Clinical trial NCT02661568: Description of Patients With Acute Venous Thromboembolism in the UK's Clinical Practice Research Datalink Linked With Hospital Episode Statistics Dataset (CPRD-HES)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-01-22
Enrollment: 38409
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic, community sample and residents of a community

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Anticoagulation treatment patterns for patients following acute Venous Thromboembolism (VTE) based on all VTE events that occur during the study period
timeFrame: up to 24 months following VTE occurrence
Secondary outcomes:
measure: Demographic characteristics (age, gender) of patients with acute VTE
timeFrame: up to 24 months following VTE occurrence
measure: Clinical characteristics (comorbidities, concomitant treatments, medical and surgical history) of patients with acute VTE
timeFrame: up to 24 months following VTE occurrence
measure: Rates of unplanned (emergency) hospital admission, major surgery, major bleeding, and VTE recurrence
timeFrame: up to 24 months following VTE occurrence
measure: Baseline demographic and clinical characteristics associated with the duration of AC treatment after VTE
timeFrame: up to 24 months following VTE occurrence
measure: Baseline demographic and clinical characteristics associated with novel oral anticoagulant (NOAC) treatment compared with vitamin K antagonist (VKA) treatment following VTE
timeFrame: up to 24 months following VTE occurrence
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: