Treatment of Venous Thromboembolism in Real-Life Patients

Completed

• Conditions: Venous Thromboembolism
• Interventions: Other: Non-Interventional

• Registration Number: NCT03087474
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

In a population of patients with venous thromboembolism and treated with oral anticoagulants (OAC) in routine clinical practice in Denmark this study will describe patients treated with each OAC

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-04
• Study First Submitted: 2017-03-02
• Study First Submitted QC: 2017-03-17
• Study First Posted: 2017-03-22
• Primary Completion: 2017-12-31
• Study Completion: 2018-06-28
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-09
• Last Update Posted: 2018-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89383

Inclusion Criteria

1. All patients ≥ 18 years diagnosed with incident VTE at Danish public hospitals from 2006 through 2015
2. First-time (index) VTE will be defined as an in- or out-patient diagnosis of DVT or PE among patients redeeming a prescription for anticoagulant drugs within 30 days after index date

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Exclusion Criteria

1. In the analyses on type and duration of anticoagulant use, Patients with cancer will be excluded as they typically receive low molecular heparin directly from the hospital and their use of anticoagulants can therefore not be captured by redeemed prescriptions at pharmacies.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
VKA patients	Non-Interventional	Vitamin K antagonist (VKA) patients
NOAC patients	Non-Interventional	nonvitamin K antagonist oral anticoagulants (NOAC) patients

Primary Outcome Measures

Name	Time	Method
Duration of Treatment in NOAC patients	Approximately 180 months
VTE hospitalization rate in VKA patients by sex	Approximately 180 months
VTE hospitalization rate in VKA patients by age	Approximately 180 months
VTE hospitalization rate in NOAC patients by age	Approximately 180 months
Hospitalization rate in VKA patients for VTE	Approximately 180 months	Hospitalization rate for first-time Venous thromboembolism (VTE) in Vitamin K antagonist (VKA) patients
Hospitalization rate in NOAC patients for VTE	Approximately 180 months	Hospitalization rate for first-time venous thromboembolism in nonvitamin K antagonist oral anticoagulants (NOAC) patients
VTE hospitalization rate in NOAC patients by sex	Approximately 180 months
Duration of treatment in VKA patients	Approximately 180 months