Atrial FibrillationPREDIC-AGENCT02858518
Risk of Bleeding and Anticoagulation in Atrial Fibrillation: What Predictive Criterion Used?
An observational study of Atrial Fibrillation and Gerontology, run by Centre Hospitalier Universitaire de Saint Etienne at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Atrial Fibrillation, Gerontology
- What is being tested?
- questionnaires
- How many people
- 120 participants
- Where
- 5 sitesFrance
- Study dates
- Mar 2015to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: patients seniors with atrial fibrillation with anticoagulant treatment
Who may be able to join
- hospitalisation in geriatric unit
- Atrial fibrillation treated by anticoagulant treatment (AVK or oral anticoagulation)
- signed inform consent
Who cannot join
- estimated lifetime less than 6 months
- under guardianship or curatorship
- without support person
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CH de FEURS
Feurs, 42110
CH de FIRMINY
Firminy, 42700
CH de ROANNE
Roanne, 42300
CH de SAINT-CHAMOND
Saint-Chamond, 42400
CHU de SAINT-ETIENNE
Saint-Etienne, 42000
About this study
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 ...).
Read more
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.
- Conditions
- Atrial Fibrillation, Gerontology
- Being tested
- questionnaires
- Keywords
- anticoagulant
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesOther
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...)
| Study group | Role | What they receive |
|---|---|---|
| patients with atrial fibrillation with anticoagulant treatment | Not described Receives: Other: questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
scale : HEMORR2HAGES
hepatics diseases, alcoholism, cancer, thrombocytopenia, anemia and antecedent...
Measured: at baseline
scale : HAS-Bled
arterial hypertension, renal function, liver function, cerebrovascular accident...
Measured: at baseline
scale : ATRIA
anemia, serious kidney diseases, hypertension, antecedent...
Measured: at baseline
scale : shireman
gender, age, hemorrhage, diabetes, anemia...
Measured: at baseline
scale charlson
age, cardiovascular disease, lung disease, neurological disease, endocrinal disease, nephrology, liver disease, gastroenterology, cancer
Measured: at baseline
scale : standardised geriatric assessment
comorbidities, cognition, mobility, pain, nutrition, living environment...
Measured: at baseline
Secondary outcomes (3)
Occurrence of major bleeding event or not major
Measured: at baseline and 6 months
genotyping
CYP2C9
Measured: at baseline
genotyping
VKCRC1
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study startMar 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilie CRAWFORD-ACHOUR, MD, Principal investigator, CHU de SAINT-ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02858518
- Sponsor's protocol ID
- 1408020
- Other IDs
- 2014-A01664-43
- Acronym
- PREDIC-AGE
- Status last verified
- Aug 2016
- First submitted
- 1 Aug 2016
- Last updated
- 23 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Bleeding and Anticoagulation in Atrial Fibrillation: What Predictive Criterion Used?
- ClinicalTrials.gov ID
- NCT02858518
- Acronym / sponsor ID
- PREDIC-AGE / 1408020
- Conditions
- Atrial Fibrillation, Gerontology
- Keywords
- anticoagulant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 8 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with atrial fibrillation with anticoagulant treatment | – | Other: questionnaires |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- patients seniors with atrial fibrillation with anticoagulant treatment
Key inclusion criteria (3 listed)
- hospitalisation in geriatric unit
- Atrial fibrillation treated by anticoagulant treatment (AVK or oral anticoagulation)
- signed inform consent
Key exclusion criteria (3 listed)
- estimated lifetime less than 6 months
- under guardianship or curatorship
- without support person
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnairesscales : 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...) | Other | patients with atrial fibrillation with anticoagulant treatment |
Primary outcome
scale : HEMORR2HAGES
Time frame: at baseline
hepatics diseases, alcoholism, cancer, thrombocytopenia, anemia and antecedent...
scale : HAS-Bled
Time frame: at baseline
arterial hypertension, renal function, liver function, cerebrovascular accident...
scale : ATRIA
Time frame: at baseline
anemia, serious kidney diseases, hypertension, antecedent...
scale : shireman
Time frame: at baseline
gender, age, hemorrhage, diabetes, anemia...
scale charlson
Time frame: at baseline
age, cardiovascular disease, lung disease, neurological disease, endocrinal disease, nephrology, liver disease, gastroenterology, cancer
scale : standardised geriatric assessment
Time frame: at baseline
comorbidities, cognition, mobility, pain, nutrition, living environment...
3 secondary outcomes
Occurrence of major bleeding event or not major
Time frame: at baseline and 6 months
genotyping
Time frame: at baseline
genotyping
Time frame: at baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2017.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilie CRAWFORD-ACHOUR, MD principal investigator
CHU de SAINT-ETIENNE
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Gerontology, run by Centre Hospitalier Universitaire de Saint Etienne at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
scale : HEMORR2HAGES (time frame: at baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2017.