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

Atrial Fibrillation Clinical Trial

— PREDIC-AGE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02858518
• Other study ID #: 1408020
• Secondary ID: 2014-A01664-43
• Status: Completed
• Phase: N/A
• First received: August 1, 2016
• Last updated: January 20, 2017
• Start date: March 2015
• Est. completion date: December 2016

Study information

• Verified date: August 2016
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 80 Years and older

Eligibility

Inclusion Criteria:

• hospitalisation in geriatric unit

• Atrial fibrillation treated by anticoagulant treatment (AVK or oral anticoagulation)

• signed inform consent

Exclusion Criteria:

• estimated lifetime less than 6 months

• under guardianship or curatorship

• without support person

Related Conditions & MeSH terms

• Atrial Fibrillation
• Gerontology

Intervention

Other:
• questionnaires
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...)

Locations

Country	Name	City	State
France	CH de FEURS	Feurs
France	CH de FIRMINY	Firminy
France	CH de ROANNE	Roanne
France	CH de SAINT-CHAMOND	Saint-chamond
France	CHU de SAINT-ETIENNE	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	scale : HEMORR2HAGES	hepatics diseases, alcoholism, cancer, thrombocytopenia, anemia and antecedent...	at baseline
Primary	scale : HAS-Bled	arterial hypertension, renal function, liver function, cerebrovascular accident...	at baseline
Primary	scale : ATRIA	anemia, serious kidney diseases, hypertension, antecedent...	at baseline
Primary	scale : shireman	gender, age, hemorrhage, diabetes, anemia...	at baseline
Primary	scale charlson	age, cardiovascular disease, lung disease, neurological disease, endocrinal disease, nephrology, liver disease, gastroenterology, cancer	at baseline
Primary	scale : standardised geriatric assessment	comorbidities, cognition, mobility, pain, nutrition, living environment...	at baseline
Secondary	Occurrence of major bleeding event or not major		at baseline and 6 months
Secondary	genotyping	CYP2C9	at baseline
Secondary	genotyping	VKCRC1	at baseline