Venous Thromboembolism (VTE) Treatment Study in Japanese Deep Vein Thrombosis (DVT) Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01516840
First received: January 20, 2012
Last updated: January 9, 2014
Last verified: January 2014

January 20, 2012
January 9, 2014
March 2012
December 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 ] [ Designated as safety issue: No ]
  • Number of clinically relevant bleedings [ Time Frame: Up to 2 days after last dose ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01516840 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Venous Thromboembolism (VTE) Treatment Study in Japanese Deep Vein Thrombosis (DVT) Patients
Randomized, Open-label (Double Blind Among Rivaroxaban Groups in the Initial 3 Weeks), Parallel-group, Active-controlled Study of Rivaroxaban in Patients With Acute Symptomatic Deep Vein Thrombosis Without Symptomatic Pulmonary Embolism

The objective of this study is to evaluate the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of two different dosages of rivaroxaban in the treatment of deep vein thrombosis (DVT) and the prevention of the occurrence and the recurrence of DVT or pulmonary embolism (PE) in Japanese patients with acute symptomatic DVT without symptomatic PE.

The general design of the trial is open label between the Rivaroxaban and the reference arm. However, there are two groups in the Rivaroxaban arm only for the initial 3 weeks. Between these two groups and in this initial period, the study is blinded.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Deep Vein Thrombosis
  • Drug: Rivaroxaban (Xarelto, BAY59-7939)
    10 mg twice daily for 21 days, followed by 15 mg once daily
  • 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)
  • Experimental: Arm 2
    Intervention: Drug: Rivaroxaban (Xarelto, BAY59-7939)
  • Active Comparator: Arm 3
    Intervention: Drug: Unfractionated heparin
  • Active Comparator: Arm 4
    Intervention: Drug: Warfarin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men and women >/= 20 years of age in patients with confirmed acute symptomatic proximal deep vein thrombosis (DVT) without symptomatic pulmonary embolism (PE)

Exclusion Criteria:

  • Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT
  • 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 DVT 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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01516840
14568
Yes
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
January 2014

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