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

Completed

• Conditions: Stroke; Atrial Fibrillation; Prevention and Control
• Interventions: Drug: Direct Oral Anticoagulant (DOAC)

• Registration Number: NCT02470767
• Lead Sponsor: Bayer

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-19
• Study First Submitted QC: 2015-06-10
• Study First Posted: 2015-06-12
• Primary Completion: 2015-12
• Study Completion: 2016-03
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-15
• Last Update Posted: 2017-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 792

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DOAC treated patients	Direct Oral Anticoagulant (DOAC)	Patients diagnosed with Non-Valvular Atrial Fribilation at risk of stroke or systemic embolism treated in primary care centres with DOAC.

Primary Outcome Measures

Name	Time	Method
Composite of demographic characteristics: age, gender and race	At baseline visit	sociodemographic data
Composite of relevant cardiovascular events: stroke, TIA, systemic embolism, bleeding	At baseline visit	clinical characteristics
Composite of comorbidities: hypertension, heart failure, diabetes mellitus, kidney failure, dyslipidemia,	At baseline visit	clinical characteristics
Data on the Non-Valvular Atrial Fibrillation treatment: relevant active substances	At baseline visit	clinical characteristics
Concomitant treatments: relevant active substances	At baseline visit	clinical characteristics
Risk of thromboembolic event based on the CHADS2 score	At baseline visit	clinical characteristics
Risk of thromboembolic event based on the CHA2DS2-VASc score	At baseline visit	clinical characteristics
Risk of bleeding based on the HAS-BLED score	At baseline visit	clinical characteristics

Secondary Outcome Measures

Name	Time	Method
Adherence to treatment	At baseline visit	use of Haynes-Sackett test
Satisfaction of treatment	At baseline visit	use of ACTS questionnaire
Reason of the change in treatment: according to Spanish guideline for the SPAF management: IPT (Informe de Posicionamiento Terapeutico)	At baseline visit	use IPT guideline