Major BleedingREVERXaLNCT06147830
A Study to Describe the Characteristics, Health Care Interventions and Outcomes of Patients With Major Bleedings in the Presence of Factor Xa Inhibitor Treatment
An observational study of Major Bleeding, run by AstraZeneca at 75 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Major Bleeding
- What is being tested?
- None (Observational study)
- How many people
- 2,202 participants
- Where
- 75 sitesin 4 countries
- Study dates
- 4 Dec 2023to 30 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients aged ≥18 years admitted to hospital with an acute major bleeding or developed an acute bleeding while already in hospital and received ongoing treatment with a Factor Xa inhibitor before the index date.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
75 sites in 4 countries.
75 sites in 4 countries
United States25 sites
Research Site
Albany, New York, 12208
Research Site
Chandler, Arizona, 85224
Research Site
Chapel Hill, North Carolina, 27514
Research Site
Columbus, Ohio, 43210
Research Site
Dallas, Texas, 75390
Research Site
Glenview, Illinois, 60026
Research Site
Hartford, Connecticut, 06102
Research Site
Kansas City, Kansas, 66160
Research Site
Kansas City, Missouri, 64111
Research Site
Lakewood, Colorado, 80228-1527
Research Site
Lexington, Kentucky, 40536
Research Site
Milwaukee, Wisconsin, 53226
Research Site
New Hyde Park, New York, 11040
Research Site
Orange, California, 92868
Research Site
Orlando, Florida, 32803
Research Site
Portland, Oregon, 97201-3098
Research Site
Royal Oak, Michigan, 48073
Research Site
Sacramento, California, 95817
Research Site
St Louis, Missouri, 63110
Research Site
Staten Island, New York, 10305
Research Site
Stony Brook, New York, 11794
Research Site
Tampa, Florida, 33606
Research Site
Toledo, Ohio, 43614
Research Site
Torrance, California, 90509
Research Site
Valhalla, New York, 10595
Germany22 sites
Research Site
Aachen
Research Site
Altenburg
Research Site
Bad Neustadt/Saale
Research Site
Berlin
Research Site
Bochum
Research Site
Bonn
Research Site
Cologne
Research Site
Dortmund
Research Site
Dresden
Research Site
Essen
Research Site
G Ppingen
Research Site
Jena
Research Site
Koblenz
Research Site
L Beck
Research Site
L Neburg
Research Site
Leipzig
Research Site
Ludwigshafen am Rhein
Research Site
Osnabr Ck
Research Site
Potsdam
Research Site
Trier
Research Site
Tübingen
Research Site
Würzburg
Japan16 sites
Research Site
Asahikawa
Research Site
Fukuoka
Research Site
Hitachi
Research Site
Izumo
Research Site
Kagoshima
Research Site
Kamakura
Research Site
Kitakyushu
Research Site
Kyoto
Research Site
Mitaka
Research Site
Nagakute
Research Site
Okayama
Research Site
Saga
Research Site
Shimotsuke
Research Site
Suita
Research Site
Tachikawa
Research Site
Tokyo
United Kingdom12 sites
Research Site
Aberdeen
Research Site
Bournemouth
Research Site
Canterbury
Research Site
Cardiff
Research Site
Edgbaston
Research Site
Harrow
Research Site
Liverpool
Research Site
London
Research Site
Oxford
Research Site
Preston
Research Site
Sheffield
Research Site
Southampton
About this study
Official title: A Multinational Observational Longitudinal Study to Describe the Patient Characteristics, Health Care Interventions, and Health Outcomes of Patients With Major Bleedings in the Presence of Factor Xa Inhibitor Treatment
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.
Read the 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
- Being tested
- None (Observational study)
- Keywords
- real-world evidence, Factor Xa inhibitor treatment, reversal/replacement therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None (Observational study)Other
Also called Observational Study
Not Applicable since Observational Study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: None (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. Receives: Other: None (Observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographics (age in years)
Summary statistics will be used to describe demographics.
Measured: Cohort A: from admission for the bleeding (index date) until hospital discharge. Cohort B: from index date (time of administration of reversal/replacement agent) to hospital discharge (up to 90 days)
Demographics (sex)
Summary statistics will be used to describe demographics.
Measured: Cohort A: from admission for the bleeding (index date) until hospital discharge. Cohort B: from index date (time of administration of reversal/replacement agent) to hospital discharge (up to 90 days)
Demographics (ethnicity)
Summary statistics will be used to describe demographics.
Measured: Cohort A: from admission for the bleeding (index date) until hospital discharge. Cohort B: from index date (time of administration of reversal/replacement agent) to hospital discharge (up to 90 days)
Demographics (race)
Summary statistics will be used to describe demographics.
Measured: Cohort A: from admission for the bleeding (index date) until hospital discharge. Cohort B: from index date (time of administration of reversal/replacement agent) to hospital discharge (up to 90 days)
Demographics (payer type)
Summary statistics will be used to describe demographics.
Measured: Cohort A: from admission for the bleeding (index date) until hospital discharge. Cohort B: from index date (time of administration of reversal/replacement agent) to hospital discharge (up to 90 days)
Clinical presentation
Summary statistics will be used to describe clinical presentation of patients.
Measured: Cohort A: from admission for the bleeding (index date) until hospital discharge. Cohort B: from index date (time of administration of reversal/replacement agent) to hospital discharge (up to 90 days)
Healthcare interventions provided during acute care phase
To describe the health care interventions provided during acute care phase in patients with major bleedings in the context of Factor Xa inhibitor treatment.
Measured: Cohort A: from admission for the bleeding (index date) until hospital discharge. Cohort B: from index date (time of administration of reversal/replacement agent) to hospital discharge (up to 90 days)
In-hospital outcomes
To describe the in-hospital outcomes in patients with major bleedings in the context of Factor Xa inhibitor treatment.
Measured: Cohort A: from admission for the bleeding (index date) until hospital discharge. Cohort B: from index date (time of administration of reversal/replacement agent) to hospital discharge (up to 90 days)
Timing of administration of reversal/replacement agents since admission/bleed onset
To describe the timing of administration of reversal/replacement agents from admission/bleed onset.
Measured: Cohort A: from admission for the bleeding (index date) until hospital discharge. Cohort B: from index date (time of administration of reversal/replacement agent) to hospital discharge (up to 90 days)
Short Form Health Survey (SF-36) - Cohort B
The 36-Item Short Form Health Survey Version 2 (SF-36 v2) is a standardized, patient-administered instrument across eight domains (including physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health). Each subscale is scored separately, and the scores range from 0 to 100. Higher scores indicate better health-related quality of life.
Measured: Cohort B: from index date (time of administration of reversal/replacement agent) to hospital discharge (up to 90 days)
5-Dimension Health Questionnaire 5 Level (EQ-5D-5L) - Cohort B
The EuroQoL EQ-5D-5L questionnaire measures generic Health-Related Quality of Life (HRQoL) and contains questions on five dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety/depression. Each subscale is scored based on 5 levels of severity (no problems, slight problems, moderate problems, severe problems, and unable to perform or extreme problems). It can be converted into a single numeric score and has been translated and validated in numerous countries. The EQ-5D-5L scoring system assigns a utility value to each health state based on population preferences. The utility values range from -0.594 (representing the worst health state possible) to 1.000 (representing perfect health).
Measured: Cohort B: from index date (time of administration of reversal/replacement agent) to hospital discharge (up to 90 days)
Secondary outcomes (4)
Clinical outcomes - Cohort B
To describe the clinical outcomes in patients who experienced major bleedings in the context of Factor Xa inhibitor treatment and administered reversal/replacement therapy.
Measured: At 30 days post index (date of administration of reversal/replacement agents)
Timing of administration of reversal/replacement therapy since admission/bleed onset - Cohort B
To describe the timing of administration of reversal replacement therapy since admission/bleed onset.
Measured: At 30 days post index (date of administration of reversal/replacement agents)
Short Form Health Survey (SF-36) - Cohort B
The 36-Item Short Form Health Survey Version 2 (SF-36 v2) is a standardized, patient-administered instrument across eight domains (including physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. Each subscale is scored separately, and the scores range from 0 to 100. Higher scores indicate better health-related quality of life.
Measured: 30 days post index (date of administration of reversal/replacement agents)
5-Dimension Health Questionnaire 5 Level (EQ-5D-5L) - Cohort B
The EuroQoL EQ-5D-5L questionnaire measures generic HRQoL and contains questions on five dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety/depression. Each subscale is scored based on 5 levels of severity (no problems, slight problems, moderate problems, severe problems, and unable to perform or extreme problems). It can be converted into a single numeric score and has been translated and validated in numerous countries. The EQ-5D-5L scoring system assigns a utility value to each health state based on population preferences. The utility values range from -0.594 (representing the worst health state possible) to 1.000 (representing perfect health).
Measured: 30 days post index (date of administration of reversal/replacement agents)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start4 Dec 2023
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major BleedingStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2,202 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06147830
- Sponsor's protocol ID
- D9603R00003
- Acronym
- REVERXaL
- Status last verified
- Oct 2025
- First submitted
- 23 Oct 2023
- Last updated
- 3 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests 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 approved.
Publications
Alikhan R, Nour M, Tiede A, Ofori-Asenso R, Yasaka M, Chen H, Sehgal V, Yokobori S, Odelade O, Cash BD, Maegele M, Singer AJ. Patient characteristics, treatment patterns, and clinical outcomes in patients hospitalized with factor Xa inhibitor-associated major bleeds: A report from the REVERXaL study. Thromb Res. 2026 Apr;260:109650. doi: 10.1016/j.thromres.2026.109650. Epub 2026 Mar 10.
PubMed 41903429Alikhan 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.
PubMed 38905928
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multinational Observational Longitudinal Study to Describe the Patient Characteristics, Health Care Interventions, and Health Outcomes of Patients With Major Bleedings in the Presence of Factor Xa Inhibitor Treatment
- ClinicalTrials.gov ID
- NCT06147830
- Acronym / sponsor ID
- REVERXaL / D9603R00003
- Conditions
- Major Bleeding
- Keywords
- real-world evidence, Factor Xa inhibitor treatment, reversal/replacement therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,202 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 28 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A - Historical Cohort | – | Other: None (Observational study)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. |
| Cohort B - Prospective Cohort | – | Other: None (Observational study)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. |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients aged ≥18 years admitted to hospital with an acute major bleeding or developed an acute bleeding while already in hospital and received ongoing treatment with a Factor Xa inhibitor before the index date.
Key inclusion criteria (6 listed)
- 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
- Administered reversal or replacement therapy
Key exclusion criteria (6 listed)
- Pregnant women
- Patients enrolled in any interventional trial that includes reversal/replacement agents
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None (Observational study)Also: Observational StudyNot Applicable since Observational Study | Other | Cohort A - Historical Cohort, Cohort B - Prospective Cohort |
Primary outcome
Demographics (age in years)
Time frame: Cohort A: from admission for the bleeding (index date) until hospital discharge. Cohort B: from index date (time of administration of reversal/replacement agent) to hospital discharge (up to 90 days)
Summary statistics will be used to describe demographics.
Demographics (sex)
Time frame: Cohort A: from admission for the bleeding (index date) until hospital discharge. Cohort B: from index date (time of administration of reversal/replacement agent) to hospital discharge (up to 90 days)
Summary statistics will be used to describe demographics.
Demographics (ethnicity)
Time frame: Cohort A: from admission for the bleeding (index date) until hospital discharge. Cohort B: from index date (time of administration of reversal/replacement agent) to hospital discharge (up to 90 days)
Summary statistics will be used to describe demographics.
Demographics (race)
Time frame: Cohort A: from admission for the bleeding (index date) until hospital discharge. Cohort B: from index date (time of administration of reversal/replacement agent) to hospital discharge (up to 90 days)
Summary statistics will be used to describe demographics.
Demographics (payer type)
Time frame: Cohort A: from admission for the bleeding (index date) until hospital discharge. Cohort B: from index date (time of administration of reversal/replacement agent) to hospital discharge (up to 90 days)
Summary statistics will be used to describe demographics.
Clinical presentation
Time frame: Cohort A: from admission for the bleeding (index date) until hospital discharge. Cohort B: from index date (time of administration of reversal/replacement agent) to hospital discharge (up to 90 days)
Summary statistics will be used to describe clinical presentation of patients.
Healthcare interventions provided during acute care phase
Time frame: Cohort A: from admission for the bleeding (index date) until hospital discharge. Cohort B: from index date (time of administration of reversal/replacement agent) to hospital discharge (up to 90 days)
To describe the health care interventions provided during acute care phase in patients with major bleedings in the context of Factor Xa inhibitor treatment.
In-hospital outcomes
Time frame: Cohort A: from admission for the bleeding (index date) until hospital discharge. Cohort B: from index date (time of administration of reversal/replacement agent) to hospital discharge (up to 90 days)
To describe the in-hospital outcomes in patients with major bleedings in the context of Factor Xa inhibitor treatment.
Timing of administration of reversal/replacement agents since admission/bleed onset
Time frame: Cohort A: from admission for the bleeding (index date) until hospital discharge. Cohort B: from index date (time of administration of reversal/replacement agent) to hospital discharge (up to 90 days)
To describe the timing of administration of reversal/replacement agents from admission/bleed onset.
Short Form Health Survey (SF-36) - Cohort B
Time frame: Cohort B: from index date (time of administration of reversal/replacement agent) to hospital discharge (up to 90 days)
The 36-Item Short Form Health Survey Version 2 (SF-36 v2) is a standardized, patient-administered instrument across eight domains (including physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health). Each subscale is scored separately, and the scores range from 0 to 100. Higher scores indicate better health-related quality of life.
5-Dimension Health Questionnaire 5 Level (EQ-5D-5L) - Cohort B
Time frame: Cohort B: from index date (time of administration of reversal/replacement agent) to hospital discharge (up to 90 days)
The EuroQoL EQ-5D-5L questionnaire measures generic Health-Related Quality of Life (HRQoL) and contains questions on five dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety/depression. Each subscale is scored based on 5 levels of severity (no problems, slight problems, moderate problems, severe problems, and unable to perform or extreme problems). It can be converted into a single numeric score and has been translated and validated in numerous countries. The EQ-5D-5L scoring system assigns a utility value to each health state based on population preferences. The utility values range from -0.594 (representing the worst health state possible) to 1.000 (representing perfect health).
4 secondary outcomes
Clinical outcomes - Cohort B
Time frame: At 30 days post index (date of administration of reversal/replacement agents)
Timing of administration of reversal/replacement therapy since admission/bleed onset - Cohort B
Time frame: At 30 days post index (date of administration of reversal/replacement agents)
Short Form Health Survey (SF-36) - Cohort B
Time frame: 30 days post index (date of administration of reversal/replacement agents)
5-Dimension Health Questionnaire 5 Level (EQ-5D-5L) - Cohort B
Time frame: 30 days post index (date of administration of reversal/replacement agents)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2025.
- Derived from this study: PubMed 41903429Alikhan R, Nour M, Tiede A, Ofori-Asenso R, Yasaka M, Chen H, Sehgal V, Yokobori S, Odelade O, Cash BD, Maegele M, Singer AJ. Patient characteristics, treatment patterns, and clinical outcomes in patients hospitalized with factor Xa inhibitor-associated major bleeds: A report from the REVERXaL study. Thromb Res. 2026 Apr;260:109650. doi: 10.1016/j.thromres.2026.109650. Epub 2026 Mar 10.
- Derived from this study: PubMed 38905928Alikhan 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.
- Redacted CSR synopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests 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 approved.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
75 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Bleeding, run by AstraZeneca at 75 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 75 sites in United States, Germany, Japan, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographics (age in years) (time frame: Cohort A: from admission for the bleeding (index date) until hospital discharge. Cohort B: from index date (time of administration of reversal/replacement agent) to hospital discharge (up to 90 days)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06147830, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2025.