Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02447341
Recruitment Status : Completed
First Posted : May 18, 2015
Last Update Posted : May 17, 2017
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
Anticoagulation, Blood Thinners , Atrial Fibrillation, Bleeding, Stroke

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 987 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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 Start Date : March 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
In patients
Out patients


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients with NVAF
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02447341


Locations
Layout table for location information
Spain
Local Institution
Barcelona, Spain, 08027
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Layout table for investigator information
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02447341    
Other Study ID Numbers: CV185-372
First Posted: May 18, 2015    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes