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)

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.

Study Overview

• Status: Completed
• Conditions: Venous Thromboembolism (VTE)
• Intervention / Treatment: Drug: Rivaroxaban (Xarelto, BAY59-7939); Drug: Apixaban(Eliquis); Drug: Pradaxa (Dabigatran etexilate)

• Study Type: Observational
• Enrollment (Actual): 97765

Contacts and Locations

Study Locations

• Sweden
  • Multiple Locations, Sweden
    • Many Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject's socio-demographic at the date of an incident PCa diagnosis	Among men with PCa	Retrospective analysis between 2007 and 2016
Subject's clinical characteristics at the date of an incident PCa diagnosis	Among men with PCa	Retrospective analysis between 2007 and 2016
Incidence rate of cancer-related VTE	Among men with PCa	Retrospective analysis between 2007 and 2016
Cancer therapies in PCa at the initial time after diagnosis	Among men with PCa	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	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	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)	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	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	Retrospective analysis between 2007 and 2016

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject's socio-demographic at the time of inclusion into the database	Among PCa-free men from the general population	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	Retrospective analysis between 2007 and 2016
Incidence rate of VTE events	Among PCa-free men from the general population	Retrospective analysis between 2007 and 2016

Collaborators and Investigators

• Sponsor: Bayer
• Collaborators: Janssen Research & Development, LLC

Publications and helpful links

Helpful Links

• Click here to find results for studies related to Bayer products

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2019
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: May 27, 2019
• First Submitted That Met QC Criteria: May 27, 2019
• First Posted (Actual): May 29, 2019

Study Record Updates

• Last Update Posted (Actual): November 30, 2021
• Last Update Submitted That Met QC Criteria: November 24, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism; Venous Thromboembolism; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Rivaroxaban; Dabigatran; Apixaban
• Other Study ID Numbers: 20653

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No