An Observational Cross-sectional Study Evaluating the Sociodemographic and Clinical Characteristics of Patients Diagnosed With NVAF With a Risk of Stroke or Systemic Embolism, Who Are on Treatment to Adequately Control Their Coagulation and Treated in Primary Care Centres

NCT ID: NCT02470767

Last Updated: 2017-02-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 792 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-03-31

Brief Summary

describe the sociodemographic and clinical characteristics of patients diagnosed with non-valvular atrial fibrillation (NVAF) at risk of stroke or systemic embolism on anticoagulant therapy who have changed their therapeutic regimen, due to any clinical situation, based on the doctor's routine clinical practice and are currently on treatment with a direct oral anticoagulant (DOAC)

Conditions

Stroke; Prevention and Control; Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

DOAC treated patients

Patients diagnosed with Non-Valvular Atrial Fribilation at risk of stroke or systemic embolism treated in primary care centres with DOAC.

Direct Oral Anticoagulant (DOAC)

Intervention Type: DRUG

Treatment pattern following the summary of product characteristics

Interventions

Direct Oral Anticoagulant (DOAC)

Treatment pattern following the summary of product characteristics

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients ≥18 years of age diagnosed with NVAF with a risk of stroke or systemic embolism treated in primary care centres.
• Patients on regular treatment with anticoagulants who have changed their ther-apeutic regimen due to any clinical situation and have been on treatment with a DOAC for at least three months before being recruited (date of signing the in-formed consent).
• Patients whose DOAC has been indicated by the primary care physician.
• Patients who have given their informed consent in writing.

Exclusion Criteria

• Patients who changed their anticoagulant therapy within a period of less than three months before signing the informed consent.
• Patients with cognitive impairment preventing them from understanding what is written in the patient information sheet or the informed consent, or from per-forming the self-administered questionnaires.
• Patients who started anticoagulant therapy for NVAF with a DOAC.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Many Locations, , Spain

Countries

Spain

Other Identifiers

17964

Identifier Type: -

Identifier Source: org_study_id