Venous Thromboembolism (VTE)PRACTISENCT03965741
Study to Gather Information How Often Venous Thromboembolism Occurs in Prostate Cancer Patients in Sweden and How This Condition is Treated With Blood Thinners
An observational study of Venous Thromboembolism (VTE), run by Bayer at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Venous Thromboembolism (VTE)
- What is being tested?
- Rivaroxaban (Xarelto, BAY59-7939), Apixaban(Eliquis) and Pradaxa (Dabigatran etexilate)
- How many people
- 97,765 participants
- Where
- 1 siteSweden
- Study dates
- 30 May 2019to 30 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prostate Cancer VTE in Sweden: Epidemiology and Anticoagulation Treatment of VTE
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.
- Conditions
- Venous Thromboembolism (VTE)
- Being tested
- Rivaroxaban (Xarelto, BAY59-7939), Apixaban(Eliquis), Pradaxa (Dabigatran etexilate)
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban (Xarelto, BAY59-7939)Drug
Follow clinical administration
Apixaban(Eliquis)Drug
Follow clinical administration
Pradaxa (Dabigatran etexilate)Drug
Follow clinical administration
| Study group | Role | What they receive |
|---|---|---|
| Men with Prostate Cancer (PCa) | Not described Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939); Drug: Apixaban(Eliquis); Drug: Pradaxa (Dabigatran etexilate) | |
| Men without PCa | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject's socio-demographic at the date of an incident PCa diagnosis
Among men with PCa
Measured: Retrospective analysis between 2007 and 2016
Subject's clinical characteristics at the date of an incident PCa diagnosis
Among men with PCa
Measured: Retrospective analysis between 2007 and 2016
Incidence rate of cancer-related VTE
Among men with PCa
Measured: Retrospective analysis between 2007 and 2016
Cancer therapies in PCa at the initial time after diagnosis
Among men with PCa
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: Retrospective analysis between 2007 and 2016
Secondary outcomes (3)
Subject's socio-demographic at the time of inclusion into the database
Among PCa-free men from the general population
Measured: 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
Measured: Retrospective analysis between 2007 and 2016
Incidence rate of VTE events
Among PCa-free men from the general population
Measured: Retrospective analysis between 2007 and 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start30 May 2019
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Thromboembolism (VTE)Studies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 97,765 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03965741
- Sponsor's protocol ID
- 20653
- Acronym
- PRACTISE
- Status last verified
- Nov 2021
- First submitted
- 27 May 2019
- Last updated
- 30 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Cancer VTE in Sweden: Epidemiology and Anticoagulation Treatment of VTE
- ClinicalTrials.gov ID
- NCT03965741
- Acronym / sponsor ID
- PRACTISE / 20653
- Conditions
- Venous Thromboembolism (VTE)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97,765 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Study start
- 30 May 2019 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 29 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Men with Prostate Cancer (PCa) | – | Drug: Rivaroxaban (Xarelto, BAY59-7939), Drug: Apixaban(Eliquis), Drug: Pradaxa (Dabigatran etexilate) |
| Men without PCa | – | – |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939)Follow clinical administration | Drug | Men with Prostate Cancer (PCa) |
| Apixaban(Eliquis)Follow clinical administration | Drug | Men with Prostate Cancer (PCa) |
| Pradaxa (Dabigatran etexilate)Follow clinical administration | Drug | Men with Prostate Cancer (PCa) |
Primary outcome
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
3 secondary outcomes
Subject's socio-demographic at the time of inclusion into the database
Time frame: Retrospective analysis between 2007 and 2016
Subject's clinical characteristics at the time of inclusion into the database
Time frame: Retrospective analysis between 2007 and 2016
Incidence rate of VTE events
Time frame: Retrospective analysis between 2007 and 2016
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Individual participant dataSharing planned: Undecided. Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism (VTE), run by Bayer at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject's socio-demographic at the date of an incident PCa diagnosis (time frame: Retrospective analysis between 2007 and 2016). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2021.