check_circleStudy Completed

Deep vein thrombosis (DVT), Pulmonary embolism (PE)

Bayer Identifier:

17237

ClinicalTrials.gov Identifier:

NCT02210819

EudraCT Number:

Not Available

EU CT Number:

Not Available
Treatment of venous thromboembolism (VTE) 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 venous thoromboembolism (VTE).
The main goal is to analyze long-term safety in the use of rivaroxaban in the treatment of acute VTE in routine clinical practice.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - Female or male patients, who are at >=18 years
    - Diagnosis of acute DVT and/or PE, objectively confirmed
    - Indication for anticoagulation therapy for at least 12 weeks
    - Willing to participate in this study and available for follow-up

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

Trial summary

Enrollment Goal
1987
Trial Dates
June 2014 - January 2017
Phase
Phase 4
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Mexico
Terminated
Many Locations, Turkey
Completed
Many Locations, Russia
Completed
Many Locations, Korea, Republic Of
Completed
Many Locations, Taiwan
Completed
Many Locations, Malaysia
Completed
Many Locations, Philippines
Completed
Many Locations, Singapore
Completed
Many Locations, Egypt
Completed
Many Locations, Saudi Arabia
Terminated
Many Locations, Kuwait
Completed
Many Locations, Jordan
Completed
Many Locations, Lebanon
Terminated
Many Locations, Qatar
Terminated
Many Locations, United Arab Emirates
Completed
Many Locations, Kenya
Completed
Many locations, Indonesia
Completed
Many locations, Kazakhstan
Completed
Many locations, Ukraine
Completed
Many locations, Algeria
Terminated
Many Locations, Morocco
Completed
Many Locations, Saudi Arabia

Primary Outcome

  • Number of major bleedings defined as overt bleeding
    Major bleedings defined as overt bleeding are 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:
    Up to 2 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of patients with symptomatic recurrent venous thromboembolic events
    date_rangeTime Frame:
    Up to 2 years
    enhanced_encryption
    Safety Issue:
    Yes
  • All cause mortality
    date_rangeTime Frame:
    Up to 2 years
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Number of adverse cardiovascular events
    Number of cardiovascular events will be used for descriptive statistics to summarize safety variables.
    date_rangeTime Frame:
    Up to 2 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of patients with other symptomatic thromboembolic events
    date_rangeTime Frame:
    Up to 2 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Treatment satisfaction (patient reported outcomes)
    date_rangeTime Frame:
    Up to 2 years
    enhanced_encryption
    Safety Issue:
    No

Trial design

XALIA LEA- Xarelto for Long-term and Initial Anticoagulation in Venous Thromboembolism (VTE) in Latin America, EMEA and Asia
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

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer products.