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

Completed

• Conditions: Anticoagulation

• Registration Number: NCT02921126
• Lead Sponsor: Bristol-Myers Squibb

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 available

Study Timeline

• Study First Submitted: 2016-09-29
• Study First Submitted QC: 2016-09-29
• Study First Posted: 2016-10-03
• Study Start: 2017-04-30
• Status Verified: 2018-08
• Primary Completion: 2018-08-02
• Study Completion: 2018-08-02
• Last Update Submitted: 2018-08-07
• Last Update Posted: 2018-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9914

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Distribution of patient demographics 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
Distribution of clinical characteristics at the time of OAC initiation	at baseline
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

Trial Locations

Locations (1)

Local Institution; 🇮🇹 Ravenna, Italy