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OpenTrials
Completed

NCT Number: NCT02661568

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

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.

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Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Anticoagulation treatment patterns for patients following acute Venous Thromboembolism (VTE) based on all VTE events that occur during the study period

    Time frame: 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 outcomes

  1. Demographic characteristics (age, gender) of patients with acute VTE

    Time frame: up to 24 months following VTE occurrence

  2. Clinical characteristics (comorbidities, concomitant treatments, medical and surgical history) of patients with acute VTE

    Time frame: up to 24 months following VTE occurrence

  3. Rates of unplanned (emergency) hospital admission, major surgery, major bleeding, and VTE recurrence

    Time frame: up to 24 months following VTE occurrence

  4. Baseline demographic and clinical characteristics associated with the duration of AC treatment after VTE

    Time frame: up to 24 months following VTE occurrence

  5. Baseline demographic and clinical characteristics associated with novel oral anticoagulant (NOAC) treatment compared with vitamin K antagonist (VKA) treatment following VTE

    Time frame: up to 24 months following VTE occurrence

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 22, 2016
Registry last updated
Jan 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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