Evaluation of Safety and Effectiveness on Oral Anticoagulants

NCT03765242

Last updated date
Study Location
Local Institution
Minato-ku, Tokyo, 1080074, Japan
Contact
1-800-718-1021

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

- Individuals greater than or equal to 20 years old as of the index date

- At least 1 diagnosis of NVAF prior to or on index date, identified by any medical records

- Newly treated with warfarin or apixaban between 01-Jan-2011 to 31-Dec-2016. The first warfarin or apixaban prescription date during the identification period will be designated as the index date

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


- Patient's medical records indicating pregnancy during the follow-up period


- Patient's medical records indicating taking warfarin, apixaban, dabigatran,
rivaroxaban, or edoxaban during the 6-months prior to the index date


- Had > 1 OAC prescription in the patient's medical records on the index date


Other protocol defined inclusion/exclusion criteria could apply

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Advanced Information
Descriptive Information
Brief Title Evaluation of Safety and Effectiveness on Oral Anticoagulants
Official Title Retrospective Medical Chart Review Study for Atrial Fibrillation Patents Treated With Oral Anticoagulant
Brief Summary This study is to compare the risk of major bleeding among oral anticoagulant (OAC)-naïve non-valvular atrial fibrillation (NVAF) patients initiating treatment
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 Probability Sample
Study Population Patients' medical charts with newly initiating warfarin or apixaban within the identification period fulfilling the study eligibility criteria
Condition Atrial Fibrillation
Intervention Other: Non-Interventional
Non-Interventional
Study Groups/Cohorts
  • Patient initiating warfarin
    Intervention: Other: Non-Interventional
  • Patient initiating apixaban
    Intervention: Other: Non-Interventional
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 Active, not recruiting
Estimated Enrollment
 (submitted: December 4, 2018)
12000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 29, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Individuals greater than or equal to 20 years old as of the index date
  • At least 1 diagnosis of NVAF prior to or on index date, identified by any medical records
  • Newly treated with warfarin or apixaban between 01-Jan-2011 to 31-Dec-2016. The first warfarin or apixaban prescription date during the identification period will be designated as the index date

Exclusion Criteria:

  • Patient's medical records indicating pregnancy during the follow-up period
  • Patient's medical records indicating taking warfarin, apixaban, dabigatran, rivaroxaban, or edoxaban during the 6-months prior to the index date
  • Had > 1 OAC prescription in the patient's medical records on the index date

Other protocol defined inclusion/exclusion criteria could apply

Sex/Gender
Sexes Eligible for Study:All
Ages 20 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 Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03765242
Other Study ID Numbers CV185-698
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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 December 2018