InTracranial HaemorrhageFAITHNCT06420011
FAITH - Factor XA Inhibitor-Related InTracranial Haemorrhage
An observational study of InTracranial Haemorrhage, run by AstraZeneca at 10 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- InTracranial Haemorrhage
- How many people
- 123 participants
- Where
- 10 sitesin 7 countries
- Study dates
- 8 Jul 2024to 1 Nov 2024
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients who were treated with andexanet alfa.
- Patients who were enrolled in any clinical trials during the study period.
Trial locations and contacts
10 sites in 7 countries.
10 sites in 7 countries
United Arab Emirates2 sites
Research Site
Abu Dhabi
Research Site
Al Ain City
About this study
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)
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.
Read the 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.
- Conditions
- InTracranial Haemorrhage
- Keywords
- Factor XA Inhibitor-Related InTracranial Haemorrhage, FXa, ICH, FAITH
- Medical subject headings
- Intracranial Hemorrhages
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient characteristics
Age of the patients at the time of hospital admission (years) is recorded on Index day within 24 hours of hospitalization
Measured: Index day (Date of hospitalization) to 24hours
Patient Characteristics
Race (Middle Eastern, Asian, other) of the eligible patients is collected
Measured: Index day (Date of hospitalization) to 24hours
Sociodemographic Characteristics of eligible patients
Sociodemographic characteristics like Sex (Male or Female) of the eligible patients is recorded on Index day
Measured: Index day (Date of hospitalization) to 24hours
Sociodemographic Characteristics
Sociodemographic characteristics like nationality of the eligible patients info is collected on Index day
Measured: Index day (Date of hospitalization) to 24hours
Clinical characteristics
Comorbidities info of the eligible patients is recorded on Index day
Measured: Index day (Date of hospitalization) to 24hours
Clinical Characteristics
Clinical characteristics like BMI in Kg/m2 of the eligible patients is recorded on Index day
Measured: Index day (Date of hospitalization) to 24hours
FXa inhibitor characteristics
At index date the following FXa inhibitor characteristics will be described :
Indication ,type and dose pf FXa Inhibitor
Measured: Time of last Fxa inhibitor dose to the time of hospital admission of maximum 24 hours
ICH characteristics
The primary ICH characteristics like type, site and presence of multicompartment haemorrhage during hospitalisation from Index date to 24hours
Measured: Index day to 1 week
GCS score
The GCS is scored between 3 and 15. 3 being the worst and 15 the best. It is composed of three parameters: best eye response (E), best verbal response (V), and best motor response (M)
Measured: Index day to 24hours
mRS score
mRS score recorded within 24 hours on Index date The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or others causes of neurological disability. It is scored from: 0=No symptoms at all
- No significant disability
- Slight disability
- Moderate disability
- Moderately severe disability 5=Severe disability
6=death
Measured: Index day to 24 hours
NIHSS score
NIHSS score recorded within 24 hours on the Index date
Scores range from 0 to 42, with higher scores indicating greater severity. Stroke severity may be stratified on the basis of NIHSS scores as follows:
Very Severe: >25 Severe: 15 - 24 Mild to Moderately Severe: 5 - 14 Mild: 1 - 5
Measured: Index date up to 24 hours
Haematoma volume
Haematoma volume based on baseline Imaging scans taken within 24 hours on the index date
Measured: Index day to 24 hours
BP (Systolic and Diastolic)
BP at Index date during hospital admission and in 6, 24, and 72 hours
Measured: Index day to 72 hours
Antihypertensive treatment
Antihypertensive treatment patterns during hospitalisation from Index date to 1 week
Measured: Index day to 1 Week
In-hospital mortality due to any cause
Number of patients died between index date (date of hospitalization) to Hospital discharge (maximum of 1 week)
Measured: Index date up to the death event during hospital stay (maximum 1 week)
Mortality at 30 days, post index event
Number of patients died between index date (date of hospitalization) up to 30 days
Measured: Index date up to 30 days
Mortality at 3 months post index event
Number of patients died between index date (date of hospitalization) up to 3 months
Measured: Index date up to 3 months
Mortality at 6 months post index event
Number of patients died between index date (date of hospitalization) up to 6 months
Measured: Index date up to 6 months
Type of discharge disposition
During the period from the hospital discharge date up to death event or 6 months, whichever occurs first, the following type of hospital discharge disposition will be described for survivors like Home, inpatient rehabilitation facility, nursing home, other hospitals/medical centres
Measured: Hospital discharge to Maximum of 6 months
Secondary outcomes (10)
Time from symptoms onset to hospital admission
Time between the onset of the bleeding symptoms to admission of patient in hospital in hours.
Measured: Baseline (which is the date of hospitalization i.e. Index date) to a maximum of 24 hours
Time from Hospital admission to time taken to do Imaging scan
Time between patient hospital admission to the performing of Imaging scan in minutes, less than 1 hour
Measured: Index day (Date of hospitalization) to Maximum of one hour
Time from hospital admission to administration of any haemostatic therapy
Time between patient hospital admission to start of the any haemostatic therapy in minutes, in less than 1 hour
Measured: Index day (Date of hospitalization) to Maximum of one hour
Healthcare resource utilization during hospitalisation
The length of ICU stay of eligible patients in days from Index day to maximum of 1 week
Measured: Index day to maximum of 1 week
Length of hospitalisation in days
The length of hospitalisation of eligible patients in days from Index day to maximum of 1 week
Measured: Index day to maximum of 1 week
Disability rate among survivors
At hospital discharge (Maximum of 1 week from Index day) Modified Rankin Score (mRS) will be described
Functional outcome assessed with the modified Rankin Scale (mRS) at hospital discharge .The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered of stroke or other causes of neurological disability. It is scored from:
0=No symptoms at all
1=No significant disability, 2=Slight disability 3=Moderate disability 4=Moderately severe disability 5=Severe disability 6=death
Measured: At hospital discharge (Maximum of 1 week from Index day)
Disability rate among survivors
At three months, after the index event (date of hospital admission) Modified Rankin Score (mRS) will be described.
Measured: Index day to 3 months
Health care resource utilization after hospital admission up to 6 months
From the index date to 6 months the following HCRU will be described:
Need for supportive medical care ,type of supportive care (including rehabilitation services), inpatient rehabilitation, outpatient rehabilitation, including occupational therapists, speech and language pathologists, dietician, nurse, adaptive equipment, everything else.
Measured: Index date to 6 months
Health care resource utilization within 6 months after hospital discharge.
From the patient hospital discharge up to 6 months the following HCRU will be described:
Number of inpatient readmissions after discharge and up to 6 months, Type of ward, Number of days of hospitalization Reason for readmission and Medications.
Measured: Hospital discharge up to 6 months
Disability rate among survivors
At six months after the index event (date of hospital admission) Modified Rankin Score (mRS) will be described.
Measured: Index day to Maximum of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start8 Jul 2024
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InTracranial HaemorrhageStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420011
- Sponsor's protocol ID
- D9603R00022
- Acronym
- FAITH
- Status last verified
- Aug 2025
- First submitted
- 4 Mar 2024
- Last updated
- 27 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.