Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE)
Conditions
Keywords
Thromboembolism, Embolism and Thrombosis, Vascular Diseases, Cardiovascular Diseases, Thrombosis
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.
Interventions
DRUGRivaroxaban (Xarelto, BAY59-7939)
Cohort participants are classified as rivaroxaban patient, if the patient receives initial rivaroxaban VTE treatment. Dosing according to daily clinical routine
DRUGRecommended VTE pharmacological treatments according to international guidelines
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.
Sponsors
Janssen Research & Development, LLC
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of major bleedings defined as overt bleeding | Up to 2 years | 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 |
| Number of patients with symptomatic recurrent venous thromboembolic events | Up to 2 years | — |
| All cause mortality | Up to 2 years | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse cardiovascular events | Up to 2 years | Number of cardiovascular events will be used for descriptive statistics to summarize safety variables. |
| Number of patients with other symptomatic thromboembolic events | Up to 2 years | — |
| Treatment satisfaction (patient reported outcomes) | Up to 2 years | — |
Countries
Algeria, Egypt, Indonesia, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Malaysia, Mexico, Morocco, Philippines, Qatar, Russia, Saudi Arabia, Singapore, South Korea, Taiwan, Turkey (Türkiye), Ukraine, United Arab Emirates
Outcome results
None listed