Clinical trial NCT06420011: FAITH - Factor XA Inhibitor-Related InTracranial Haemorrhage
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: InTracranial Haemorrhage
Keywords: Factor XA Inhibitor-Related InTracranial Haemorrhage
FXa
ICH
FAITH
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-05-17
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will recruit 350 adult patients (age ≥18 years at the time of hospital admission) hospitalised patients with FXa inhibitors-related ICH from a total of 20-25 sites from Asia-Pacific Region, Latin America, and the MEA, where FXa inhibitors specific reversal agent is not approved locally.

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 country/countries 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 admission.The identification of ICH will be based on the CT/MRI 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 inhibitors.The 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 months.The 6-month follow-up period will allow for the assessment of the disability rate and the need for supportive care among survivors.

Eligibility criteria: Inclusion Criteria:

* Men and women ≥ 18 years of age at the time of hospital admission.
* Patients presented with a spontaneous or traumatic haemorrhage into any intracranial compartment. The diagnosis of ICH will be based on Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scan and according to the ICD-10-CM diagnosis code.
* Patients who were determined in the medical records to have taken a dose of oral FXa inhibitors within 24 hrs before hospital presentation that warranted reversal of anticoagulant activities.

Exclusion Criteria:

* Patients who were treated with andexanet alfa.
* Patients who were enrolled in any clinical trials during the study period.

Primary outcomes:
measure: Patient characteristics
timeFrame: Index day (Date of hospitalization) to 24hours
measure: Patient Characteristics
timeFrame: Index day (Date of hospitalization) to 24hours
measure: Sociodemographic Characteristics of eligible patients
timeFrame: Index day (Date of hospitalization) to 24hours
measure: Sociodemographic Characteristics
timeFrame: Index day (Date of hospitalization) to 24hours
measure: Clinical characteristics
timeFrame: Index day (Date of hospitalization) to 24hours
measure: Clinical Characteristics
timeFrame: Index day (Date of hospitalization) to 24hours
measure: FXa inhibitor characteristics
timeFrame: Time of last Fxa inhibitor dose to the time of hospital admission of maximum 24 hours
measure: ICH characteristics
timeFrame: Index day to 1 week
measure: GCS score
timeFrame: Index day to 24hours
measure: mRS score
timeFrame: Index day to 24 hours
measure: NIHSS score
timeFrame: Index date up to 24 hours
measure: Haematoma volume
timeFrame: Index day to 24 hours
measure: BP (Systolic and Diastolic)
timeFrame: Index day to 72 hours
measure: Antihypertensive treatment
timeFrame: Index day to 1 Week
measure: In-hospital mortality due to any cause
timeFrame: Index date up to the death event during hospital stay (maximum 1 week)
measure: Mortality at 30 days, post index event
timeFrame: Index date up to 30 days
measure: Mortality at 3 months post index event
timeFrame: Index date up to 3 months
measure: Mortality at 6 months post index event
timeFrame: Index date up to 6 months
measure: Type of discharge disposition
timeFrame: Hospital discharge to Maximum of 6 months
Secondary outcomes:
measure: Time from symptoms onset to hospital admission
timeFrame: Baseline (which is the date of hospitalization i.e. Index date) to a maximum of 24 hours
measure: Time from Hospital admission to time taken to do Imaging scan
timeFrame: Index day (Date of hospitalization) to Maximum of one hour
measure: Time from hospital admission to administration of any haemostatic therapy
timeFrame: Index day (Date of hospitalization) to Maximum of one hour
measure: Healthcare resource utilization during hospitalisation
timeFrame: Index day to maximum of 1 week
measure: Length of hospitalisation in days
timeFrame: Index day to maximum of 1 week
measure: Disability rate among survivors
timeFrame: At hospital discharge (Maximum of 1 week from Index day)
measure: Disability rate among survivors
timeFrame: Index day to 3 months
measure: Health care resource utilization after hospital admission up to 6 months
timeFrame: Index date to 6 months
measure: Health care resource utilization within 6 months after hospital discharge.
timeFrame: Hospital discharge up to 6 months
measure: Disability rate among survivors
timeFrame: Index day to Maximum of 6 months
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Research Site
city: Joinville
country: Brazil
facility: Research Site
city: Porto Alegre
country: Brazil
facility: Research Site
city: Bogota
country: Colombia
facility: Research Site
city: Ciudad de Mexico
country: Mexico
facility: Research Site
city: Doha
country: Qatar
facility: Research Site
city: Mekkah
country: Saudi Arabia
facility: Research Site
city: Riyadh
country: Saudi Arabia
facility: Research Site
city: Abu Dhabi
country: United Arab Emirates
facility: Research Site
city: Al Ain
country: United Arab Emirates
facility: Research Site
Study officials:
References: