VICTORIE: Anticoagulation in Patients With Venous Thromboembolism and Cancer

Sponsor

Pfizer (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04618913

Collaborator

(none)

Enrollment

Location

24.5

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasms Embolism	Drug: Apixaban Drug: Rivaroxaban Drug: Edoxaban Drug: Dabigatran Drug: VKA Drug: LMWH

Study Design

Study Type:

Observational

Actual Enrollment :

1 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Dec 14, 2020

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

VTE and history of cancer

Drug: Apixaban

Anticoagulant

Drug: Rivaroxaban

Anticoagulant

Drug: Edoxaban

Edoxaban

Drug: Dabigatran

Dabigatran

Drug: VKA

Vitamin K antagonist

Drug: LMWH

Low Molecular Weight Heparin

VTE and active cancer

Drug: Apixaban

Anticoagulant

Drug: Rivaroxaban

Anticoagulant

Drug: Edoxaban

Edoxaban

Drug: Dabigatran

Dabigatran

Drug: VKA

Vitamin K antagonist

Drug: LMWH

Low Molecular Weight Heparin

Outcome Measures

Primary Outcome Measures

Recurrence of Thromboembolism [6 Months after treatment began as early as 1/1/2013]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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