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NCT Number: NCT02447341

Profile and Antithrombotic Management of Patients With NVAF Attending Internal Medicine Departments in Spain (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.

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Key information

Conditions

Anticoagulation, Blood Thinners , Atrial Fibrillation, Bleeding, Stroke Arrhythmias, Cardiac Atrial Fibrillation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Hemorrhage Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Barcelona, 08027, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Demographics (age, sex, living environment) of patients with NVAF attending Spanish hospitals by antithrombotic treatment type (including absence of treatment)

    Time frame: Approximately 6 months

  2. Clinical characteristics (bleeding, myocardial infarction, stroke) of patients with NVAF attending Spanish hospitals by antithrombotic treatment type (including absence of treatment)

    Time frame: Approximately 6 months

Secondary outcomes

  1. Clinical Characteristics (bleeding, myocardial infarction, stroke) associated with the administration of oral antithrombotic treatments

    Time frame: Approximately 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

  2. 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

    Time frame: Approximately 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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)

Important dates

Study start
2015
Primary completion
2015
Study completion
2017
First posted
May 18, 2015
Registry last updated
May 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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