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

Completed

• Conditions: Venous Thromboembolism

• Registration Number: NCT02661568
• Lead Sponsor: Bristol-Myers Squibb

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-01
• Study First Submitted: 2016-01-19
• Study First Submitted QC: 2016-01-19
• Last Update Submitted: 2016-01-19
• Study First Posted: 2016-01-22
• Last Update Posted: 2016-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38409

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anticoagulation treatment patterns for patients following acute Venous Thromboembolism (VTE) based on all VTE events that occur during the study period	up to 24 months following VTE occurrence	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).

Secondary Outcome Measures

Name	Time	Method
Demographic characteristics (age, gender) of patients with acute VTE	up to 24 months following VTE occurrence
Clinical characteristics (comorbidities, concomitant treatments, medical and surgical history) of patients with acute VTE	up to 24 months following VTE occurrence
Rates of unplanned (emergency) hospital admission, major surgery, major bleeding, and VTE recurrence	up to 24 months following VTE occurrence
Baseline demographic and clinical characteristics associated with the duration of AC treatment after VTE	up to 24 months following VTE occurrence
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