Description of Patients With Acute Venous Thromboembolism in the UK's Clinical Practice Research Datalink Linked With Hospital Episode Statistics Dataset (CPRD-HES)

Venous Thromboembolism Clinical Trial

Official title:

Anticoagulation Treatment Patterns and Persistence After Acute Venous Thromboembolism in the UK in Routine Clinical Practice: A Retrospective Database Study of the Clinical Practice Research Datalink and the Hospital Episode Statistics Dataset

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02661568
• Other study ID #: CV185-368
• Status: Completed
• Phase: N/A
• First received: January 19, 2016
• Last updated: January 19, 2016
• Start date: September 2014
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Country: None
• Study type: Observational

Clinical Trial Summary

This study will utilize a retrospective cohort design. Using the Clinical Practice Research Datalink (CPRD) linked with Hospital Episode Statistics (HES) datasets, all patients with a record of VTE diagnosis between 1 April, 2008 and 31 March, 2013 will be identified and followed from the occurrence of VTE (index date) to the first of 24 months after the index date, end of the study period, leaving the database, or death.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38409
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

VTE events will be included if:

• they are identified by at least one Read code diagnosis of acute VTE in the CPRD, or one ICD-10 code of VTE in the HES database, during the study period; and

• they occurred in patients = 18 years old at time of VTE occurrence; and

• CPRD acceptability quality criteria are present

Exclusion Criteria:

VTE events will be excluded if:

• Patients have fewer than 12 months of computerized data available prior to VTE occurrence. The date of start of computerized records will be the latter of the patient's date of current registration with the practice or the practice's Up-to-Standard (UTS) date (date from which practice data is of research quality)

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anticoagulation treatment patterns for patients following acute Venous Thromboembolism (VTE) based on all VTE events that occur during the study period	Anticoagulation treatment pattern includes type of anticoagulant (AC), duration of AC treatment, switching between ACs and switching from AC to aspirin or other antiplatelet agents (APA).	up to 24 months following VTE occurrence	No
Secondary	Demographic characteristics (age, gender) of patients with acute VTE		up to 24 months following VTE occurrence	No
Secondary	Clinical characteristics (comorbidities, concomitant treatments, medical and surgical history) of patients with acute VTE		up to 24 months following VTE occurrence	No
Secondary	Rates of unplanned (emergency) hospital admission, major surgery, major bleeding, and VTE recurrence		up to 24 months following VTE occurrence	No
Secondary	Baseline demographic and clinical characteristics associated with the duration of AC treatment after VTE		up to 24 months following VTE occurrence	No
Secondary	Baseline demographic and clinical characteristics associated with novel oral anticoagulant (NOAC) treatment compared with vitamin K antagonist (VKA) treatment following VTE		up to 24 months following VTE occurrence	No

External Links

•   BMS Clinical Trial Information
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