Real-World Evidence of Anticoagulation Treatment In Non-Valvular Atrial Fibrillation In Italy

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NCT02921126

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Study Location
Local Institution
Ravenna, , 48121, Italy
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Anticoagulation
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

- are at least 18 years of age at index date

- Initiated new OAC therapy ( no previous prescriptions of the same index OAC in the last 12 months prior to the index date ) during the study period

- Had at least 1 claim with diagnosis of AF anytime in their records

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


- Have a record that is indicative of Valvular Atrial Fibrillation during this period


- Have a history of the OACs prescribed during the study period as assessed during the
period of data availability(i.e. history of index OAC, as patients need to be newly
prescribed either apixaban, rivaroxaban, dabigatran or VKA)


- Have more than one OAC exposure which starts on the same date

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Advanced Information
Descriptive Information
Brief Title Real-World Evidence of Anticoagulation Treatment In Non-Valvular Atrial Fibrillation In Italy
Official Title Real-World Evidence of Anticoagulation Treatment In Non-Valvular Atrial Fibrillation In Italy
Brief Summary To quantify rates of bleeding events and investigate the characteristics of prescribed patients, rates of bleeding events, persistence and healthcare resource utilization of Oral Anticoagulants (OACs) prescribed in routine clinical practice.
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 The study will include adults with NVAF who are newly prescribed apixaban, rivaroxaban, dabigatran, and VKA in 10 Italian Local Health Units (LHUs), during the study period, and meet the inclusion and exclusion criteria.
Condition Anticoagulation
Intervention Not Provided
Study Groups/Cohorts
  • High Dose Group
    Apixaban - 10 mg/day Rivaroxaban - 20 mg/day Dabigatran - 300 mg/day
  • Low Dose Group
    Apixaban - 5 mg/day Rivaroxaban - 15 mg/day Dabigatran - 220 mg/day
  • Other Dose Group
    Invalid Doses / Off-Label
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 Completed
Actual Enrollment
 (submitted: August 7, 2018)		9914
Original Estimated Enrollment
 (submitted: September 29, 2016)		40900
Actual Study Completion Date August 2, 2018
Actual Primary Completion Date August 2, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • are at least 18 years of age at index date
  • Initiated new OAC therapy ( no previous prescriptions of the same index OAC in the last 12 months prior to the index date ) during the study period
  • Had at least 1 claim with diagnosis of AF anytime in their records

Exclusion Criteria:

  • Have a record that is indicative of Valvular Atrial Fibrillation during this period
  • Have a history of the OACs prescribed during the study period as assessed during the period of data availability(i.e. history of index OAC, as patients need to be newly prescribed either apixaban, rivaroxaban, dabigatran or VKA)
  • Have more than one 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 Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT02921126
Other Study ID Numbers CV185-494
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 August 2018