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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
15 mg twice daily for 21 days, followed by 15 mg once daily
To be adjusted to maintain the activated partial thromboplastin time (aPTT) prolongation (1.5 to 2.5 times the control)
To be adjusted on the basis of prothrombin time-international normalized ratio (PT-INR) values target range (1.5 to 2.5)
Unnamed facility
Nagoya, Aichi-ken, Japan
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
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Toyoake, Aichi-ken, Japan
Unnamed facility
Aomori, Aomori, Japan
Unnamed facility
Chiba, Chiba, Japan
Unnamed facility
Sakura, Chiba, Japan
Unnamed facility
Kurume, Fukuoka, Japan
Unnamed facility
Maebashi, Gunma, Japan
Unnamed facility
Sapporo, Hokkaido, Japan
Unnamed facility
Kahoku-gun, Ishikawa-ken, Japan
Unnamed facility
Kanazawa, Ishikawa-ken, Japan
...and 21 more locations