An Observational Cross-sectional Study Evaluating the Use of Re-sources and the Sociodemographic and Clinical Characteristics of Patients Diagnosed With Non-valvular Atrial Fibrillation With a Risk of Stroke or Systemic Embolism on Anticoagulant Therapy and Treated in Primary Care Centers

NCT02559232 | Completed

• 1 other identifier: 17961
• Study Type: observational
• Target: 247
• Locations: 1 country
• Sites: 1

Brief Summary

This is a retrospective observational study to describe the sociodemographic and clinical characteristics of patients diagnosed with non-valvular atrial fibrillation (NVAF) at risk of stroke or systemic embolism, who at least three months ago changed their anticoagulant therapy, due to any clinical situation, and are currently on treatment with a direct oral anticoagulant (DOAC)

Conditions

Stroke; Prevention and Control; Atrial Fibrillation

Outcome Measures

Primary Outcomes (12)

• Age

  sociodemographic data

  At baseline visit

• Gender

  sociodemographic data

  At baseline visit

• Race

  sociodemographic data

  At baseline visit

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

  sociodemographic data

  At baseline visit

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

  clinical characteristics

  At baseline visit

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

  clinical characteristics

  At baseline visit

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

  clinical characteristics

  At baseline visit

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

  clinical characteristics

  At baseline visit

• Concomitant treatments: therapy group of relevant active substances

  clinical characteristics; therapy group of relevant active substances: antiarrhythmics, Angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, β-blockers, dihydropyridine calcium channel blockers, diuretics, hypolipemiant drugs, oral anti-diabetics and human insulin, antiplatelet agents, nonsteroidal anti-inflammatory drugs, Proton-pump inhibitors, others: specify

  At baseline visit

• Risk of thromboembolic event based on the CHADS2 score

  clinical characteristics; CHADS2: Cardiac failure, Hypertension, Age, Diabetes, Stroke

  At baseline visit

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

  clinical characteristics; CHA2DS2-VASc:Cardiac failure, Hypertension, Age ≥75, Diabetes, Stroke -Vascular disease, Age and sex category

  At baseline visit

• Risk of bleeding based on the HAS-BLED score

  clinical characteristics; HAS-BLED: Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly , Drugs/alcohol concomitantly

  At baseline visit

Secondary Outcomes (4)

• Adherence to treatment

  At baseline visit

• Satisfaction of treatment by the mean score on the ACTS (Anti Clot Treatment Scale) questionnaire

  At baseline visit

• Compliance with the criteria in therapeutic positioning report UT/V4/23122013

  At baseline visit

• Use of healthcare resources: Number of visits with primary care physician. Number of visits with specialist, Number of visits with nursing staff, Number of visits to A&E, Number of diagnostic tests in the period when the change was made, related to NVAF.

  At baseline visit

Study Arms (1)

DOAC treated patients

Patients diagnosed with Non-Valvular Atrial Fibrillation 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 non-valvular atrial fibrillation with a risk of stroke or systemic embolism treated in primary care centres.
• Patients on regular treatment with anticoagulants who have changed their therapeutic regimen due to any clinical situation and have been on treatment with a direct oral anticoagulant for at least three months before being recruited (date of signing the in-formed consent).
• Patients whose first direct oral anticoagulant prescription is written by the specialist (cardiologist, haematologist, internist, etc.) and who are followed in primary care.
• 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 non-valvular atrial fibrillation with a direct oral anticoagulant .

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: September 17, 2015
• First Posted: September 24, 2015
• Study Start: September 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)