Clinical trial NCT02661516: Clinical and Economic Burden of Bleeding Events in Patients in the UK With Non-valvular Atrial Fibrillation Treated With Vitamin k Antagonists
Official title: Clinical and Economic Burden of Bleeding Events in Patients in the UK With Non-Valvular Atrial Fibrillation Treated With Vitamin K Antagonists
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-01-22
Enrollment: 16513
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retrospective cohort with study period from January 1, 2003 to December 31, 2013 using the Clinical Practice Research Datalink (CPRD). The study will identify AF patients treated with VKA during the study period and will follow them from the first record of VKA use (index date). until the first of end of study period, leaving the database, VKA discontinuation/switch, or death. It will use person-time denominators to handle the varying length of follow-up of patients

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).


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)

Primary outcomes:
measure: Impact of bleeding events on the risk of subsequent clinical events including subsequent bleeds assessed based on hazard ratios
timeFrame: Up to 24 months after initial treatment with VKA
measure: Impact of bleeding events on the rate of health-care resource utilization (HCRU) assessed based on incidence rate ratios
timeFrame: Up to 24 months after initial treatment with VKA
measure: 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
timeFrame: Up to 24 months after initial treatment with VKA
Secondary outcomes:
measure: 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
timeFrame: Upto 24 months after initial treatment with VKA
measure: Characteristics of NVAF patients newly treated with VKA who experience bleeding events
timeFrame: Up to 24 months after initial treatment with VKA
measure: Characteristics of NVAF patients newly treated with VKA who do not experience bleeding events
timeFrame: Up to 24 months after initial treatment with VKA
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: