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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
10 mg twice daily for 21 days, followed by 15 mg once daily
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)
Unnamed facility
Toyoake, Aichi-ken, Japan
Unnamed facility
Aomori, Aomori, 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.
To be adjusted on the basis of prothrombin time-international normalized ratio (PT-INR) values target range (1.5 to 2.5)
Unnamed facility
Sakura, Chiba, Japan
Unnamed facility
Fukuoka, Fukuoka, Japan
Unnamed facility
Maebashi, Gunma, Japan
Unnamed facility
Ōtake, Hiroshima, Japan
Unnamed facility
Sapporo, Hokkaido, Japan
Unnamed facility
Takarazuka, Hyōgo, Japan
Unnamed facility
Kahoku-gun, Ishikawa-ken, Japan
Unnamed facility
Kanazawa, Ishikawa-ken, Japan
...and 19 more locations