Treatment of Venous Thromboembolism in Real-Life Patients

Treatment of Venous Thromboembolism in Real-Life Patients: A Nationwide, Population-Based Study

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

Study Overview

• Status: Completed
• Conditions: Venous Thromboembolism
• Intervention / Treatment: Other: Non-Interventional

• Study Type: Observational
• Enrollment (Actual): 89383

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The Danish National Patient Registry (DNPR), covering all Danish hospitals, will be used to identify first-time and recurrent VTE cases diagnosed from 01-Jan-2006 through 31-Dec-2015.

Description

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

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
VKA patients; Vitamin K antagonist (VKA) patients	Other: Non-Interventional; Non-Interventional
NOAC patients; nonvitamin K antagonist oral anticoagulants (NOAC) patients	Other: Non-Interventional; Non-Interventional

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 4, 2015
• Primary Completion (ACTUAL): December 31, 2017
• Study Completion (ACTUAL): June 28, 2018

Study Registration Dates

• First Submitted: March 2, 2017
• First Submitted That Met QC Criteria: March 17, 2017
• First Posted (ACTUAL): March 22, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 11, 2018
• Last Update Submitted That Met QC Criteria: July 9, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism; Venous Thromboembolism
• Other Study ID Numbers: CV185-496