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Completed

NCT Number: NCT03965741

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

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.

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Key information

Conditions

Venous Thromboembolism (VTE) Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Vascular Diseases Venous Thromboembolism

Sex eligibility

Male

Study type

Observational

Primary location

Many Locations

Multiple Locations, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivaroxaban (Xarelto, BAY59-7939)

Drug

Follow clinical administration

Apixaban(Eliquis)

Drug

Follow clinical administration

Pradaxa (dabigatran etexilate)

Drug

Follow clinical administration

Primary outcomes

  1. Subject's socio-demographic at the date of an incident PCa diagnosis

    Time frame: Retrospective analysis between 2007 and 2016

    Among men with PCa

  2. Subject's clinical characteristics at the date of an incident PCa diagnosis

    Time frame: Retrospective analysis between 2007 and 2016

    Among men with PCa

  3. Incidence rate of cancer-related VTE

    Time frame: Retrospective analysis between 2007 and 2016

    Among men with PCa

  4. Cancer therapies in PCa at the initial time after diagnosis

    Time frame: Retrospective analysis between 2007 and 2016

    Among men with PCa

  5. Choice of drug

    Time frame: Retrospective analysis between 2007 and 2016

    Among men with PCa and a first cancer-related VTE event； To characterize the long-term anticoagulation treatment

  6. Duration of treatment

    Time frame: Retrospective analysis between 2007 and 2016

    Among men with PCa and a first cancer-related VTE event； To characterize the long-term anticoagulation treatment

  7. Occurrence of recurrent VTE events

    Time frame: 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)

  8. Time between a first cancer-related and a recurrent VTE event

    Time frame: Retrospective analysis between 2007 and 2016

    Among men with PCa and a first cancer-related VTE event

  9. Incidence rates of post-VTE bleeding events leading to hospitalization, and mortality by anticoagulation treatment

    Time frame: Retrospective analysis between 2007 and 2016

    Among men with PCa and a first cancer-related VTE event

Secondary outcomes

  1. Subject's socio-demographic at the time of inclusion into the database

    Time frame: Retrospective analysis between 2007 and 2016

    Among PCa-free men from the general population

  2. Subject's clinical characteristics at the time of inclusion into the database

    Time frame: Retrospective analysis between 2007 and 2016

    Among PCa-free men from the general population

  3. Incidence rate of VTE events

    Time frame: Retrospective analysis between 2007 and 2016

    Among PCa-free men from the general population

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Research & Development, LLC

Registry information

Official study title

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

Acronym: PRACTISE

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 29, 2019
Registry last updated
Nov 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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