Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-03-06 @ 7:57 AM
Study NCT ID:
NCT02886533
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2016-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Major Bleeding Risk Associated With Antithrombotics
Sponsor:
Rennes University Hospital
Organization:
Study Overview
Official Title:
Major Bleeding Risk Associated With Antithrombotics : The SACHA (Surveillance Des Accidents Hémorragiques Graves Sous Antithrombotiques) Study
Status:
COMPLETED
Status Verified Date:
2017-02
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:
SACHA
Brief Summary:
Prospective, multicenter, observational study with a three-year inclusion period (from January 1, 2012 to December 31, 2015) and a 6-month follow-up
Detailed Description:
All adults subjects living in the five well-defined areas affiliated to the French National Health Insurance System and having had at least one reimbursement of any antithrombotic in the 3-year study period are identified by using data from the National Health reimbursement database (Système National d'Information Inter-Régimes de l'Assurance Maladie, SNIIR-AM). SNIIR-AM contains individualized, anonymous and comprehensive data for all health spending reimbursements of affiliated subjects, including basic patient demographic data, medical drugs as well as outpatient medical care, prescribed or performed by health-care professionals from both public and private practices. This allows to calculate a denominator (number of person-years of anti-thrombotic drug exposure).
Crude incidence rates of major bleeding per 100 person-months are calculated in antithrombotic users, anticoagulants and others; stratification on a modified HAS-BLED score allows fair comparison between anti-thrombotic drug classes.
Crude incidence rates of major bleeding per 100 person-months are calculated in antithrombotic users, anticoagulants and others; stratification on a modified HAS-BLED score allows fair comparison between anti-thrombotic drug classes.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: