Clinical trial NCT02447341: Profile and Antithrombotic Management of Patients With NVAF Attending Internal Medicine Departments in Spain (PERFILAR Study)
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anticoagulation, Blood Thinners , Atrial Fibrillation, Bleeding, Stroke
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2015-05-18
Enrollment: 987
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients with NVAF

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.


Eligibility 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

Primary outcomes:
measure: Demographics (age, sex, living environment) of patients with NVAF attending Spanish hospitals by antithrombotic treatment type (including absence of treatment)
timeFrame: Approximately 6 months
measure: Clinical characteristics (bleeding, myocardial infarction, stroke) of patients with NVAF attending Spanish hospitals by antithrombotic treatment type (including absence of treatment)
timeFrame: Approximately 6 months
Secondary outcomes:
measure: Clinical Characteristics (bleeding, myocardial infarction, stroke) associated with the administration of oral antithrombotic treatments
timeFrame: Approximately 6 months
measure: 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
timeFrame: Approximately 6 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: