Venous Thromboembolism (VTE) Treatment Study in Japanese Pulmonary Embolism (PE) Patients

Pulmonary Embolism Clinical Trial

Official title:

Randomized, Open-label, Parallel-group, Active-controlled Study of Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism, With or Without Symptomatic Deep Vein Thrombosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01516814
• Other study ID #: 15960
• Status: Completed
• Phase: Phase 3
• First received: January 20, 2012
• Last updated: January 19, 2017
• Start date: February 2012
• Est. completion date: November 2013

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2013
• Est. primary completion date: October 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 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

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism
• Venous Thromboembolism

Intervention

Drug:
• 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 Research & Development, 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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