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

NCT ID: NCT02447341

Last Updated: 2017-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

987 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2017-01-31

Brief Summary

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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

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Conditions

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Anticoagulation, Blood Thinners , Atrial Fibrillation, Bleeding, Stroke

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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In patients

No interventions assigned to this group

Out patients

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Barcelona, , Spain

Site Status

Countries

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Spain

Related Links

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Other Identifiers

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CV185-372

Identifier Type: -

Identifier Source: org_study_id

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