Trial Condition(s):
Venous Thromboembolism (VTE)
Study to gather information how often venous thromboembolism occurs in prostate cancer patients in Sweden and how this condition is treated with blood thinners (PRACTISE)
Bayer Identifier:
20653
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Many Locations Many Locations, Sweden | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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:
2
Primary Outcome
- Subject's socio-demographic at the date of an incident PCa diagnosisAmong men with PCaTimeframe: Retrospective analysis between 2007 and 2016
- Subject's clinical characteristics at the date of an incident PCa diagnosisAmong men with PCaTimeframe: Retrospective analysis between 2007 and 2016
- Incidence rate of cancer-related VTEAmong men with PCaTimeframe: Retrospective analysis between 2007 and 2016
- Cancer therapies in PCa at the initial time after diagnosisAmong men with PCaTimeframe: Retrospective analysis between 2007 and 2016
- Choice of drugAmong men with PCa and a first cancer-related VTE event； To characterize the long-term anticoagulation treatmentTimeframe: Retrospective analysis between 2007 and 2016
- Duration of treatmentAmong men with PCa and a first cancer-related VTE event； To characterize the long-term anticoagulation treatmentTimeframe: Retrospective analysis between 2007 and 2016
- Occurrence of recurrent VTE eventsAmong 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)Timeframe: Retrospective analysis between 2007 and 2016
- Time between a first cancer-related and a recurrent VTE eventAmong men with PCa and a first cancer-related VTE eventTimeframe: Retrospective analysis between 2007 and 2016
- Incidence rates of post-VTE bleeding events leading to hospitalization, and mortality by anticoagulation treatmentAmong men with PCa and a first cancer-related VTE eventTimeframe: Retrospective analysis between 2007 and 2016
Secondary Outcome
- Subject's socio-demographic at the time of inclusion into the databaseAmong PCa-free men from the general populationTimeframe: Retrospective analysis between 2007 and 2016
- Subject's clinical characteristics at the time of inclusion into the databaseAmong PCa-free men from the general populationTimeframe: Retrospective analysis between 2007 and 2016
- Incidence rate of VTE eventsAmong PCa-free men from the general populationTimeframe: Retrospective analysis between 2007 and 2016
Additional Information
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