Treatment of an Acute Deep Vein Thrombosis (DVT) With Either Rivaroxaban or Current Standard of Care Therapy

Completed

• Conditions: Venous Thrombosis; Deep Vein Thrombosis
• Interventions: Drug: Rivaroxaban (Xarelto, BAY59-7939); Drug: Standard of care

• Registration Number: NCT01619007
• Lead Sponsor: Bayer

Brief Summary

Following the findings of the clinical trials in drug development, this global non-interventional cohort field study will investigate rivaroxaban under clinical practice conditions in comparison with current standard of care for patients with acute deep vein thrombosis (DVT).

The main goal is to analyze long-term safety in the use of rivaroxaban in the treatment of acute DVT in routine clinical practice.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-29
• Study Start: 2012-06
• Study First Submitted QC: 2012-06-12
• Study First Posted: 2012-06-14
• Primary Completion: 2015-03
• Study Completion: 2015-07
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-20
• Last Update Posted: 2017-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5145

Inclusion Criteria

• Female and male patients
• Patients >= 18 years
• Patiebts with diagnosis of acute DVT and who have an indication for anticoagulation therapy for at least 12 weeks, who are willing to participate in this study and are available for follow-up

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Exclusion Criteria

• Exclusion criteria must be read in conjunction with the local product information.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Rivaroxaban (Xarelto, BAY59-7939)	-
Group 2	Standard of care	-

Primary Outcome Measures

Name	Time	Method
All cause mortality	after approximately 2 years or 30 days after stop of therapy
Number of patients with symptomatic recurrent venous thromboembolic events	after approximately 2 years or 30 days after stop of therapy
Major bleedings defined as overt bleeding associated with: A fall in hemoglobin of ≥2 g/dL; or a transfusion of ≥2 units of packed red blood cells or whole blood; or occurrence at a critical site	after approximately 2 years or 30 days after stop of therapy

Secondary Outcome Measures

Name	Time	Method
Treatment satisfaction (patient reported outcomes)	after approximately 2 years or 30 days after stop of therapy
Safety variables will be summarized using descriptive statistics based on adverse cardiac events collection	after approximately 2 years or 30 days after stop of therapy
Number of patients with other symptomatic thromboembolic events	after approximately 2 years or 30 days after stop of therapy