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

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT02661516
• Lead Sponsor: Bristol-Myers Squibb

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• 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: 16513

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.

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Impact of bleeding events on the risk of subsequent clinical events including subsequent bleeds assessed based on hazard ratios	Up to 24 months after initial treatment with VKA
Impact of bleeding events on the rate of health-care resource utilization (HCRU) assessed based on incidence rate ratios	Up to 24 months after initial treatment with VKA
Impact of bleeding events on the health-care costs in NVAF patients treated by VKAs assessed based on ratios of costs associated with number of bleeding events	Up to 24 months after initial treatment with VKA

Secondary Outcome Measures

Name	Time	Method
Characteristics of NVAF patients newly treated with VKA who experience bleeding events	Up to 24 months after initial treatment with VKA
Characteristics of NVAF patients newly treated with VKA who do not experience bleeding events	Up to 24 months after initial treatment with VKA
Variation of impact of bleeding events on clinical events, the rate of HCRU, and health-care costs over time following each bleeding event in NVAF patients treated by VKA	Upto 24 months after initial treatment with VKA