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

Anticoagulation Clinical Trial

— RE-FIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02921126
• Other study ID #: CV185-494
• Status: Completed
• Start date: April 30, 2017
• Est. completion date: August 2, 2018

Study information

• Verified date: August 2018
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9914
• Est. completion date: August 2, 2018
• Est. primary completion date: August 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anticoagulation
• Atrial Fibrillation

Locations

Country	Name	City	State
Italy	Local Institution	Ravenna

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Pfizer

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Distribution of patient demographics at the time of OAC initiation		at baseline
Secondary	Distribution of clinical characteristics at the time of OAC initiation		at baseline
Secondary	Composite of number and percentage of patients who are persistent with their newly prescribed OAC		Approximately 30 months
Secondary	Incidence of major bleeding events following treatment initiation among NVAF patients following treatment initiation on an oral OAC in Italy		Approximately 30 months
Secondary	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

External Links

•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form