check_circleStudy Completed

Venous Thromboembolism (VTE)

Bayer Identifier:

20653

ClinicalTrials.gov Identifier:

NCT03965741

EudraCT Number:

Not Available

EU CT Number:

Not Available
Study to gather information how often venous thromboembolism occurs in prostate cancer patients in Sweden and how this condition is treated with blood thinners

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

NaN - N/A
  • -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.
  • -None

Trial summary

Enrollment Goal
97765
Trial Dates
May 2019 - November 2020
Phase
Phase 4
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many LocationsMany Locations, Sweden

Primary Outcome

  • Subject's socio-demographic at the date of an incident PCa diagnosis
    Among men with PCa
    date_rangeTime Frame:
    Retrospective analysis between 2007 and 2016
  • Subject's clinical characteristics at the date of an incident PCa diagnosis
    Among men with PCa
    date_rangeTime Frame:
    Retrospective analysis between 2007 and 2016
  • Incidence rate of cancer-related VTE
    Among men with PCa
    date_rangeTime Frame:
    Retrospective analysis between 2007 and 2016
  • Cancer therapies in PCa at the initial time after diagnosis
    Among men with PCa
    date_rangeTime Frame:
    Retrospective analysis between 2007 and 2016
  • Choice of drug
    Among men with PCa and a first cancer-related VTE event； To characterize the long-term anticoagulation treatment
    date_rangeTime Frame:
    Retrospective analysis between 2007 and 2016
  • Duration of treatment
    Among men with PCa and a first cancer-related VTE event； To characterize the long-term anticoagulation treatment
    date_rangeTime Frame:
    Retrospective analysis between 2007 and 2016
  • 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)
    date_rangeTime Frame:
    Retrospective analysis between 2007 and 2016
  • Time between a first cancer-related and a recurrent VTE event
    Among men with PCa and a first cancer-related VTE event
    date_rangeTime Frame:
    Retrospective analysis between 2007 and 2016
  • 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
    date_rangeTime Frame:
    Retrospective analysis between 2007 and 2016

Secondary Outcome

  • Subject's socio-demographic at the time of inclusion into the database
    Among PCa-free men from the general population
    date_rangeTime Frame:
    Retrospective analysis between 2007 and 2016
  • Subject's clinical characteristics at the time of inclusion into the database
    Among PCa-free men from the general population
    date_rangeTime Frame:
    Retrospective analysis between 2007 and 2016
  • Incidence rate of VTE events
    Among PCa-free men from the general population
    date_rangeTime Frame:
    Retrospective analysis between 2007 and 2016

Trial design

Prostate cancer VTE in Sweden: epidemiology and anticoagulation treatment of VTE
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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