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CompletedNCT02858518PREDIC-AGEUpdated Jan 23, 2017

Risk of Bleeding and Anticoagulation in Atrial Fibrillation: What Predictive Criterion Used?

An observational study in Atrial Fibrillation and Gerontology, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Completed at 5 sites in France. Open to participants aged 80 Years and older. Per ClinicalTrials.gov, last updated 2017-01-23.

Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
80 Years and older
Sex
All
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Study summary

Atrial fibrillation (AF) is a rhythmic cardiac activity disorder disturbing hemodynamic blood flow. It is a public health problem with 600,000 to 1 million people involved in France which 2/3 are aged over 75 years. a FA untreated exposes the patient to a significant risk of embolism responsible for a rate stroke (stroke) ischemic estimated at 85%. The anticoagulant standard treatment helps prevent the occurrence of this complication.

However, oral anticoagulation also exposes patients to an increased risk of bleeding. The bleeding risk can be assessed using scales: several being proposed (HEMORR2HAGES, HAS-BLED, ATRIA and scores Shireman and Charlson ...).

moreover, in geriatric hospital care, every patient has a "standardized geriatric assessment" to assess and quantify functional capacity, autonomy, cognitive abilities, nutritional status, psychological state and its environment social.

Thus, the objective of the investigators study was to determine the frequency of each item of each bleeding risk assessment score and geriatric assessment in patients 80 and older hospitalized geriatric ward in the department and with anticoagulant.

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Conditions studied

  • Atrial Fibrillation
  • Gerontology

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Keywords

  • anticoagulant
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In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's enrollment of 120 is below the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 578 studies on the registry; 128 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
80 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients seniors with atrial fibrillation with anticoagulant treatment

Inclusion criteria

  • hospitalisation in geriatric unit
  • Atrial fibrillation treated by anticoagulant treatment (AVK or oral anticoagulation)
  • signed inform consent

Exclusion criteria

Exclusion Criteria:

  • estimated lifetime less than 6 months
  • under guardianship or curatorship
  • without support person
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • patients with atrial fibrillation with anticoagulant treatment

    Other: questionnaires

Interventions

  • Otherquestionnaires

    scales : HEMORR2HAGES (hepatics diseases, alcoholism, cancer, thrombocytopenia, anemia and antecedent...), HAS-Bled (arterial hypertension, renal function, liver function, cerebrovascular accident...), ATRIA (anemia, serious kidney diseases, hypertension, antecedent...), Shireman (gender, age, hemorrhage, diabetes, anemia...), Charlson (age, cardiovascular disease, lung disease, neurological disease, endocrinal disease, nephrology, liver disease, gastroenterology, cancer) and standardised geriatric assessment (comorbidities, cognition, mobility, pain, nutrition, living environment...)

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What researchers measure

Primary outcomes

  1. scale : HEMORR2HAGES

    hepatics diseases, alcoholism, cancer, thrombocytopenia, anemia and antecedent...

    Time frame: at baseline

  2. scale : HAS-Bled

    arterial hypertension, renal function, liver function, cerebrovascular accident...

    Time frame: at baseline

  3. scale : ATRIA

    anemia, serious kidney diseases, hypertension, antecedent...

    Time frame: at baseline

  4. scale : shireman

    gender, age, hemorrhage, diabetes, anemia...

    Time frame: at baseline

  5. scale charlson

    age, cardiovascular disease, lung disease, neurological disease, endocrinal disease, nephrology, liver disease, gastroenterology, cancer

    Time frame: at baseline

  6. scale : standardised geriatric assessment

    comorbidities, cognition, mobility, pain, nutrition, living environment...

    Time frame: at baseline

Secondary outcomes

  1. Occurrence of major bleeding event or not major

    Time frame: at baseline and 6 months

  2. genotyping

    CYP2C9

    Time frame: at baseline

  3. genotyping

    VKCRC1

    Time frame: at baseline

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Study locations

5 sites
  • CH de FEURS
    Feurs, 42110, France
  • CH de FIRMINY
    Firminy, 42700, France
  • CH de ROANNE
    Roanne, 42300, France
  • CH de SAINT-CHAMOND
    Saint-chamond, 42400, France
  • CHU de SAINT-ETIENNE
    Saint-etienne, 42000, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02858518
Lead sponsor
Centre Hospitalier Universitaire de Saint Etienne
Responsible party
Sponsor
First posted
Aug 8, 2016
Start date
Mar 2015
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Jan 23, 2017

Study contacts

Emilie CRAWFORD-ACHOUR, MD
principal investigator · CHU de SAINT-ETIENNE

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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