FAITH - Factor XA Inhibitor-Related InTracranial Haemorrhage

NCT06420011 | Completed

• 1 other identifier: D9603R00022
• Study Type: observational
• Target: 123
• Locations: 7 countries
• Sites: 10

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.

Conditions

InTracranial Haemorrhage

Keywords

Factor XA Inhibitor-Related InTracranial Haemorrhage; FXa; ICH; FAITH

Outcome Measures

Primary Outcomes (19)

• Patient characteristics

  Age of the patients at the time of hospital admission (years) is recorded on Index day within 24 hours of hospitalization

  Index day (Date of hospitalization) to 24hours

• Patient Characteristics

  Race (Middle Eastern, Asian, other) of the eligible patients is collected

  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

  Index day (Date of hospitalization) to 24hours

• Sociodemographic Characteristics

  Sociodemographic characteristics like nationality of the eligible patients info is collected on Index day

  Index day (Date of hospitalization) to 24hours

• Clinical characteristics

  Comorbidities info of the eligible patients is recorded on Index day

  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

  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

  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

  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)

  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 1. No significant disability 2. Slight disability 3. Moderate disability 4. Moderately severe disability 5=Severe disability 6=death

  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

  Index date up to 24 hours

• Haematoma volume

  Haematoma volume based on baseline Imaging scans taken within 24 hours on the index date

  Index day to 24 hours

• BP (Systolic and Diastolic)

  BP at Index date during hospital admission and in 6, 24, and 72 hours

  Index day to 72 hours

• Antihypertensive treatment

  Antihypertensive treatment patterns during hospitalisation from Index date to 1 week

  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)

  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

  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

  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

  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

  Hospital discharge to Maximum of 6 months

Secondary Outcomes (10)

• Time from symptoms onset to hospital admission

  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

  Index day (Date of hospitalization) to Maximum of one hour

• Time from hospital admission to administration of any haemostatic therapy

  Index day (Date of hospitalization) to Maximum of one hour

• Healthcare resource utilization during hospitalisation

  Index day to maximum of 1 week

• Length of hospitalisation in days

  Index day to maximum of 1 week

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (10)

Research Site

Buenos Aires, Argentina

Location

Research Site

Joinville, Brazil

Location

Research Site

Porto Alegre, Brazil

Location

Research Site

Bogotá, Colombia

Location

Research Site

Mexico City, Mexico

Location

Research Site

Doha, Qatar

Location

Research Site

Mecca, Saudi Arabia

Location

Research Site

Riyadh, Saudi Arabia

Location

Research Site

Abu Dhabi, United Arab Emirates

Location

Research Site

Al Ain City, United Arab Emirates

Location

Related Links

• Redacted CSR synopsis

MeSH Terms

Conditions

Intracranial Hemorrhages

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: May 17, 2024
• Study Start: July 8, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: October 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

ME (1); AR (1); BR (2); CO (1); QA (1); SA (2); AE (2)