A Study to Describe the Characteristics, Health Care Interventions and Outcomes of Patients With Major Bleedings in the Presence of Factor Xa Inhibitor Treatment

NCT ID: NCT06147830

Last Updated: 2025-11-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2202 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-04
• Study Completion Date: 2024-11-30

Brief Summary

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.

Detailed Description

REVERXaL is a multinational observational study incorporating 2 patient cohorts (historical and prospective) with major bleeds during Factor Xa inhibitor use. This study will be mainly descriptive in nature without any pre-specified statistical hypotheses. Variables will be collected according to routine medical practice either through primary data collection directly from patients, or from secondary data collection via data extraction from electronic or paper medical records into electronic case report forms (eCRFs). Patients will undergo clinical assessments and receive standard medical care as determined by their treating physicians. Patients will not receive any experimental disease management intervention or experimental treatment because of their participation in the study. As part of routine care, study investigators will evaluate patients about their medical history, medication history, bleeding presentation, and any adverse event (AE) or severe adverse event (SAE) experiences since the previous clinical visit and the related information. No additional or pre-defined site visits will be scheduled outside of the patient's routine clinical visits.

Conditions

Major Bleeding

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Cohort A - Historical Cohort

Cohort A will comprise of approximately 2000 patients admitted for major bleedings in the presence of Factor Xa inhibitor treatment during a defined period (up to 2 years prior to commencing enrolment of patients in Cohort B). Patients who developed major bleeding in the presence of Factor Xa inhibitor treatment while already admitted in hospitals will also be included. Patients may or may not have received a reversal/replacement therapy. Patients are followed in medical charts from admission to discharge.

None (Observational study)

Intervention Type: OTHER

Not Applicable since Observational Study

Cohort B - Prospective Cohort

Cohort B will enrol approximately 2000 patients who were administered any reversal or replacement agent during the acute care phase for a major bleeding in the presence of Factor Xa inhibitor treatment at the participating sites. Patients will be followed up to three months after administration of reversal or replacement therapy.

None (Observational study)

Intervention Type: OTHER

Not Applicable since Observational Study

Interventions

None (Observational study)

Not Applicable since Observational Study

Intervention Type: OTHER

Other Intervention Names

Observational Study

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 130 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Parexel

INDUSTRY

Sponsor Role: collaborator

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site

Chandler, Arizona, United States

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Orange, California, United States

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Sacramento, California, United States

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Torrance, California, United States

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Lakewood, Colorado, United States

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Hartford, Connecticut, United States

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Orlando, Florida, United States

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Tampa, Florida, United States

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Glenview, Illinois, United States

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Kansas City, Kansas, United States

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Lexington, Kentucky, United States

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Royal Oak, Michigan, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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Albany, New York, United States

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New Hyde Park, New York, United States

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Staten Island, New York, United States

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Stony Brook, New York, United States

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Valhalla, New York, United States

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Chapel Hill, North Carolina, United States

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Columbus, Ohio, United States

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Toledo, Ohio, United States

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Portland, Oregon, United States

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Dallas, Texas, United States

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Milwaukee, Wisconsin, United States

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Aachen, , Germany

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Altenburg, , Germany

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Bad Neustadt/Saale, , Germany

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Berlin, , Germany

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Bochum, , Germany

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Bonn, , Germany

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Cologne, , Germany

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Dortmund, , Germany

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Dresden, , Germany

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Essen, , Germany

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G Ppingen, , Germany

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Jena, , Germany

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Koblenz, , Germany

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L Beck, , Germany

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L Neburg, , Germany

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Leipzig, , Germany

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Ludwigshafen am Rhein, , Germany

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Osnabr Ck, , Germany

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Potsdam, , Germany

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Trier, , Germany

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Tübingen, , Germany

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Würzburg, , Germany

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Asahikawa, , Japan

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Fukuoka, , Japan

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Hitachi, , Japan

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Izumo, , Japan

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Kagoshima, , Japan

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Kamakura, , Japan

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Kitakyushu, , Japan

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Kyoto, , Japan

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Mitaka, , Japan

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Nagakute, , Japan

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Okayama, , Japan

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Saga, , Japan

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Shimotsuke, , Japan

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Suita, , Japan

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Tachikawa, , Japan

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Tokyo, , Japan

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Aberdeen, , United Kingdom

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Bournemouth, , United Kingdom

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Canterbury, , United Kingdom

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Cardiff, , United Kingdom

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Edgbaston, , United Kingdom

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Harrow, , United Kingdom

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Liverpool, , United Kingdom

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London, , United Kingdom

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Oxford, , United Kingdom

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Preston, , United Kingdom

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Sheffield, , United Kingdom

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Southampton, , United Kingdom

Countries

United States; Germany; Japan; United Kingdom

References

Alikhan R, Nour M, Yasaka M, Ofori-Asenso R, Axelsson-Cheramy S, Chen H, Seghal V, Yokobori S, Koch B, Tiede A, Cash BD, Maegele M, Singer AJ. Design and rationale for REVERXaL: A real-world study of patients with factor Xa inhibitor-associated major bleeds. Thromb Res. 2024 Aug;240:109046. doi: 10.1016/j.thromres.2024.109046. Epub 2024 Jun 5.

Reference Type: DERIVED

PMID: 38905928 (View on PubMed)

Related Links

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D9603R00003&attachmentIdentifier=aaf79989-4c6c-4fed-bf4f-1394c039598c&fileName=d9603r00003_Redacted_CSR_synopsis.pdf&versionIdentifier=

Redacted CSR synopsis

Other Identifiers

D9603R00003

Identifier Type: -

Identifier Source: org_study_id