Submitted by: Mark S. de Guzman 2015-06-04 00:00:00 Last Updated by: Mark S. de Guzman 2018-06-06 14:28:32 Export to PDF

Treatment of Venous Thromboembolism (VTE) With Either Rivaroxaban or Current Standard of Care Therapy

PHRR150722-001013

XA1402

2014-CT0243

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

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).

Regime Classification Priority
2010 - 2016 Health Technology Development Drug Discovery and Development
Start Date Duration in Months Target Completion Date Actual Completion Date
2014-07-01 32 2017-03-01 2017-03-31

Completed

Institution Classification Region LTO #
Bayer Philippines, Inc. Private Business NCR CDRR-NCR-S-27
Institution Amount Region
Bayer Healthcare AG N/A Germany
Name E-Mail Phone Number Postal Address
Mark de Guzman mark.deguzman@bayer.com +632-5485800 29th Floor, Menarco Tower, 32nd Ave., Bonifacio Global City, Taguig
Name E-Mail Phone Number Postal Address
Mark de Guzman mark.deguzman@bayer.com +632-5485800 29th Floor, Menarco Tower, 32nd Ave., Bonifacio Global City, Taguig
Name Expertise Affiliation
Marie Simonette Ganzon, MD Vascular cardiology St. Luke's Medical Center - Quezon City
Rosella Arellano, MD Vascular cardiology Philippine Heart Center
Project Location Institutional Ethics Review Board
St. Luke's Medical Center - Quezon City St. Luke's Medical Center Institutional Ethics Review Board
Philippine Heart Center Philippine Heart Center Ethics Review Committee

Venous Thromboembolism

Number of major bleedings defined as overt bleeding

Number of patients with symptomatic recurrent venous thromboembolic events

All cause mortality

Number of adverse cardiovascular events

Number of patients with other symptomatic thromboembolic events

Treatment satisfaction

Completed

  • Algeria
  • Egypt
  • Indonesia
  • Jordan
  • Kazakhstan
  • Kenya
  • Kuwait
  • Lebanon
  • Malaysia
  • Mexico
  • Morocco
  • Philippines
  • Qatar
  • Russia
  • Saudi Arabia
  • Singapore
  • South Korea
  • Taiwan
  • Turkey
  • Ukraine
  • United Arab Emirates

Clinical Trial

Unspecified

2015-04-01

None

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

Observational

Unspecified

Unspecified

Non-randomized

Open Label

Unspecified

Not Applicable

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

Phase IV

50

18

Low recruitment rate

01 Jul 2014

Utilization Utilization Info
No records found.

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