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

NCT02921126 | Completed

• 1 other identifier: CV185-494
• Study Type: observational
• Target: 9,914
• Locations: 1 country
• Sites: 1

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.

Conditions

Anticoagulation

Outcome Measures

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

  Approximately 30 months

Secondary Outcomes (5)

• 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

Study Arms (3)

High Dose Group

Apixaban - 10 mg/day Rivaroxaban - 20 mg/day Dabigatran - 300 mg/day

Low Dose Group

Apixaban - 5 mg/day Rivaroxaban - 15 mg/day Dabigatran - 220 mg/day

Other Dose Group

Invalid Doses / Off-Label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will include adults with NVAF who are newly prescribed apixaban, rivaroxaban, dabigatran, and VKA in 10 Italian Local Health Units (LHUs), during the study period, and meet the inclusion and exclusion criteria.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• Pfizer: collaborator

Study Sites (1)

Local Institution

Ravenna, 48121, Italy

Location

Related Links

• Investigator Inquiry Form

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2016
• First Posted: October 3, 2016
• Study Start: April 30, 2017
• Primary Completion: August 2, 2018
• Study Completion: August 2, 2018
• Last Updated: August 8, 2018

Record last verified: 2018-08

Locations

IT (1)