check_circleStudy Completed

Deep Vein Thrombosis, Venous Thrombosis

Bayer Identifier:

15915

ClinicalTrials.gov Identifier:

NCT01619007

EudraCT Number:

Not Available

EU CT Number:

Not Available
Treatment of an acute deep vein thrombosis (DVT) with either rivaroxaban or current standard of care therapy

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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

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

Trial summary

Enrollment Goal
5145
Trial Dates
June 2012 - July 2015
Phase
N/A
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Germany
Completed
Many Locations, Switzerland
Completed
Many Locations, United Kingdom
Completed
Many Locations, France
Withdrawn
Many Locations, Poland
Completed
Many Locations, Italy
Completed
Many Locations, Spain
Completed
Many Locations, Belgium
Completed
Many Locations, Netherlands
Completed
Many Locations, Sweden
Completed
Many Locations, Denmark
Completed
Many Locations, Norway
Completed
Many Locations, Czech Republic
Completed
Many Locations, Israel
Completed
Many Locations, Portugal
Completed
Many Locations, Austria
Completed
Many Locations, Hungary
Completed
Many Locations, Greece
Withdrawn
Many Locations, Slovakia
Completed
Many Locations, Ukraine
Completed
Many Locations, Slovenia
Withdrawn
Many Locations, Ireland
Completed
Many Locations, Moldova
Completed
Many Locations, Canada

Primary Outcome

  • 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
    date_rangeTime Frame:
    after approximately 2 years or 30 days after stop of therapy
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of patients with symptomatic recurrent venous thromboembolic events
    date_rangeTime Frame:
    after approximately 2 years or 30 days after stop of therapy
    enhanced_encryption
    Safety Issue:
    Yes
  • All cause mortality
    date_rangeTime Frame:
    after approximately 2 years or 30 days after stop of therapy
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Safety variables will be summarized using descriptive statistics based on adverse cardiac events collection
    date_rangeTime Frame:
    after approximately 2 years or 30 days after stop of therapy
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of patients with other symptomatic thromboembolic events
    date_rangeTime Frame:
    after approximately 2 years or 30 days after stop of therapy
    enhanced_encryption
    Safety Issue:
    Yes
  • Treatment satisfaction (patient reported outcomes)
    date_rangeTime Frame:
    after approximately 2 years or 30 days after stop of therapy
    enhanced_encryption
    Safety Issue:
    No

Trial design

Xarelto® for Long-term and Initial Anticoagulation in Venous Thromboembolism (VTE)
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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