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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02661516
• Other study ID #: CV185-338
• Status: Completed
• Phase: N/A
• First received: January 19, 2016
• Last updated: January 19, 2016
• Start date: July 2014
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Country: None
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16513
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	Characteristics of NVAF patients newly treated with VKA who experience bleeding events		Up to 24 months after initial treatment with VKA	No
Secondary	Characteristics of NVAF patients newly treated with VKA who do not experience bleeding events		Up to 24 months after initial treatment with VKA	No

External Links

•   BMS Clinical Trials Disclosure
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