## Protocol Section
### Identification Module
**NCT ID:** NCT06420011

**Acronym:** FAITH

**Brief Title:** 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)

#### Organization Study ID Info
**ID:** D9603R00022
#### Organization
**Class:** INDUSTRY
**Full Name:** AstraZeneca
### Status Module
#### Completion Date
**Date:** 2024-09-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-09-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-15

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-04
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** AstraZeneca

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- InTracranial Haemorrhage

**Keywords:**

- Factor XA Inhibitor-Related InTracranial Haemorrhage

- FXa

- ICH

- FAITH

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 350

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Patient characteristics

**Time Frame:** Index day (Date of hospitalization) to 24hours

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

**Measure:** Patient Characteristics

**Time Frame:** Index day (Date of hospitalization) to 24hours

**Description:** Sociodemographic characteristics like Sex (Male or Female) of the eligible patients is recorded on Index day

**Measure:** Sociodemographic Characteristics of eligible patients

**Time Frame:** Index day (Date of hospitalization) to 24hours

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

**Measure:** Sociodemographic Characteristics

**Time Frame:** Index day (Date of hospitalization) to 24hours

**Description:** Comorbidities info of the eligible patients is recorded on Index day

**Measure:** Clinical characteristics

**Time Frame:** Index day (Date of hospitalization) to 24hours

**Description:** Clinical characteristics like BMI in Kg/m2 of the eligible patients is recorded on Index day

**Measure:** Clinical Characteristics

**Time Frame:** Index day (Date of hospitalization) to 24hours

**Description:** At index date the following FXa inhibitor characteristics will be described :

Indication ,type and dose pf FXa Inhibitor

**Measure:** FXa inhibitor characteristics

**Time Frame:** Time of last Fxa inhibitor dose to the time of hospital admission of maximum 24 hours

**Description:** The primary ICH characteristics like type, site and presence of multicompartment haemorrhage during hospitalisation from Index date to 24hours

**Measure:** ICH characteristics

**Time Frame:** Index day to 1 week

**Description:** 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)

**Measure:** GCS score

**Time Frame:** Index day to 24hours

**Description:** 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

**Measure:** mRS score

**Time Frame:** Index day to 24 hours

**Description:** 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

**Measure:** NIHSS score

**Time Frame:** Index date up to 24 hours

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

**Measure:** Haematoma volume

**Time Frame:** Index day to 24 hours

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

**Measure:** BP (Systolic and Diastolic)

**Time Frame:** Index day to 72 hours

**Description:** Antihypertensive treatment patterns during hospitalisation from Index date to 1 week

**Measure:** Antihypertensive treatment

**Time Frame:** Index day to 1 Week

**Description:** Number of patients died between index date (date of hospitalization) to Hospital discharge (maximum of 1 week)

**Measure:** In-hospital mortality due to any cause

**Time Frame:** Index date up to the death event during hospital stay (maximum 1 week)

**Description:** Number of patients died between index date (date of hospitalization) up to 30 days

**Measure:** Mortality at 30 days, post index event

**Time Frame:** Index date up to 30 days

**Description:** Number of patients died between index date (date of hospitalization) up to 3 months

**Measure:** Mortality at 3 months post index event

**Time Frame:** Index date up to 3 months

**Description:** Number of patients died between index date (date of hospitalization) up to 6 months

**Measure:** Mortality at 6 months post index event

**Time Frame:** Index date up to 6 months

**Description:** 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

**Measure:** Type of discharge disposition

**Time Frame:** Hospital discharge to Maximum of 6 months

#### Secondary Outcomes

**Description:** Time between the onset of the bleeding symptoms to admission of patient in hospital in hours.

**Measure:** Time from symptoms onset to hospital admission

**Time Frame:** Baseline (which is the date of hospitalization i.e. Index date) to a maximum of 24 hours

**Description:** Time between patient hospital admission to the performing of Imaging scan in minutes, less than 1 hour

**Measure:** Time from Hospital admission to time taken to do Imaging scan

**Time Frame:** Index day (Date of hospitalization) to Maximum of one hour

**Description:** Time between patient hospital admission to start of the any haemostatic therapy in minutes, in less than 1 hour

**Measure:** Time from hospital admission to administration of any haemostatic therapy

**Time Frame:** Index day (Date of hospitalization) to Maximum of one hour

**Description:** The length of ICU stay of eligible patients in days from Index day to maximum of 1 week

**Measure:** Healthcare resource utilization during hospitalisation

**Time Frame:** Index day to maximum of 1 week

**Description:** The length of hospitalisation of eligible patients in days from Index day to maximum of 1 week

**Measure:** Length of hospitalisation in days

**Time Frame:** Index day to maximum of 1 week

**Description:** 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

**Measure:** Disability rate among survivors

**Time Frame:** At hospital discharge (Maximum of 1 week from Index day)

**Description:** At three months, after the index event (date of hospital admission) Modified Rankin Score (mRS) will be described.

**Measure:** Disability rate among survivors

**Time Frame:** Index day to 3 months

**Description:** 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.

**Measure:** Health care resource utilization after hospital admission up to 6 months

**Time Frame:** Index date to 6 months

**Description:** 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.

**Measure:** Health care resource utilization within 6 months after hospital discharge.

**Time Frame:** Hospital discharge up to 6 months

**Description:** At six months after the index event (date of hospital admission) Modified Rankin Score (mRS) will be described.

**Measure:** Disability rate among survivors

**Time Frame:** Index day to Maximum of 6 months

### Eligibility Module

**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.

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- 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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** information.center@astrazeneca.com

**Name:** AstraZeneca Clinical Study Information Center

**Phone:** 1-877-240-9479

**Role:** CONTACT

### IPD Sharing Statement Module

**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.

**Description:** 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.

**IPD Sharing:** YES

**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.

**URL:** https://astrazenecagroup-dt.pharmacm.com/DT/Home

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000002561

- Term: Cerebrovascular Disorders

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

### Condition Browse Module - Browse Leaves

- ID: M9556

- Name: Hemorrhage

- Relevance: HIGH

- As Found: Hemorrhage

- ID: M22113

- Name: Intracranial Hemorrhages

- Relevance: HIGH

- As Found: Intracranial Hemorrhage

- ID: M5810

- Name: Cerebrovascular Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000020300

- Term: Intracranial Hemorrhages

- ID: D000006470

- Term: Hemorrhage

### Intervention Browse Module - Browse Branches

- Abbrev: AnCoag

- Name: Anticoagulants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M30513

- Name: Factor Xa Inhibitors

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
