Ignite Creation Date:
2024-05-06 @ 3:17 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04586972
Status:
RECRUITING
Last Update Posted:
2023-01-13
First Post:
2020-09-25
Brief Title:
Safety and Efficacy of Apixaban in Very Old Geriatric Subjects 80 Years With Atrial FIbrillation in a Prospective reAl World Study
Sponsor:
Gérondif
Organization:
Gérondif
Study Overview
Official Title:
Safety and Efficacy of Apixaban in Very Old Geriatric Subjects 80 Years With Atrial FIbrillation in a Prospective reAl World Study
Status:
RECRUITING
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOFIA
Brief Summary:
The main objective of this study is to realize an observational real life study conducted in French geriatric settings to assess safety and efficacy in 80 year-old patients with nonvalvular Atrial fibrillation AF newly treated with Apixaban
Moreover in this geriatric population the adequacy of Apixaban dosage and events bleeding and stroke will be assessed
Moreover in this geriatric population the adequacy of Apixaban dosage and events bleeding and stroke will be assessed
Detailed Description:
It is a muliticentric observational prospective study
This study will be conducted in about 40 geriatric settings in France
The planned duration of the inclusion period is 27 months in each center
The follow-up period starts from inclusion up to one year after inclusion with phone contact or unscheduled visit at 3 6 9 and 12 months
During this follow-up participants physicians will record patients data during visit directly from the patients or their physicians or their families and by phone
The following data will be colllected
At M0 Socio-demographics clinical and biological data embolic risk and emorrhagic risk scorescognitive function number of falls blood pressure nutritional assessment athonomy comorbidities data on anticoagulant therapy treatment discontinuation and clinical evaluation
At M3 M6 M9 and M12 Number of falls all treatment schedule record of major bleeding events record of any other bleeding events record of other serious events record of other non-major events treatment discontinuation and social and medical environment
Only M6 and M12 Renal function both Cockcroft-Gault chronic Kidney Disease epidemiology Collaboration CKD EPI and the four variable modification of Diet in renal Disease equation MDRD
This study will be conducted in about 40 geriatric settings in France
The planned duration of the inclusion period is 27 months in each center
The follow-up period starts from inclusion up to one year after inclusion with phone contact or unscheduled visit at 3 6 9 and 12 months
During this follow-up participants physicians will record patients data during visit directly from the patients or their physicians or their families and by phone
The following data will be colllected
At M0 Socio-demographics clinical and biological data embolic risk and emorrhagic risk scorescognitive function number of falls blood pressure nutritional assessment athonomy comorbidities data on anticoagulant therapy treatment discontinuation and clinical evaluation
At M3 M6 M9 and M12 Number of falls all treatment schedule record of major bleeding events record of any other bleeding events record of other serious events record of other non-major events treatment discontinuation and social and medical environment
Only M6 and M12 Renal function both Cockcroft-Gault chronic Kidney Disease epidemiology Collaboration CKD EPI and the four variable modification of Diet in renal Disease equation MDRD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None