Anticoagulation in Patients With Venous Thromboembolism and Cancer

NCT04618913 | Active Not Recruiting FDA Drug

• 2 other identifiers: B0661150VICTORIE
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neoplasms; Embolism

Keywords

Venous thromboembolism; Eliquis; Neoplasms; Anti-Coagulation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

VTE and history of cancer

VTE and history of cancer

Drug: Apixaban; Drug: Rivaroxaban; Drug: Edoxaban; Drug: Dabigatran; Drug: VKA; Drug: LMWH

VTE and active cancer

VTE and active cancer

Drug: Apixaban; Drug: Rivaroxaban; Drug: Edoxaban; Drug: Dabigatran; Drug: VKA; Drug: LMWH

Interventions

Apixaban DRUG

Anticoagulant

VTE and active cancer; VTE and history of cancer

Rivaroxaban DRUG

Anticoagulant

VTE and active cancer; VTE and history of cancer

Edoxaban DRUG

Edoxaban

VTE and active cancer; VTE and history of cancer

Dabigatran DRUG

Dabigatran

VTE and active cancer; VTE and history of cancer

VKA DRUG

Vitamin K antagonist

VTE and active cancer; VTE and history of cancer

LMWH DRUG

Low Molecular Weight Heparin

VTE and active cancer; VTE and history of cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

London, United Kingdom

Location

Related Links

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

MeSH Terms

Conditions

Neoplasms; Embolism; Venous Thromboembolism

Interventions

apixaban; Rivaroxaban; edoxaban; Dabigatran; Heparin, Low-Molecular-Weight

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thromboembolism

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridines; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2020
• First Posted: November 6, 2020
• Study Start: December 14, 2020
• Primary Completion: April 6, 2026
• Study Completion: April 6, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)