check_circleStudy Completed
Venous Thromboembolism (VTE)
Bayer Identifier:
20653
ClinicalTrials.gov Identifier:
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
MaleAge
NaN - N/ATrial summary
Enrollment Goal
97765Trial Dates
May 2019 - November 2020Phase
Phase 4Could I Receive a placebo
NoProducts
Xarelto (Rivaroxaban, BAY59-7939)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations | Many Locations, Sweden |
Primary Outcome
- Subject's socio-demographic at the date of an incident PCa diagnosisAmong men with PCadate_rangeTime Frame:Retrospective analysis between 2007 and 2016
- Subject's clinical characteristics at the date of an incident PCa diagnosisAmong men with PCadate_rangeTime Frame:Retrospective analysis between 2007 and 2016
- Incidence rate of cancer-related VTEAmong men with PCadate_rangeTime Frame:Retrospective analysis between 2007 and 2016
- Cancer therapies in PCa at the initial time after diagnosisAmong men with PCadate_rangeTime Frame: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 treatmentdate_rangeTime Frame: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 treatmentdate_rangeTime Frame: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)date_rangeTime Frame: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 eventdate_rangeTime Frame: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 eventdate_rangeTime Frame: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 populationdate_rangeTime Frame:Retrospective analysis between 2007 and 2016
- Subject's clinical characteristics at the time of inclusion into the databaseAmong PCa-free men from the general populationdate_rangeTime Frame:Retrospective analysis between 2007 and 2016
- Incidence rate of VTE eventsAmong PCa-free men from the general populationdate_rangeTime Frame:Retrospective analysis between 2007 and 2016
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A