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出境医 / 临床实验 / 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)
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)
Study Description
Brief 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.
| Condition or disease | Intervention/treatment |
|---|---|
| Venous Thromboembolism (VTE) | Drug: Rivaroxaban (Xarelto, BAY59-7939) Drug: Apixaban(Eliquis) Drug: Pradaxa (Dabigatran etexilate) |
Study Design
| Study Type : | Observational |
| Actual Enrollment : | 97765 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | Prostate Cancer VTE in Sweden: Epidemiology and Anticoagulation Treatment of VTE |
| Actual Study Start Date : | May 30, 2019 |
| Actual Primary Completion Date : | November 30, 2020 |
| Actual Study Completion Date : | November 30, 2020 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
| Men with Prostate Cancer (PCa) |
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Follow clinical administration
Drug: Apixaban(Eliquis) Follow clinical administration
Drug: Pradaxa (Dabigatran etexilate) Follow clinical administration
|
| Men without PCa |
Outcome Measures
Primary Outcome Measures :
- Subject's socio-demographic at the date of an incident PCa diagnosis [ Time Frame: Retrospective analysis between 2007 and 2016 ]Among men with PCa
- Subject's clinical characteristics at the date of an incident PCa diagnosis [ Time Frame: Retrospective analysis between 2007 and 2016 ]Among men with PCa
- Incidence rate of cancer-related VTE [ Time Frame: Retrospective analysis between 2007 and 2016 ]Among men with PCa
- Cancer therapies in PCa at the initial time after diagnosis [ Time Frame: Retrospective analysis between 2007 and 2016 ]Among men with PCa
- 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
- 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
- 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)
- 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
- 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 Outcome Measures :
- 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
- 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
- Incidence rate of VTE events [ Time Frame: Retrospective analysis between 2007 and 2016 ]Among PCa-free men from the general population
Eligibility Criteria
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Based on the data from the Prostate Cancer Database Sweden (PCBaSe), containing information from many national registries other than the Cancer register, such as Patient register, Dispensed drug register, Cause of Death registry and Population registries.
Criteria
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
Contacts and Locations
Locations
| Sweden | |
| Many locations | |
| Multiple Locations, Sweden | |
Sponsors and Collaborators
Bayer
Janssen Research & Development, LLC
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 27, 2019 | ||||
| First Posted Date | May 29, 2019 | ||||
| Last Update Posted Date | December 9, 2020 | ||||
| Actual Study Start Date | May 30, 2019 | ||||
| Actual Primary Completion Date | November 30, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Study to Gather Information How Often Venous Thromboembolism Occurs in Prostate Cancer Patients in Sweden and How This Condition is Treated With Blood Thinners | ||||
| Official Title | Prostate Cancer VTE in Sweden: Epidemiology and Anticoagulation Treatment of VTE | ||||
| Brief 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. | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Based on the data from the Prostate Cancer Database Sweden (PCBaSe), containing information from many national registries other than the Cancer register, such as Patient register, Dispensed drug register, Cause of Death registry and Population registries. | ||||
| Condition | Venous Thromboembolism (VTE) | ||||
| Intervention |
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| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
97765 | ||||
| Original Estimated Enrollment |
99999 | ||||
| Actual Study Completion Date | November 30, 2020 | ||||
| Actual Primary Completion Date | November 30, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | Child, Adult, Older Adult | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Sweden | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03965741 | ||||
| Other Study ID Numbers | 20653 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Bayer | ||||
| Study Sponsor | Bayer | ||||
| Collaborators | Janssen Research & Development, LLC | ||||
| Investigators | Not Provided | ||||
| PRS Account | Bayer | ||||
| Verification Date | December 2020 | ||||
