A Study to Describe the Characteristics, Health Care Interventions and Outcomes of Patients With Major Bleedings in the Presence of Factor Xa Inhibitor Treatment
Completed
Conditions studied: Major Bleeding
In brief
REVERXaL study aims to increase the understanding of the patient characteristics, bleeding presentation, health care interventions provided, and the clinical as well as self-reported health outcomes of patients with major bleeding in the presence of Factor Xa inhibitor treatment. The generation of insight on treatment approaches and associated outcomes in hospitalized patients with Factor Xa inhibitor-related major bleeds may inform clinical guidelines, health system decision making and streamline treatment pathways in this population.
Key facts
- Study ID
- NCT06147830
- Run by
- AstraZeneca
- People needed
- 2202
- Starts
- 2023-12-04
- Expected to finish
- 2024-11-30
- Last updated by the study team
- 2025-11-03
Who can join
Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Aged ≥18 years on the index date
- Admitted to the hospital with an acute major bleeding or developed an acute bleeding while already in hospital
- Ongoing treatment with a Factor Xa inhibitor before the index date
- Provided signed and dated informed consent or able to obtain a waiver
- In addition, for cohort B:
- Administered reversal or replacement therapy
You may not qualify if…
- Pregnant women
- Patients enrolled in any interventional trial that includes reversal/replacement agents
- In addition, for cohort B:
- Use of vitamin K antagonists, dabigatran, prothrombin complex concentrates or recombinant factor VII, or transfusion of whole blood or plasma within the preceding 7 days of the index event
- As judged by the investigator, if it is deemed undesirable for the patient to participate in the study or participant is unlikely to comply with study procedures, and requirements
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
Where it is running
- Research Site — Mitaka, Japan
- Research Site — Nagakute, Japan
- Research Site — Okayama, Japan
- Research Site — Saga, Japan
- Research Site — Shimotsuke, Japan
- Research Site — Suita, Japan
- Research Site — Tachikawa, Japan
- Research Site — Tokyo, Japan
- Research Site — Aberdeen, United Kingdom
- Research Site — Bournemouth, United Kingdom
- Research Site — Canterbury, United Kingdom
- Research Site — Cardiff, United Kingdom
- Research Site — Edgbaston, United Kingdom
- Research Site — Harrow, United Kingdom
- Research Site — Liverpool, United Kingdom
- Research Site — London, United Kingdom
- Research Site — Oxford, United Kingdom
- Research Site — Preston, United Kingdom
- Research Site — Sheffield, United Kingdom
- Research Site — Southampton, United Kingdom
- Research Site — Kitakyushu, Japan
- Research Site — Chandler, Arizona, United States
- Research Site — Orange, California, United States
- Research Site — Sacramento, California, United States
- Research Site — Kyoto, Japan
Full record on ClinicalTrials.gov
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