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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)

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ClinicalTrials.gov Identifier: NCT03965741
Recruitment Status : Active, not recruiting
First Posted : May 29, 2019
Last Update Posted : October 12, 2020
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date May 27, 2019
First Posted Date May 29, 2019
Last Update Posted Date October 12, 2020
Actual Study Start Date May 30, 2019
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 27, 2019)
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 27, 2019)
  • 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
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
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
  • Drug: Rivaroxaban (Xarelto, BAY59-7939)
    Follow clinical administration
  • Drug: Apixaban(Eliquis)
    Follow clinical administration
  • Drug: Pradaxa (Dabigatran etexilate)
    Follow clinical administration
Study Groups/Cohorts
  • Men with Prostate Cancer (PCa)
    Interventions:
    • Drug: Rivaroxaban (Xarelto, BAY59-7939)
    • Drug: Apixaban(Eliquis)
    • Drug: Pradaxa (Dabigatran etexilate)
  • Men without PCa
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: May 27, 2019)
99999
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 30, 2020
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Male
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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.

Responsible Party Bayer
Study Sponsor Bayer
Collaborators Janssen Research & Development, LLC
Investigators Not Provided
PRS Account Bayer
Verification Date October 2020