Anticoagulation in Patients With Venous Thromboembolism and Cancer

Study Overview
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Brief Summary
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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.

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

Conditions
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Neoplasms, Embolism

Intervention / Treatment
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* Drug: Apixaban
* Drug: Rivaroxaban
* Drug: Edoxaban
* Drug: Dabigatran
* Drug: VKA
* Drug: LMWH


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| VTE and history of cancer<br>VTE and history of cancer | Drug: Apixaban<br>* Anticoagulant<br>Drug: Rivaroxaban<br>* Anticoagulant<br>Drug: Edoxaban<br>* Edoxaban<br>Drug: Dabigatran<br>* Dabigatran<br>Drug: VKA<br>* Vitamin K antagonist<br>Drug: LMWH<br>* Low Molecular Weight Heparin<br>|
| VTE and active cancer<br>VTE and active cancer | Drug: Apixaban<br>* Anticoagulant<br>Drug: Rivaroxaban<br>* Anticoagulant<br>Drug: Edoxaban<br>* Edoxaban<br>Drug: Dabigatran<br>* Dabigatran<br>Drug: VKA<br>* Vitamin K antagonist<br>Drug: LMWH<br>* Low Molecular Weight Heparin<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Venous thromboembolism, Eliquis, Neoplasms, Anti-Coagulation