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
• 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
• 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

Related Conditions & MeSH terms

• Embolism
• Neoplasms
• Thromboembolism
• Venous Thromboembolism

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

External Links

•   To obtain contact information for a study center near you, click here.