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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02921126

Acronym

RE-FIT

Enrollment

9914

Registered

2016-10-03

Start date

2017-04-30

Completion date

2018-08-02

Last updated

2018-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anticoagulation

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Incidence of clinically relevant bleeding events among Non-valvular atrial fibrillation (NVAF) patients following treatment initiation on an oral OAC in Italy	Approximately 30 months

Secondary

Measure	Time frame
Distribution of patient demographics at the time of OAC initiation	at baseline
Distribution of clinical characteristics at the time of OAC initiation	at baseline
Composite of number and percentage of patients who are persistent with their newly prescribed OAC	Approximately 30 months
Incidence of major bleeding events following treatment initiation among NVAF patients following treatment initiation on an oral OAC in Italy	Approximately 30 months
Composite of number and percentage of patients with major bleeding events, thromboembolic events, or death while exposed to the newly prescribed OAC	Approximately 30 months

Countries

Italy

Outcome results