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OpenTrials
Completed

NCT Number: NCT02661516

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

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).

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Impact of bleeding events on the risk of subsequent clinical events including subsequent bleeds assessed based on hazard ratios

    Time frame: Up to 24 months after initial treatment with VKA

  2. Impact of bleeding events on the rate of health-care resource utilization (HCRU) assessed based on incidence rate ratios

    Time frame: Up to 24 months after initial treatment with VKA

  3. 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

    Time frame: Up to 24 months after initial treatment with VKA

Secondary outcomes

  1. 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

    Time frame: Upto 24 months after initial treatment with VKA

  2. Characteristics of NVAF patients newly treated with VKA who experience bleeding events

    Time frame: Up to 24 months after initial treatment with VKA

  3. Characteristics of NVAF patients newly treated with VKA who do not experience bleeding events

    Time frame: Up to 24 months after initial treatment with VKA

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 22, 2016
Registry last updated
Jan 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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