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

NCT02661516 | Completed

• 1 other identifier: CV185-338
• Study Type: observational
• Target: 16,513
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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

• 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

Study Arms (1)

Vitamin K Antagonists

Vitamin K Antagonists dose as specified

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Related Links

• Investigator Inquiry form

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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: July 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 22, 2016

Record last verified: 2016-01