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

Deep Vein Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01516840
• Other study ID #: 14568
• Status: Completed
• Phase: Phase 3
• First received: January 20, 2012
• Last updated: January 17, 2017
• Start date: March 2012
• Est. completion date: January 2014

Study information

• Verified date: January 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Thrombosis
• Venous Thromboembolism
• Venous Thrombosis

Intervention

Drug:
• Rivaroxaban (Xarelto, BAY59-7939)
10 mg twice daily for 21 days, followed by 15 mg once daily
• Rivaroxaban (Xarelto, BAY59-7939)
15 mg twice daily for 21 days, followed by 15 mg once daily
• Unfractionated heparin
To be adjusted to maintain the activated partial thromboplastin time (aPTT) prolongation (1.5 to 2.5 times the control)
• Warfarin
To be adjusted on the basis of prothrombin time-international normalized ratio (PT-INR) values target range (1.5 to 2.5)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Scientific Affairs, LLC

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with newly onset of symptomatic venous thromboembolism (VTE)		Up to 12 months
Primary	Number of clinically relevant bleedings		Up to 2 days after last dose
Secondary	Number of participants with improvement in thrombotic burden		At week 3
Secondary	Number of participants with deterioration in thrombotic burden		Up to 12 months
Secondary	Number of participants with the composite of newly onset of symptomatic VTE or asymptomatic deterioration of thrombus		Up to 12 months

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