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

Completed
Conditions
Anticoagulation, Blood Thinners , Atrial Fibrillation, Bleeding, Stroke
Registration Number
NCT02447341
Lead Sponsor
Bristol-Myers Squibb
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
987
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
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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
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
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 anticoagulantsApproximately 6 months

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

Clinical Characteristics (bleeding, myocardial infarction, stroke) associated with the administration of oral antithrombotic treatmentsApproximately 6 months

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

Trial Locations

Locations (1)

Local Institution

🇪🇸

Barcelona, Spain

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