Study Director Bayer
January 2017

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