Study on Andexanet Alfa for Patients on Factor Xa Inhibitors (Apixaban, Rivaroxaban, Edoxaban) Needing Urgent Surgery to Reduce Bleeding Risk

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What is this study about?

This clinical trial is focused on patients who are taking medications known as Factor Xa inhibitors, which include apixaban, rivaroxaban, and edoxaban. These medications are used to prevent blood clots but can increase the risk of bleeding. The study is investigating the use of a treatment called andexanet alfa to help control bleeding in patients who need urgent surgery or a medical procedure. The purpose of the study is to determine if andexanet alfa is effective in managing bleeding during surgery compared to the usual care provided.

Participants in the study will be randomly assigned to receive either andexanet alfa or the standard treatment, which may include a placebo. The study will monitor the effectiveness of andexanet alfa in controlling bleeding during surgery and will also track changes in the activity of the Factor Xa inhibitors from the start of the surgery to two hours afterward. The study aims to provide valuable information on how well andexanet alfa works in real-world surgical settings.

The trial will involve a series of steps, including the administration of the treatment and careful monitoring of the patient’s condition during and after the surgery. The study is expected to continue until November 2026, with recruitment starting in December 2023. This research is important for improving the safety and effectiveness of surgeries for patients who are on Factor Xa inhibitors and need urgent medical attention.

1 joining the study

Upon joining the study, you will be required to provide informed consent. This means you agree to participate after understanding the details and potential risks of the study.

You will need to confirm that you require urgent surgery or a procedure and that you have been taking a medication known as a factor Xa inhibitor (such as apixaban, rivaroxaban, or edoxaban) within the last 15 hours.

2 screening

A screening process will be conducted to ensure you meet the study’s criteria. This includes confirming the need for urgent surgery or procedure and the use of a factor Xa inhibitor.

Female participants of childbearing potential will undergo a pregnancy test to ensure eligibility.

3 treatment administration

If eligible, you will receive a treatment called andexanet alfa or usual care. Andexanet alfa is administered through an intravenous infusion, which means it is given directly into a vein.

The goal of the treatment is to help control bleeding during your surgery or procedure.

4 surgery or procedure

You will undergo the planned urgent surgery or procedure. The medical team will monitor your condition closely to ensure effective control of bleeding.

5 post-surgery monitoring

After the surgery or procedure, your recovery will be monitored. This includes checking the effectiveness of the treatment in controlling bleeding.

Your anti-FXa activity levels, which indicate the effect of the factor Xa inhibitor, will be measured at the start of the surgery and two hours after the surgery begins.

6 follow-up

You will have follow-up visits to assess your recovery and any potential side effects from the treatment.

These visits are important to ensure your safety and the effectiveness of the treatment you received.

Who Can Join the Study?

  • The patient needs urgent surgery or a procedure, as decided by the doctor, and needs to stop the effect of a medicine called a direct oral FXa inhibitor (like apixaban, rivaroxaban, or edoxaban).
  • The patient must have the urgent surgery or procedure within 12 hours after agreeing to join the study.
  • The surgery or procedure is expected to have a high risk of bleeding or bleeding into an important organ.
  • The patient has taken an oral FXa inhibitor (such as apixaban, rivaroxaban, or edoxaban) within 15 hours or more before the start of the surgery or procedure.
  • Female patients who can have children must have a negative pregnancy test before starting the study.
  • Patients who can have children (both male and female) must agree to use very effective birth control methods.

Who Cannot Join the Study?

  • Patients who are not taking a FXa inhibitor medication like apixaban, rivaroxaban, or edoxaban.
  • Patients who do not need urgent surgery or a medical procedure.
  • Patients who do not have a major risk of bleeding.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specified clinical trial group.
  • Patients who are not male or female, as both genders are included in the study.
  • Patients who are not considered part of a vulnerable population.

Where you can join this trial?

Verified and Recommended Sites

Site Name City Country Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie Lublin Poland

Verified Sites

Other Sites

Site Name City Country Status
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz Szekesfehervar Hungary
Azienda Ospedaliera di Padova Padua Italy
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
General University Hospital Of Larissa Larissa Greece
Vilniaus universiteto ligonine Santaros klinikos VšĮ Vilnius Lithuania
Fakultni Nemocnice Brno Brno Czechia
Narodny Onkologicky Ustav Bratislava Slovakia
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Zala Megyei Szent Rafael Korhaz Zalaegerszeg Hungary
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo Milan Italy
MBAL Dr. Ivan Seliminski – Sliven AD Sliven Bulgaria
Centre Hospitalier De Cholet Cholet France
University Medical Center Ljubljana Ljubljana Slovenia
Multidisciplinary Hospital For Active Treatment Haskovo AD Haskovo Bulgaria
University Multiprofile Hospital For Active Treatment Eurohospital Plovdiv Ltd. Plovdiv Bulgaria
Multiprofile Hospital For Active Treatment Sveti Nikolay Chuditvorets EOOD Lom Bulgaria
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov Sofia Bulgaria
Mater Misericordiae University Hospital Dublin Ireland
University Of Debrecen Debrecen Hungary
Institutul Clinic Fundeni Bucharest Romania
Hospital Clinico Universitario De Valencia Valencia Spain
Mbal Lyulin EAD Sofia Bulgaria
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Sofia Bulgaria
Hospital Arnau De Vilanova De Valencia Valencia Spain
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara Romania
Lietuvos sveikatos mokslu universiteto Kauno ligonine Kaunas Lithuania
Hospital Universitario Virgen Macarena Sevilla Spain
Virgen del Rocío University Hospital Sevilla Spain
Universita’ Campus Bio-medico Di Roma Rome Italy
Tartu University Hospital Tartu Estonia
Centre Hospitalier Universitaire De Nantes Nantes France
Semmelweis University Budapest Hungary
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Centre Hospitalier Universitaire De Nimes Nimes France
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
Universitair Ziekenhuis Gent Gent Belgium
Universitaetsklinikum Aachen AöR Aachen Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos Kaunas Lithuania
Hospital Universitario Del Vinalopo Elche Spain
Algemeen Ziekenhuis Groeninge Kortrijk Belgium
Unidade Local De Saude De Amadora Sintra E.P.E. Amadora Portugal
Hospital Universitario Infanta Leonor Madrid Spain
Louna-Eesti Haigla AS Voru Estonia
Sihtasutus Ida-Viru Keskhaigla Kohtla-Jarve Linn Estonia
Ippokratio General Hospital Of Thessaloniki Thessaloniki Greece
Azienda Socio Sanitaria Territoriale Dei Sette Laghi Varese Italy
BG Unfallklinik Murnau gGmbH Murnau A. Staffelsee Germany
Unidade Local De Saude Do Alto Ave E.P.E. Guimaraes Portugal
BG Klinikum Bergmannstrost Halle gGmbH Halle (Saale) Germany
Uniwersytecki Szpital Kliniczny Nr 2 Uniwersytetu Medycznego W Lodzi SPZOZ Lodz Poland
Institutul De Urgenta Pentru Boli Cardiovasculare Prof. Dr. C. C. Iliescu Bucharest Romania
Henry Dunant Hospital Center Athens Greece
Mnogoprofilna Bolnitsa Za Aktivno Lechenie Hristo Botev AD Vratsa Bulgaria
Splosna Bolnisnica Celje Celje Slovenia
Marienhaus Klinikum Mainz GmbH Mainz Germany
Hospital Costa del Sol Marbella Spain
Anjbhnk Ookmxumiyom Njigbwsxb Sg Abrnqpt E Bfdctd E C Aynraa Aaipuvmorqq Alexandria Italy
Mwiaae Haykgykm Hypvv Ugoaetcbijfrppbexluq dwl Rwgtecrzrdinfgpz Bcevfg Herne Germany
Cdskwa Hakemvxhgc Uzntngavfffoy Da Prips Eqgvri Porto Portugal
Sz Vitoecvqplrrunr Uffejtraac Htlxfyhp Dublin Ireland
Amxtufu Obdaafqbysc Pdlk Gyqxzufy Xxzhg Bergamo Italy
Kkytvso zitddwxef axrt &xkwuel Mrrbrnlsug nngukuyds Úbhw nfv Lfqgft ouyp Usti Nad Labem Czechia
Uhbacgfftv Govnwsc Hldwtdyu Aisifzj Athens Greece
Uecpzxwatu Hkvpsdia Qlyzm Guwcnqa Sofia Bulgaria

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
22.12.2023
Belgium Belgium
Not recruiting
22.12.2023
Bulgaria Bulgaria
Not recruiting
22.12.2023
Czechia Czechia
Not recruiting
22.12.2023
Denmark Denmark
Not recruiting
22.12.2023
Estonia Estonia
Not recruiting
22.12.2023
France France
Not recruiting
22.12.2023
Germany Germany
Not recruiting
22.12.2023
Greece Greece
Not recruiting
22.12.2023
Hungary Hungary
Not recruiting
22.12.2023
Ireland Ireland
Not recruiting
22.12.2023
Italy Italy
Not recruiting
22.12.2023
Lithuania Lithuania
Not recruiting
22.12.2023
Poland Poland
Not recruiting
22.12.2023
Portugal Portugal
Not recruiting
22.12.2023
Romania Romania
Not recruiting
22.12.2023
Slovakia Slovakia
Not recruiting
22.12.2023
Slovenia Slovenia
Not recruiting
22.12.2023
Spain Spain
Not recruiting
22.12.2023

Trial locations

Andexanet Alfa is a medication used in this clinical trial to help control bleeding in patients who are taking certain blood thinners known as Factor Xa inhibitors. When patients on these blood thinners need urgent surgery or a medical procedure, there is a risk of excessive bleeding. Andexanet Alfa works by reversing the effects of the blood thinners, helping to stop or reduce bleeding during the surgery or procedure.

Reversal of anticoagulation effect in patients on a FXa inhibitor – This condition involves the need to counteract the effects of anticoagulant medications, specifically FXa inhibitors like apixaban, rivaroxaban, or edoxaban. These medications are used to prevent blood clots but can increase the risk of bleeding, especially during urgent surgeries or procedures. The progression of this condition is characterized by the need for rapid intervention to manage bleeding risks. The anticoagulation effect must be reversed to ensure safe surgical outcomes. This process involves restoring the blood’s ability to clot effectively. The condition is not classified as a rare disease.

Trial ID:
2022-501353-37-00
Protocol code:
D9604C00001
Trial Phase:
Therapeutic confirmatory (Phase III)

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