Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time from symptoms onset to hospital admission | Time between the onset of the bleeding symptoms to admission of patient in hospital in hours. | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Buenos Aires | Argentina | ||||
| Research Site |
Not provided
| Label | URL |
|---|---|
| Redacted CSR synopsis | View source |
Not provided
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.
Not provided
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.
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.
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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
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 |
Time between patient hospital admission to the performing of Imaging scan in minutes, less than 1 hour |
| 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 | 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 | 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 | 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 | 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. | 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. | 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. | 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. | Index day to Maximum of 6 months |
| Joinville |
| Brazil |
| Research Site | Porto Alegre | Brazil |
| Research Site | Bogotá | Colombia |
| Research Site | Mexico City | Mexico |
| Research Site | Doha | Qatar |
| Research Site | Mecca | Saudi Arabia |
| Research Site | Riyadh | Saudi Arabia |
| Research Site | Abu Dhabi | United Arab Emirates |
| Research Site | Al Ain City | United Arab Emirates |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |