Profile and Antithrombotic Management of Patients With NVAF Attending Internal Medicine Departments in Spain (PERFILAR Study)

Multicenter Observational Study to Determine the Profile and Antithrombotic Management of Patients With Nonvalvular Atrial Fibrillation Attending Internal Medicine Departments in Spanish Hospitals (Perfilar Study)

This is a national, multicenter, cross-sectional, observational study within a convenience sample of Internal Medicine departments from 100 hospitals in Spain which agree to participate in the study. This study will be a cross-sectional chart review which will require the collection of data from medical records and from face-to-face interviews conducted during the inclusion visit. Physician interviews are needed to collect three variables of interest, recommended by the Spanish Society of Internal Medicine as necessary data about profile and management of NVAF patients: cognitive deterioration based on the patient's responses, physician's assessment of the patient's life expectancy, and physician's opinion of the antithrombotic treatment previously prescribed. The investigators will only provide their opinion on previously prescribed therapies (i.e. prescribed before F2F). Hospitals to be contacted for the study include those known to participate in observational studies in Spain; the hospitals will therefore not be a random sample of Spanish hospitals.

Study Overview

• Status: Completed
• Conditions: Anticoagulation, Blood Thinners , Atrial Fibrillation, Bleeding, Stroke

• Study Type: Observational
• Enrollment (Actual): 987

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08027
    • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients with NVAF

Description

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Adult patients (≥18 years old)
• Patients diagnosed with Non-valvular atrial fibrillation (NVAF) any time prior to the inclusion date (prevalent or incident patients)
• Patients treated or not treated with an antithrombotic therapy
• Treated patients should have begun treatment prior to the inclusion visit
• Patients attending Internal Medicine departments, either for a hospital appointment (outpatients) or hospitalization (inpatients) for any reason)
• Patients which signed the informed consent

Exclusion Criteria:

• Patients diagnosed with valvular atrial fibrillation any time in their medical records
• Patients with anticoagulant treatment prescribed for venous thromboembolic disease any time prior to the inclusion date
• Patients which participated in any clinical trial with anticoagulant and/or antiplatelet agents in the previous six months
• Patients incapable of giving their informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
In patients
Out patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Demographics (age, sex, living environment) of patients with NVAF attending Spanish hospitals by antithrombotic treatment type (including absence of treatment)	Approximately 6 months
Clinical characteristics (bleeding, myocardial infarction, stroke) of patients with NVAF attending Spanish hospitals by antithrombotic treatment type (including absence of treatment)	Approximately 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Characteristics (bleeding, myocardial infarction, stroke) associated with the administration of oral antithrombotic treatments	Clinical Characteristics (bleeding, myocardial infarction, stroke) associated with the administration of oral antithrombotic treatments (i.e.Vitamin K Antagonists (VKAs), New Oral Anticoagulants (NOACs), antiplatelet drugs, or combinations of anticoagulant and antiplatelet drugs	Approximately 6 months
Estimating the rate of compliance to treatment and by calculating the proportion of patients treated in accordance with guidelines among the patients treated with oral anticoagulants	Evaluate current clinical practice in Internal Medicine departments in Spanish hospitals according to the European Guidelines by estimating the rate of compliance to treatment; and by calculating the proportion of patients treated in accordance with guidelines among the patients treated with oral anticoagulants	Approximately 6 months

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS clinical trial educational resource

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: May 5, 2015
• First Submitted That Met QC Criteria: May 14, 2015
• First Posted (Estimate): May 18, 2015

Study Record Updates

• Last Update Posted (Actual): May 17, 2017
• Last Update Submitted That Met QC Criteria: May 15, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: CV185-372