Clinical and Economic Burden of Bleeding Events in Patients in the UK With Non-valvular Atrial Fibrillation Treated With Vitamin k Antagonists

NCT ID: NCT02661516

Last Updated: 2016-01-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 16513 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-12-31

Brief Summary

The purpose of the study is to estimate the impact of bleeding events in patients in the UK with non-valvular atrial fibrillation (NVAF) treated with vitamin K antagonists (VKA).

Conditions

Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Vitamin K Antagonists

Vitamin K Antagonists dose as specified

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

For the CPRD-HES cohort, patients will be included if they meet these criteria:

• Have CPRD data linked to HES
• Have an AF diagnosis (based on Read codes from CPRD or ICD-10 codes from HES) and have been treated with VKA during the study period

-≥18 years old at index date

• CPRD acceptability quality criteria are present.

For the CPRD cohort, patients will be included if they meet the following criteria:

• Have an Atrial Fibrillation (AF) diagnosis (based on Read codes from CPRD) and have been treated with VKAs during the study period
• ≥18 years old at index date
• CPRD acceptability quality criteria are present.

Exclusion Criteria

For the two cohorts of interest, patients will be excluded if they meet the following criteria:

• Fewer than 12 months of computerised data available prior to the index date (in order to provide a minimum amount of computerised history and to avoid issues associated with updating records when a patient joins a practice). The date of start of computerized records will be the latter of the patient's date of registration with the practice or the practice's Up-to-Standard (UTS) date (when the practice is deemed to be contributing data of adequate quality)
• The practice is not UTS, or the patient is deemed "unacceptable" according to CPRD's quality criteria
• There is evidence of valvular disease, repair, or replacement before (ie, up to 12 months prior to the index date) or during the study period
• There are records of Novel anticoagulant (NOAC)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Related Links

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

CV185-338

Identifier Type: -

Identifier Source: org_study_id