|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02210819 |
|
Date of registration:
|
20/05/2014 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Treatment of Venous Thromboembolism (VTE) With Either Rivaroxaban or Current Standard of Care Therapy
XALIA LEA |
|
Scientific title:
|
XALIA LEA- Xarelto for Long-term and Initial Anticoagulation in Venous Thromboembolism (VTE) in Latin America, EMEA and Asia |
|
Date of first enrolment:
|
June 27, 2014 |
|
Target sample size:
|
1987 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02210819 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Algeria
|
Egypt
|
Indonesia
|
Jordan
|
Kazakhstan
|
Kenya
|
Korea, Republic of
|
Kuwait
|
|
Lebanon
|
Malaysia
|
Mexico
|
Morocco
|
Philippines
|
Qatar
|
Russian Federation
|
Saudi Arabia
|
|
Singapore
|
Taiwan
|
Turkey
|
Ukraine
|
United Arab Emirates
| | | |
|
Contacts
|
|
Name:
|
Bayer Study Director |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Bayer |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- 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:
- Exclusion criteria must be read in conjunction with the local product information.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Deep Vein Thrombosis (DVT)
|
|
Pulmonary Embolism (PE)
|
|
Intervention(s)
|
|
Drug: Rivaroxaban (Xarelto, BAY59-7939)
|
|
Drug: Recommended VTE pharmacological treatments according to international guidelines
|
|
Primary Outcome(s)
|
|
All cause mortality
[Time Frame: Up to 2 years]
|
|
Number of major bleedings defined as overt bleeding
[Time Frame: Up to 2 years]
|
|
Number of patients with symptomatic recurrent venous thromboembolic events
[Time Frame: Up to 2 years]
|
|
Secondary Outcome(s)
|
|
Number of adverse cardiovascular events
[Time Frame: Up to 2 years]
|
|
Number of patients with other symptomatic thromboembolic events
[Time Frame: Up to 2 years]
|
|
Treatment satisfaction (patient reported outcomes)
[Time Frame: Up to 2 years]
|
|
Secondary ID(s)
|
|
17237
|
|
XA1402
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|