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

NCT02210819 | Completed

• 2 other identifiers: 17237XA1402
• Study Type: observational
• Target: 1,987
• Locations: 21 countries
• Sites: 21

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 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.

Conditions

Deep Vein Thrombosis (DVT); Pulmonary Embolism (PE)

Keywords

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis

Outcome Measures

Primary Outcomes (3)

• 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

  Up to 2 years

• Number of patients with symptomatic recurrent venous thromboembolic events

  Up to 2 years

• All cause mortality

  Up to 2 years

Secondary Outcomes (3)

• Number of adverse cardiovascular events

  Up to 2 years

• Number of patients with other symptomatic thromboembolic events

  Up to 2 years

• Treatment satisfaction (patient reported outcomes)

  Up to 2 years

Study Arms (2)

Rivaroxaban

Patients who will be treated for an acute venous thromboembolism (VTE) with rivaroxaban.

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Standard of care

Patients who will be treated for an acute venous thromboembolism (VTE) with current standard of care.

Drug: Recommended VTE pharmacological treatments according to international guidelines

Interventions

Rivaroxaban (Xarelto, BAY59-7939) DRUG

Cohort participants are classified as "rivaroxaban" patient, if the patient receives initial rivaroxaban VTE treatment. Dosing according to daily clinical routine

Rivaroxaban

Recommended VTE pharmacological treatments according to international guidelines DRUG

Cohort participants are classified as "Standard of care" patients, if the patient receives recommended VTE pharmacological treatments according to international guidelines, e.g. unfractionated heparin, LMWH, fondaparinux, VKA, if these are also approved pharmacological treatments for VTE in the respective country. Dosing according to daily clinical routine.

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

In- and outpatients in sites participating in the study.

You may qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead
• Janssen Research & Development, LLC: collaborator

Study Sites (21)

Unknown Facility

Multiple Locations, Algeria

Location

Unknown Facility

Multiple Locations, Egypt

Location

Unknown Facility

Multiple Locations, Indonesia

Location

Unknown Facility

Multiple Locations, Jordan

Location

Unknown Facility

Multiple Locations, Kazakhstan

Location

Unknown Facility

Multiple Locations, Kenya

Location

Unknown Facility

Multiple Locations, Kuwait

Location

Unknown Facility

Multiple Locations, Lebanon

Location

Unknown Facility

Multiple Locations, Malaysia

Location

Unknown Facility

Multiple Locations, Mexico

Location

Unknown Facility

Multiple Locations, Morocco

Location

Unknown Facility

Multiple Locations, Philippines

Location

Unknown Facility

Multiple Locations, Qatar

Location

Unknown Facility

Multiple Locations, Russia

Location

Unknown Facility

Multiple Locations, Saudi Arabia

Location

Unknown Facility

Multiple Locations, Singapore

Location

Unknown Facility

Multiple Locations, South Korea

Location

Unknown Facility

Multiple Locations, Taiwan

Location

Unknown Facility

Multiple Locations, Turkey (Türkiye)

Location

Unknown Facility

Multiple Locations, Ukraine

Location

Unknown Facility

Multiple Locations, United Arab Emirates

Location

MeSH Terms

Conditions

Venous Thrombosis; Pulmonary Embolism; Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2014
• First Posted: August 7, 2014
• Study Start: June 27, 2014
• Primary Completion: November 3, 2016
• Study Completion: January 20, 2017
• Last Updated: August 29, 2019

Record last verified: 2019-08

Locations

ID (1); LE (1); QA (1); KR (1); RU (1); JO (1); KA (1); KU (1); TU (1); AL (1); KE (1); MY (1); EG (1); MO (1); AE (1); ME (1); TW (1); SA (1); UA (1); PH (1); SG (1)