Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06420011
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-03-04
Brief Title:
FAITH - Factor XA Inhibitor-Related InTracranial Haemorrhage
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Real-World Observational Multicentre Retrospective Analysis to Evaluate the Clinical Characteristics Medical Management and Outcomes of Hospitalised Patients With Factor XA Inhibitor-Related InTracranial Haemorrhage FAITH
Status:
RECRUITING
Status Verified Date:
2024-09
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:
FAITH
Brief Summary:
FAITH study is a multicentre retrospective analysis study that aims to understand the burden of ICH related to FXa inhibitors and the current treatment approaches in countrycountries where specific reversal agents are not available yet The results of this analysis will improve our understanding of FXa inhibitor-related ICH its socioeconomic impact and factors associated with negative outcomes in real-world settings The insights gained can inform clinical decision making and potentially lead to strategies to optimise the use of FXa inhibitors increase the availability of specific reversal agents and improve patient safety and outcomes
Detailed Description:
FAITH is a retrospective non-interventional multicentre cohort study that will retrieve the data from medical records of adult patients who were hospitalised with confirmed diagnosis of ICH while being treated with FXa inhibitors The primary objectives of the study is to describe the characteristics and hospital outcomes of hospitalised patients with FXa inhibitors-related ICH in real-world settings Data of consecutive patients admitted on or after 1 January 2021 and by 30 June 2023 will be retrieved The index date is defined as the date of hospital admissionThe identification of ICH will be based on the CTMRI scan records and according to the ICD-10-CM diagnosis code To establish the causal relation between FXa and ICH the study will include only patients who were determined in the medical records to have taken oral FXa inhibitorsThe historical data will be followed up from the index date the date of hospital admission until the earliest date of death lost to follow-up or up to 6 monthsThe 6-month follow-up period will allow for the assessment of the disability rate and the need for supportive care among survivors
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