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OpenTrials
Completed

NCT Number: NCT02921126

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

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.

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Key information

Conditions

Anticoagulation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Ravenna, 48121, Italy

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Incidence of clinically relevant bleeding events among Non-valvular atrial fibrillation (NVAF) patients following treatment initiation on an oral OAC in Italy

    Time frame: Approximately 30 months

Secondary outcomes

  1. Distribution of patient demographics at the time of OAC initiation

    Time frame: at baseline

  2. Distribution of clinical characteristics at the time of OAC initiation

    Time frame: at baseline

  3. Composite of number and percentage of patients who are persistent with their newly prescribed OAC

    Time frame: Approximately 30 months

  4. Incidence of major bleeding events following treatment initiation among NVAF patients following treatment initiation on an oral OAC in Italy

    Time frame: Approximately 30 months

  5. Composite of number and percentage of patients with major bleeding events, thromboembolic events, or death while exposed to the newly prescribed OAC

    Time frame: Approximately 30 months

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Pfizer

Registry information

Acronym: RE-FIT

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 3, 2016
Registry last updated
Aug 8, 2018

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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