PRACTISE: Study to Gather Information How Often Venous Thromboembolism Occurs in Prostate Cancer Patients in Sweden and How This Condition is Treated With Blood Thinners
Study Details
Study Description
Brief Summary
Patients with cancer are at a significantly increased risk of experiencing a venous thromboembolism (VTE). VTE is defined by a blood clot in the leg or lower extremity (deep vein thrombosis) or a blood clot in the lung (pulmonary embolism) and is a leading cause of condition of being diseased and death among cancer patients. The goal of the study is to gather information how often venous thromboembolism (VTE) occurs in prostate cancer patients in Sweden and how this condition is treated with blood thinners.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Men with Prostate Cancer (PCa)
|
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Follow clinical administration
Drug: Apixaban(Eliquis)
Follow clinical administration
Drug: Pradaxa (Dabigatran etexilate)
Follow clinical administration
|
| Men without PCa
|
Outcome Measures
Primary Outcome Measures
- Subject's socio-demographic at the date of an incident PCa diagnosis [Retrospective analysis between 2007 and 2016]
Among men with PCa
- Subject's clinical characteristics at the date of an incident PCa diagnosis [Retrospective analysis between 2007 and 2016]
Among men with PCa
- Incidence rate of cancer-related VTE [Retrospective analysis between 2007 and 2016]
Among men with PCa
- Cancer therapies in PCa at the initial time after diagnosis [Retrospective analysis between 2007 and 2016]
Among men with PCa
- Choice of drug [Retrospective analysis between 2007 and 2016]
Among men with PCa and a first cancer-related VTE event； To characterize the long-term anticoagulation treatment
- Duration of treatment [Retrospective analysis between 2007 and 2016]
Among men with PCa and a first cancer-related VTE event； To characterize the long-term anticoagulation treatment
- Occurrence of recurrent VTE events [Retrospective analysis between 2007 and 2016]
Among men with PCa and a first cancer-related VTE event； By long-term anticoagulation treatment (LMWH (Low molecular weight heparin), VKA (Vitamin K anticoagulants) or NOAC (Non-vitamin K oral anticoagulation)) and its estimated duration (up 3 months, 3-6 months, more than 6 months)
- Time between a first cancer-related and a recurrent VTE event [Retrospective analysis between 2007 and 2016]
Among men with PCa and a first cancer-related VTE event
- Incidence rates of post-VTE bleeding events leading to hospitalization, and mortality by anticoagulation treatment [Retrospective analysis between 2007 and 2016]
Among men with PCa and a first cancer-related VTE event
Secondary Outcome Measures
- Subject's socio-demographic at the time of inclusion into the database [Retrospective analysis between 2007 and 2016]
Among PCa-free men from the general population
- Subject's clinical characteristics at the time of inclusion into the database [Retrospective analysis between 2007 and 2016]
Among PCa-free men from the general population
- Incidence rate of VTE events [Retrospective analysis between 2007 and 2016]
Among PCa-free men from the general population
Eligibility Criteria
Criteria
Inclusion Criteria:
- Initially all patients newly diagnosed with PCa between 2007-2016 with at least one year before the end of follow up date (31 December 2017) will be included. From this population, a sub-population of PCa patients with a first cancer-related VTE event will be selected.
Exclusion Criteria:
- None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Many Locations | Multiple Locations | Sweden |
Sponsors and Collaborators
- Bayer
- Janssen Research & Development, LLC
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 20653