Pulmonary Embolism
Conditions
Keywords
acute symptomatic pulmonary embolism
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.
Interventions
DRUGRivaroxaban (Xarelto, BAY59-7939)
15 mg twice daily for 21 days, followed by 15 mg once daily
DRUGUnfractionated heparin
To be adjusted to maintain the activated partial thromboplastin time (aPTT) prolongation (1.5 to 2.5 times the control)
DRUGWarfarin
To be adjusted on the basis of prothrombin time-international normalized ratio (PT-INR) values target range (1.5 to 2.5)
Sponsors
Janssen Research & Development, LLC
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with newly onset of symptomatic venous thromboembolism (VTE) | Up to 12 months |
| Number of clinically relevant bleedings | Up to 2 days after last dose |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with improvement in thrombotic burden | At week 3 |
| Number of participants with deterioration in thrombotic burden | Up to 12 months |
| Number of participants with the composite of newly onset of symptomatic VTE or asymptomatic deterioration of thrombus | Up to 12 months |
Countries
Japan
Outcome results
None listed