NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

FAITH - Factor XA Inhibitor-Related InTracranial Haemorrhage

NCT06420011

CompletedN/A

Sponsor: AstraZeneca

Conditions: InTracranial Haemorrhage

Countries: Argentina, Brazil, Colombia, Mexico, Qatar, Saudi Arabia, United Arab Emirates

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

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.

Locations (10)

Buenos Aires, Argentina
Joinville, Brazil
Porto Alegre, Brazil
Bogotá, Colombia
Mexico City, Mexico
Doha, Qatar
Mecca, Saudi Arabia
Riyadh, Saudi Arabia
Abu Dhabi, United Arab Emirates
Al Ain City, United Arab Emirates