check_circleStudy Completed

Stroke, prevention and control, Atrial fibrillation

Bayer Identifier:

17961

ClinicalTrials.gov Identifier:

NCT02559232

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

Trial purpose

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)

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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.


  • - 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 .

Trial summary

Enrollment Goal
247
Trial Dates
September 2015 - March 2016
Phase
Phase 4
Could I Receive a placebo
No
Products
Unspecified
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
many locations, Spain

Primary Outcome

  • Age
    sociodemographic data
    date_rangeTime Frame:
    At baseline visit
    enhanced_encryption
    Safety Issue:
    No
  • Gender
    sociodemographic data
    date_rangeTime Frame:
    At baseline visit
    enhanced_encryption
    Safety Issue:
    No
  • Race
    sociodemographic data
    date_rangeTime Frame:
    At baseline visit
    enhanced_encryption
    Safety Issue:
    No
  • Composite of relevant cardiovascular events: stroke, TIA, systemic embolism, bleeding
    sociodemographic data
    date_rangeTime Frame:
    At baseline visit
    enhanced_encryption
    Safety Issue:
    Yes
  • Composite number of participants with comorbidities: hypertension, heart failure, diabetes mellitus, kidney failure, dyslipidemia
    clinical characteristics
    date_rangeTime Frame:
    At baseline visit
    enhanced_encryption
    Safety Issue:
    Yes
  • Dose on the Non-Valvular Atrial Fibrillation treatment: relevant active substances
    clinical characteristics
    date_rangeTime Frame:
    At baseline visit
    enhanced_encryption
    Safety Issue:
    Yes
  • Frequency on the Non-Valvular Atrial Fibrillation treatment: relevant active substances
    clinical characteristics
    date_rangeTime Frame:
    At baseline visit
    enhanced_encryption
    Safety Issue:
    Yes
  • Duration on the Non-Valvular Atrial Fibrillation treatment: relevant active substances
    clinical characteristics
    date_rangeTime Frame:
    At baseline visit
    enhanced_encryption
    Safety Issue:
    Yes
  • 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
    date_rangeTime Frame:
    At baseline visit
    enhanced_encryption
    Safety Issue:
    Yes
  • Risk of thromboembolic event based on the CHADS2 score
    clinical characteristics; CHADS2: Cardiac failure, Hypertension, Age, Diabetes, Stroke
    date_rangeTime Frame:
    At baseline visit
    enhanced_encryption
    Safety Issue:
    Yes
  • 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
    date_rangeTime Frame:
    At baseline visit
    enhanced_encryption
    Safety Issue:
    Yes
  • 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
    date_rangeTime Frame:
    At baseline visit
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Adherence to treatment
    use of Haynes–Sackett test
    date_rangeTime Frame:
    At baseline visit
    enhanced_encryption
    Safety Issue:
    No
  • Satisfaction of treatment by the mean score on the ACTS (Anti Clot Treatment Scale) questionnaire
    date_rangeTime Frame:
    At baseline visit
    enhanced_encryption
    Safety Issue:
    No
  • Compliance with the criteria in therapeutic positioning report UT/V4/23122013
    In some Spanish regions it is mandatory to accomplish the conditions of the national guideline UT/V4/23122013 regarding the use of direct oral anticoagulant. In that guideline the characteristics of patients candidates to direct oral anticoagulant are explained.
    date_rangeTime Frame:
    At baseline visit
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    Healthcare resources
    date_rangeTime Frame:
    At baseline visit
    enhanced_encryption
    Safety Issue:
    No

Trial design

An observational cross-sectional study evaluating the use of re-sources and the sociodemographic and clinical characteristics of patients diagnosed with NVAF with a risk of stroke or systemic embolism on anticoagulant therapy and treated in primary care centers
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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