Anticoagulation in Patients With Venous Thromboembolism and Cancer (VICTORIE)

VICTORIE (VTE IN CANCER - TREATMENT, OUTCOMES AND RESOURCE USE IN EUROPE)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Neoplasms; Embolism
• Intervention / Treatment: Drug: Dabigatran; Drug: Edoxaban; Drug: Apixaban; Drug: Rivaroxaban; Drug: VKA; Drug: LMWH

• Study Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with a diagnosis of (VTE) venous thromboembolism and active cancer, or a history of cancer, being treated with anticoagulation.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
VTE and history of cancer	Drug: Dabigatran; Dabigatran; Drug: Edoxaban; Edoxaban; Drug: Apixaban; Anticoagulant; Drug: Rivaroxaban; Anticoagulant; Drug: VKA; Vitamin K antagonist; Drug: LMWH; Low Molecular Weight Heparin
VTE and active cancer	Drug: Dabigatran; Dabigatran; Drug: Edoxaban; Edoxaban; Drug: Apixaban; Anticoagulant; Drug: Rivaroxaban; Anticoagulant; Drug: VKA; Vitamin K antagonist; Drug: LMWH; Low Molecular Weight Heparin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2020
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: November 1, 2020
• First Submitted That Met QC Criteria: November 1, 2020
• First Posted (Actual): November 6, 2020

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Neoplasms; Venous thromboembolism; Eliquis; Anti-Coagulation
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Thromboembolism; Neoplasms; Embolism; Venous Thromboembolism; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carbohydrates; Heparin; Glycosaminoglycans; Polysaccharides; Morpholines; Oxazines; Thiophenes; Rivaroxaban; Dabigatran; Heparin, Low-Molecular-Weight; apixaban; edoxaban
• Other Study ID Numbers: B0661150; VICTORIE (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No