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Real-World Evidence of Anticoagulation Treatment In Non-Valvular Atrial Fibrillation In Italy (RE-FIT)

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status

Completed

Conditions

Anticoagulation

Study type

Observational

Funder types

Industry

Identifiers

NCT02921126
CV185-494

Details and patient eligibility

About

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.

Enrollment

9,914 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

9,914 participants in 3 patient groups

High Dose Group
Description:
Apixaban - 10 mg/day Rivaroxaban - 20 mg/day Dabigatran - 300 mg/day
Low Dose Group
Description:
Apixaban - 5 mg/day Rivaroxaban - 15 mg/day Dabigatran - 220 mg/day
Other Dose Group
Description:
Invalid Doses / Off-Label

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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