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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01516840

Enrollment

Registered

2012-01-25

Start date

2012-03-31

Completion date

2014-01-31

Last updated

2017-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Vein Thrombosis

Keywords

acute symptomatic deep vein thrombosis

Brief summary

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.

Detailed description

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.

Interventions

DRUGRivaroxaban (Xarelto, BAY59-7939)

10 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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

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 the composite of newly onset of symptomatic VTE or asymptomatic deterioration of thrombus	Up to 12 months
Number of participants with improvement in thrombotic burden	At week 3
Number of participants with deterioration in thrombotic burden	Up to 12 months

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026