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

NCT02661568 | Completed

• 1 other identifier: CV185-368
• Study Type: observational
• Target: 38,409
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Venous Thromboembolism

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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

Study Arms (1)

Population with condition and with exposure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic, community sample and residents of a community

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Related Links

• Investigator Inquiry form

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2016
• First Posted: January 22, 2016
• Study Start: September 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 22, 2016

Record last verified: 2016-01