Study on the Safety and Tolerability of Abelacimab Compared to Rivaroxaban in Patients with Atrial Fibrillation

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What is this study about?

This clinical trial is focused on studying a heart condition known as Atrial Fibrillation, which causes an irregular and abnormally fast heart rate. The study aims to compare the safety and how well two different treatments are tolerated. The treatments being compared are a study drug called Abelacimab (also known by its code name MAA868) and another drug called Rivaroxaban. Abelacimab is given as a solution for infusion, which means it is administered through a needle into a vein, while Rivaroxaban is taken as film-coated tablets by mouth.

The purpose of the study is to evaluate the effect of Abelacimab compared to Rivaroxaban on the rate of major or clinically relevant non-major bleeding events. Participants in the study will receive either Abelacimab or Rivaroxaban and will be monitored over a period of time to observe any bleeding events that occur. The study will help determine which treatment is safer and better tolerated for patients with atrial fibrillation.

Throughout the study, participants will be closely observed to track the time to the first occurrence of major bleeding events as defined by the International Society on Thrombosis and Haemostasis (ISTH). The study will also look at the time to the first occurrence of major or minor bleeding events. This information will help healthcare professionals understand the safety profile of Abelacimab compared to Rivaroxaban in managing atrial fibrillation.

1 joining the study

Upon joining the study, the patient will be required to provide written informed consent. This is a formal agreement to participate in the trial after understanding its purpose and procedures.

2 initial assessment

An initial assessment will be conducted to confirm eligibility. This includes verifying age, medical history of atrial fibrillation, and other health criteria.

3 randomization

The patient will be randomly assigned to receive either the study drug abelacimab or the comparator drug rivaroxaban.

4 medication administration

If assigned to abelacimab, the patient will receive a 150 mg/ml solution for infusion, administered subcutaneously. The frequency and duration will be specified by the study protocol.

If assigned to rivaroxaban, the patient will take either 20 mg or 15 mg film-coated tablets orally. The dosage and frequency will be determined based on individual health needs and study guidelines.

5 monitoring and follow-up

Regular monitoring will occur to evaluate the safety and tolerability of the medication. This includes checking for any bleeding events and other side effects.

Follow-up visits will be scheduled to assess the patient’s health status and response to the treatment.

6 extension period

If the patient continues with the study treatment at the end of the trial, they may enter an extension period. Consent will be required to participate in this phase.

7 completion of the trial

The trial is estimated to end by October 23, 2025. Upon completion, a final assessment will be conducted to evaluate the overall outcomes and any long-term effects of the treatment.

Who Can Join the Study?

  • Able to provide written informed consent before the first study assessment is performed. This means you agree to participate and understand what the study involves.
  • Male and female patients who are 55 years old or older.
  • Have a history of Atrial Fibrillation (AF) or atrial flutter with planned long-term use of blood-thinning medication. Patients with newly diagnosed AF can also join.
  • Have a CHA2DS2-VASc score of 4 or higher, or a score of 3 with at least one of the following conditions:
    • Planned use of antiplatelet medication (like aspirin or P2Y12 inhibitors) during the trial.
    • Creatinine clearance (CrCl) of 50 ml/min or less using the Cockcroft-Gault equation, which is a way to measure kidney function.
  • For the extension period of the study, you must be continuing the study treatment from the randomized part of the trial at the end of treatment visit.
  • For the extension period, you must be able to provide written informed consent to continue in this part of the study.

Who Cannot Join the Study?

  • Patients with a history of bleeding disorders. This means any condition that makes it hard for the blood to clot, leading to excessive bleeding.
  • Patients who have had a stroke in the past 6 months. A stroke is when blood flow to a part of the brain is stopped, causing brain cells to die.
  • Patients with severe liver disease. The liver is an organ that helps with digestion and removing toxins from the body. Severe disease means the liver is not working well.
  • Patients with kidney disease that requires dialysis. Dialysis is a treatment that does the work of the kidneys when they are not functioning properly.
  • Patients who are currently taking other anticoagulant medications. These are drugs that help prevent blood clots.
  • Patients with uncontrolled high blood pressure. This means blood pressure that is consistently too high and not managed by medication or lifestyle changes.
  • Patients who are pregnant or breastfeeding. This is to ensure the safety of both the mother and the baby.
  • Patients with a known allergy to the study drugs. An allergy is when the body’s immune system reacts to a substance as if it is harmful.
  • Patients who have participated in another clinical trial within the last 30 days. This is to avoid any interference with the results of the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Central Hospital Of Northern Pest Military Hospital Budapest Hungary
Borbanya Praxis Egeszsegugyi Kft. Nyiregyhaza Hungary
Kardiologicka ambulance MUDr. Ferkl s.r.o. Horni Predmesti Czechia
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Warsaw Poland
DRC Kft. Balatonfured Hungary
Lunacor s.r.o. Kromeriz Czechia
1 Wojskowy Szpital Kliniczny Z Poliklinika samodzielny publiczny zakład opieki zdrowotnej W Lublinie Lublin Poland
Belinus Bt. Debrecen Hungary
Obudai Egeszseguegyi Centrum Kft. Dunaújváros Hungary
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz Szekesfehervar Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz Kaposvar Hungary
Clinexpert Kft. Budapest Hungary
Medicus Services s.r.o. Brandys Nad Labem Czechia
Nemocnice Slany Slany Czechia
Semmelweis University Budapest Hungary
Centrum Badan Klinicznych Piotr Napora Lekarze sp.p. Wroclaw Poland
Cardiomobile Kft. Balatonfured Hungary
American Heart Of Poland S.A. Kedzierzyn-Kozle Poland
InterKardioML s.r.o. Marianske Lazne Czechia
Medifarma-98 Kft. Nyiregyhaza Hungary
Ko-Med Centra Kliniczne Sp. z o.o. Lublin Poland
Polabská zdravotní s.r.o. Podebrady Czechia
DermaMed Research Kft. Oroshaza Hungary
Nemocnice Na Frantisku Prague Czechia
Corintez s.r.o. Prague Czechia
Knuxbaqhv Johxpqhhzl Oooqsqvfv Pjumrnxj Rsorph Sasgscggwb Wigrtc Lgphiuh Skm pf Elblag Poland
1 Npqs Pau Cedmns Sgleeygt Chgfqrw Bmoso Khrnaphveuhvefxg Pmwai Mwsvlg Gdynia Poland
Piiblottjhwzcg supfnd Pardubice Czechia
Keggiw Sizqg slpzvo Ceska Lipa Czechia
Kgywdehkxhh Vuoxndswb shzboh Prague Czechia
Lifxdcf Kipz Baja Hungary
Anycczx Cdjftdy Svn z opyx Syfw Ruda Slaska Poland
Iapzcrzcicir Syeeqfbzskjaicr Pbpkeuio Lndidsve w dimsclizlq kkqiziqzsrf Lbh myyd Kdmbrregd Crnorcqc Gdynia Poland
Wqvslcatcf Sfrcyzr Imv Ssxnrhi Pss W Ppfbskpzz Przemysl Poland
Kjissiwmw Snpnpbj Snsxeftidammpdn ix Jhxi Pcidu Ix Cracow Poland

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

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
23.01.2021
Hungary Hungary
Not recruiting
23.01.2021
Poland Poland
Not recruiting
23.01.2021

Trial locations

Investigated drugs:

Abelacimab is a medication being studied for its ability to reduce bleeding events in patients with atrial fibrillation. It is being tested in two different doses to see how well it works and how safe it is for patients. The goal is to find out if it can be a better option compared to other treatments.

Rivaroxaban is a medication that is already used to prevent blood clots in patients with atrial fibrillation. In this study, it is used as a comparison to see how well abelacimab performs in reducing bleeding events. Rivaroxaban helps to prevent strokes and other complications by thinning the blood.

Investigated diseases:

Atrial Fibrillation – Atrial fibrillation is a common heart rhythm disorder where the heart’s upper chambers (atria) beat irregularly and often rapidly. This irregular rhythm can lead to poor blood flow and may cause symptoms such as palpitations, shortness of breath, and fatigue. The condition can vary in duration, with some episodes lasting minutes and others persisting for longer periods. Over time, atrial fibrillation can lead to complications such as blood clots, which may increase the risk of stroke. The progression of the disease can be influenced by factors like age, underlying heart conditions, and lifestyle. Managing atrial fibrillation often involves monitoring the heart’s rhythm and addressing any contributing health issues.

Trial ID:
2023-509066-38-00
Protocol code:
CMAA8682204(ANT-006)
Trial Phase:
Therapeutic exploratory (Phase II)

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