Study to Gather Information How Often Venous Thromboembolism Occurs in Prostate Cancer Patients in Sweden and How This Condition is Treated With Blood Thinners

Venous Thromboembolism (VTE) Clinical Trial

— PRACTISE  

Official title:

Prostate Cancer VTE in Sweden: Epidemiology and Anticoagulation Treatment of VTE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03965741
• Other study ID #: 20653
• Status: Completed
• Start date: May 30, 2019
• Est. completion date: November 30, 2020

Study information

• Verified date: November 2021
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97765
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism
• Venous Thromboembolism (VTE)

Intervention

Drug:
• Rivaroxaban (Xarelto, BAY59-7939)
Follow clinical administration
• Apixaban(Eliquis)
Follow clinical administration
• Pradaxa (Dabigatran etexilate)
Follow clinical administration

Locations

Country	Name	City	State
Sweden	Many Locations	Multiple Locations

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Research & Development, LLC

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject's socio-demographic at the date of an incident PCa diagnosis	Among men with PCa	Retrospective analysis between 2007 and 2016
Primary	Subject's clinical characteristics at the date of an incident PCa diagnosis	Among men with PCa	Retrospective analysis between 2007 and 2016
Primary	Incidence rate of cancer-related VTE	Among men with PCa	Retrospective analysis between 2007 and 2016
Primary	Cancer therapies in PCa at the initial time after diagnosis	Among men with PCa	Retrospective analysis between 2007 and 2016
Primary	Choice of drug	Among men with PCa and a first cancer-related VTE event; To characterize the long-term anticoagulation treatment	Retrospective analysis between 2007 and 2016
Primary	Duration of treatment	Among men with PCa and a first cancer-related VTE event; To characterize the long-term anticoagulation treatment	Retrospective analysis between 2007 and 2016
Primary	Occurrence of recurrent VTE events	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)	Retrospective analysis between 2007 and 2016
Primary	Time between a first cancer-related and a recurrent VTE event	Among men with PCa and a first cancer-related VTE event	Retrospective analysis between 2007 and 2016
Primary	Incidence rates of post-VTE bleeding events leading to hospitalization, and mortality by anticoagulation treatment	Among men with PCa and a first cancer-related VTE event	Retrospective analysis between 2007 and 2016
Secondary	Subject's socio-demographic at the time of inclusion into the database	Among PCa-free men from the general population	Retrospective analysis between 2007 and 2016
Secondary	Subject's clinical characteristics at the time of inclusion into the database	Among PCa-free men from the general population	Retrospective analysis between 2007 and 2016
Secondary	Incidence rate of VTE events	Among PCa-free men from the general population	Retrospective analysis between 2007 and 2016

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