Treatment of Venous Thromboembolism in Real-Life Patients

Venous Thromboembolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03087474
• Other study ID #: CV185-496
• Status: Completed
• Start date: December 4, 2015
• Est. completion date: June 28, 2018

Study information

• Verified date: July 2018
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89383
• Est. completion date: June 28, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Other:
• Non-Interventional
Non-Interventional

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospitalization rate in VKA patients for VTE	Hospitalization rate for first-time Venous thromboembolism (VTE) in Vitamin K antagonist (VKA) patients	Approximately 180 months
Primary	VTE hospitalization rate in VKA patients by sex		Approximately 180 months
Primary	VTE hospitalization rate in VKA patients by age		Approximately 180 months
Primary	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
Primary	VTE hospitalization rate in NOAC patients by sex		Approximately 180 months
Primary	VTE hospitalization rate in NOAC patients by age		Approximately 180 months
Primary	Duration of Treatment in NOAC patients		Approximately 180 months
Primary	Duration of treatment in VKA patients		Approximately 180 months

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form