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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)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02447341
Enrollment
987
Registered
2015-05-18
Start date
2015-03-31
Completion date
2017-01-31
Last updated
2017-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anticoagulation, Blood Thinners , Atrial Fibrillation, Bleeding, Stroke

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.

Interventions

None listed

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime 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

MeasureTime frameDescription
Clinical Characteristics (bleeding, myocardial infarction, stroke) associated with the administration of oral antithrombotic treatmentsApproximately 6 monthsClinical 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
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 monthsEvaluate 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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026