Observational analysis of hospitalized patients treated with andexanet alfa
Retrospective Real World Evidence Study to Describe Characteristics and Outcomes in Dutch Patients Admitted to the Hospital With a Factor Xa Inhibitor-associated Bleeding Treated With Andexanet Alfa
This study looks at hospitalized patients who received andexanet alfa to see how well it works and what happens to them afterward, especially regarding blood clots.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT05898412 on ClinicalTrials.gov |
What this trial studies
This observational retrospective study analyzes data from hospitalized patients in approximately 10 Dutch hospitals who were treated with andexanet alfa, a reversal agent for factor Xa inhibitors. The study aims to characterize patient profiles and outcomes, particularly focusing on the incidence of thrombotic events following treatment. By examining real-world data, the research seeks to provide insights into the effectiveness and safety of andexanet alfa compared to other treatment options like prothrombin complex concentrate. The findings will help inform clinicians about the appropriate use of andexanet alfa in managing major bleeding events.
Who should consider this trial
Good fit: Ideal candidates for this study are hospitalized patients aged 18 years and older who have received at least one dose of andexanet alfa.
Not a fit: Patients who have not been treated with andexanet alfa or are under 18 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of andexanet alfa's effectiveness, leading to improved treatment protocols for patients experiencing major bleeding.
How similar studies have performed: Previous studies have shown that andexanet alfa may be more effective than alternative treatments, but this specific observational approach is novel in the Dutch context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Received at least one dose of andexanet alfa Exclusion Criteria: None
Where this trial is running
Amsterdam
- Research Site — Amsterdam, Netherlands (Recruiting)
Study contacts
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.