Anticoagulation in Patients With Venous Thromboembolism and Cancer

Active, not recruiting

• Conditions: Neoplasms; Embolism
• Interventions: Drug: Apixaban; Drug: Rivaroxaban; Drug: Edoxaban; Drug: Dabigatran; Drug: VKA; Drug: LMWH

• Registration Number: NCT04618913
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-01
• Study First Submitted QC: 2020-11-01
• Study First Posted: 2020-11-06
• Study Start: 2020-12-14
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-06
• Primary Completion: 2025-06-02
• Study Completion: 2025-06-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
VTE and history of cancer	Rivaroxaban	VTE and history of cancer
VTE and active cancer	Edoxaban	VTE and active cancer
VTE and history of cancer	Dabigatran	VTE and history of cancer
VTE and active cancer	LMWH	VTE and active cancer
VTE and history of cancer	Edoxaban	VTE and history of cancer
VTE and history of cancer	LMWH	VTE and history of cancer
VTE and history of cancer	VKA	VTE and history of cancer
VTE and active cancer	VKA	VTE and active cancer
VTE and history of cancer	Apixaban	VTE and history of cancer
VTE and active cancer	Apixaban	VTE and active cancer
VTE and active cancer	Rivaroxaban	VTE and active cancer
VTE and active cancer	Dabigatran	VTE and active cancer

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 London, United Kingdom