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

NCT02470767 | Completed

• 1 other identifier: 17964
• Study Type: observational
• Target: 792
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (8)

• Composite of demographic characteristics: age, gender and race

  sociodemographic data

  At baseline visit

• Composite of relevant cardiovascular events: stroke, TIA, systemic embolism, bleeding

  clinical characteristics

  At baseline visit

• Composite of comorbidities: hypertension, heart failure, diabetes mellitus, kidney failure, dyslipidemia,

  clinical characteristics

  At baseline visit

• Data on the Non-Valvular Atrial Fibrillation treatment: relevant active substances

  clinical characteristics

  At baseline visit

• Concomitant treatments: relevant active substances

  clinical characteristics

  At baseline visit

• Risk of thromboembolic event based on the CHADS2 score

  clinical characteristics

  At baseline visit

• Risk of thromboembolic event based on the CHA2DS2-VASc score

  clinical characteristics

  At baseline visit

• Risk of bleeding based on the HAS-BLED score

  clinical characteristics

  At baseline visit

Secondary Outcomes (3)

• Adherence to treatment

  At baseline visit

• Satisfaction of treatment

  At baseline visit

• Reason of the change in treatment: according to Spanish guideline for the SPAF management: IPT (Informe de Posicionamiento Terapeutico)

  At baseline visit

Study Arms (1)

DOAC treated patients

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

Drug: Direct Oral Anticoagulant (DOAC)

Interventions

Direct Oral Anticoagulant (DOAC) DRUG

Treatment pattern following the summary of product characteristics

DOAC treated patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients at risk of stroke or systemic embolism on anticoagulant therapy, who have changed their therapeutic regimen according to their doctor's decision, due to any clinical situation and based on routine clinical practice, and who at the time of enrolment in the study have been receiving treatment with a DOAC for at least three months

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Many Locations, Spain

Location

MeSH Terms

Conditions

Stroke; Atrial Fibrillation

Interventions

N(4)-oleylcytosine arabinoside

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2015
• First Posted: June 12, 2015
• Study Start: May 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2016
• Last Updated: February 16, 2017

Record last verified: 2017-02

Locations

ES (1)