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NCT04618913 Clinical Trial

Anticoagulation in Patients With Venous Thromboembolism and Cancer

Neoplasms Clinical Trial

— VICTORIE  

Official title:
VICTORIE (VTE In Cancer - Treatment, Outcomes and Resource Use In Europe)

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04618913
Other study ID # B0661150
Secondary ID VICTORIE
Status Active, not recruiting
Phase
First received
Last updated
Start date December 14, 2020
Est. completion date December 2, 2024

Study information
Verified date April 2024
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is a retrospective analysis of observational cohorts using data from prospectively collected administrative/claims data to investigate treatment patterns,healthcare resource utilisation (HCRU), direct and indirect costs (where feasible), and safety and effectiveness outcomes in patients with VTE and active cancer or patients with VTE and history of cancer who initiate anticoagulant treatment with a VKA, LMWH or NOACs.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 1
Est. completion date December 2, 2024
Est. primary completion date December 2, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - A VTE diagnosis - Active cancer or history of cancer - Treatment with VKA, NOAC (apixaban, rivaroxaban, dabigatran, edoxaban) or LMWH - Age = 18 years at the date of index VTE (Venous thromboembolic) Exclusion Criteria: - Prior VTE diagnosis - Diagnosis of prior atrial fibrillation - Inferior Vena Cava (IVC) filter - Prior exposure to (OAC) oral anticoagulation or (PAC)parenteral anticoagulation - note: Prophylactic use of (OAC)/(PAC) allowed. - Pregnancy - More than one (OAC) oral anticoagulation or (PAC) parenteral anticoagulation dispensed on the index date. - Patients with less than one day of follow up

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Apixaban
Anticoagulant
• Rivaroxaban
Anticoagulant
• Edoxaban
Edoxaban
• Dabigatran
Dabigatran
• VKA
Vitamin K antagonist
• LMWH
Low Molecular Weight Heparin

Locations
Country Name City State
United Kingdom Pfizer Investigational Site London

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Recurrence of Thromboembolism The follow-up period during which outcome events of interest will be identified will run from the day after the index date until the end of the data collection or death, whichever occurs first. As data are updated at different times and frequencies in the different study countries, the date of the end of data collection will be determined after the relevant permissions have been acquired from the respective authorities. 6 Months after treatment began as early as 1/1/2013
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