Bleeding Events and Oral Anticoagulant Treatment in Non-Valvular Atrial Fibrillation

NCT03002740

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-valvular Atrial Fibrillation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Have a prescription for apixaban, rivaroxaban, dabigatran, or VKA during the study period

2. Are ≥ 18 years of age at index date

3. Have ≥ 12 months of computerised medical data prior to index date (date of OAC initiation)

4. Have a record of AF on or ever prior to index date

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


1. Have a record for a valvular condition that is considered causal for AF on or ever
prior to index date


2. Have a history of the OACs which are prescribed during the study period (ie, history
of index OAC, as patients need to be newly prescribed either apixaban, rivaroxaban,
dabigatran, or VKA)


3. Have more than 1 OAC exposure which starts on the same date

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Advanced Information
Descriptive Information
Brief Title Bleeding Events and Oral Anticoagulant Treatment in Non-Valvular Atrial Fibrillation
Official Title Bleeding Events and Oral Anticoagulant Treatment in Non-Valvular Atrial Fibrillation (Heart-BEAT): A Cohort Study Based on CPRD-HES Data
Brief Summary In a population of patients with non-valvular atrial fibrillation (NVAF), and treated with oral anticoagulants (OAC) in routine clinical practice in England, this study will describe patients treated with each OAC, and to estimate and compare event rates of treatment discontinuation, bleeding, and healthcare resource utilisation (HCRU) across OAC treatments.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adults with NVAF recorded in the UK Clinical Practice Research Datalink(CPRD) and Hospital Episode Statistics(HES) database, and who were newly prescribed with apixaban, rivaroxaban, dabigatran or VKA from 1st December 2012 and 31st December 2015 (or up to the most recent data available).
Condition Non-valvular Atrial Fibrillation
Intervention Not Provided
Study Groups/Cohorts
  • NVAF patients newly prescribed apixaban
  • NVAF patients newly prescribed rivaroxaban
  • NVAF patients newly prescribed dabigatran
  • NVAF patients newly prescribed VKA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: October 9, 2018)
0
Original Estimated Enrollment
 (submitted: December 21, 2016)
21300
Estimated Study Completion Date August 31, 2018
Estimated Primary Completion Date August 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Have a prescription for apixaban, rivaroxaban, dabigatran, or VKA during the study period
  2. Are ? 18 years of age at index date
  3. Have ? 12 months of computerised medical data prior to index date (date of OAC initiation)
  4. Have a record of AF on or ever prior to index date

Exclusion Criteria:

  1. Have a record for a valvular condition that is considered causal for AF on or ever prior to index date
  2. Have a history of the OACs which are prescribed during the study period (ie, history of index OAC, as patients need to be newly prescribed either apixaban, rivaroxaban, dabigatran, or VKA)
  3. Have more than 1 OAC exposure which starts on the same date
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03002740
Other Study ID Numbers CV185-491
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor Bristol-Myers Squibb
Collaborators Pfizer
Investigators
Study Director:Bristol-Myers SquibbBristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date September 2018