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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03965741
Recruitment Status : Active, not recruiting
First Posted : May 29, 2019
Last Update Posted : September 14, 2020
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer

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)

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Study Type : Observational
Estimated Enrollment : 99999 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
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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



Primary Outcome Measures :
  1. Subject's socio-demographic at the date of an incident PCa diagnosis [ Time Frame: Retrospective analysis between 2007 and 2016 ]
    Among men with PCa

  2. Subject's clinical characteristics at the date of an incident PCa diagnosis [ Time Frame: Retrospective analysis between 2007 and 2016 ]
    Among men with PCa

  3. Incidence rate of cancer-related VTE [ Time Frame: Retrospective analysis between 2007 and 2016 ]
    Among men with PCa

  4. Cancer therapies in PCa at the initial time after diagnosis [ Time Frame: Retrospective analysis between 2007 and 2016 ]
    Among men with PCa

  5. 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

  6. 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

  7. 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)

  8. 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

  9. 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 :
  1. 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

  2. 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

  3. Incidence rate of VTE events [ Time Frame: Retrospective analysis between 2007 and 2016 ]
    Among PCa-free men from the general population



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03965741


Locations
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Sweden
Many locations
Multiple Locations, Sweden
Sponsors and Collaborators
Bayer
Janssen Research & Development, LLC
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03965741    
Other Study ID Numbers: 20653
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Rivaroxaban
Apixaban
Dabigatran
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants