Overview

This trial is active, not recruiting.

Condition anticoagulation
Treatments apixaban, rivaroxaban, dabigatran
Sponsor Bristol-Myers Squibb
Collaborator Pfizer
Start date December 2015
End date November 2016
Trial size 40900 participants
Trial identifier NCT02921126, CV185-494

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
Apixaban - 10 mg/day Rivaroxaban - 20 mg/day Dabigatran - 300 mg/day
apixaban
rivaroxaban
dabigatran
Apixaban - 5 mg/day Rivaroxaban - 15 mg/day Dabigatran - 220 mg/day
apixaban
rivaroxaban
dabigatran
Invalid Doses / Off-Label
apixaban
rivaroxaban
dabigatran

Primary Outcomes

Measure
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

Measure
Distribution of patient demographics at the time of OAC initiation
time frame: at baseline
Distribution of clinical characteristics at the time of OAC initiation
time frame: at baseline
Composite of number and percentage of patients who are persistent with their newly prescribed OAC
time frame: Approximately 30 months
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
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Real-World Evidence of Anticoagulation Treatment In Non-Valvular Atrial Fibrillation In Italy
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.