check_circleStudy Completed

Stroke, prevention and control, Atrial fibrillation

Bayer Identifier:

17964

ClinicalTrials.gov Identifier:

NCT02470767

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

Trial purpose

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)

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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.

  • - 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.

Trial summary

Enrollment Goal
792
Trial Dates
May 2015 - March 2016
Phase
N/A
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Spain

Primary Outcome

  • Composite of demographic characteristics: age, gender and race
    sociodemographic data
    date_rangeTime Frame:
    At baseline visit
    enhanced_encryption
    Safety Issue:
    No
  • Composite of relevant cardiovascular events: stroke, TIA, systemic embolism, bleeding
    clinical characteristics
    date_rangeTime Frame:
    At baseline visit
    enhanced_encryption
    Safety Issue:
    Yes
  • Composite of comorbidities: hypertension, heart failure, diabetes mellitus, kidney failure, dyslipidemia,
    clinical characteristics
    date_rangeTime Frame:
    At baseline visit
    enhanced_encryption
    Safety Issue:
    Yes
  • Data 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: relevant active substances
    clinical characteristics
    date_rangeTime Frame:
    At baseline visit
    enhanced_encryption
    Safety Issue:
    Yes
  • Risk of thromboembolic event based on the CHADS2 score
    clinical characteristics
    date_rangeTime Frame:
    At baseline visit
    enhanced_encryption
    Safety Issue:
    Yes
  • Risk of thromboembolic event based on the CHA2DS2-VASc score
    clinical characteristics
    date_rangeTime Frame:
    At baseline visit
    enhanced_encryption
    Safety Issue:
    Yes
  • Risk of bleeding based on the HAS-BLED score
    clinical characteristics
    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
    use of ACTS questionnaire
    date_rangeTime Frame:
    At baseline visit
    enhanced_encryption
    Safety Issue:
    No
  • Reason of the change in treatment: according to Spanish guideline for the SPAF management: IPT (Informe de Posicionamiento Terapeutico)
    use IPT guideline
    date_rangeTime Frame:
    At baseline visit
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
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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