Study on Apixaban for Preventing Stroke in Patients with Atrial Fibrillation and Stage 5 Chronic Kidney Disease

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What is this study about?

This clinical trial is focused on studying the effects of the medication Apixaban in patients who have both Atrial Fibrillation and Chronic Kidney Disease stage 5. Atrial Fibrillation is a condition where the heart beats irregularly, and Chronic Kidney Disease stage 5 is the most severe stage of kidney disease, where the kidneys are close to failing or have already failed. The purpose of the study is to see if Apixaban can help prevent strokes in these patients without causing serious bleeding.

Participants in the study will be given Apixaban, which is a type of medication known as an anticoagulant. Anticoagulants help prevent blood clots, which can lead to strokes. The study will compare the effects of taking Apixaban with not taking any anticoagulant medication. Some participants may receive a placebo, which looks like the medication but does not contain any active ingredients. The study will last for a period of up to 72 weeks, during which participants will take the medication orally, meaning they will swallow it in the form of a tablet.

The main goal is to determine if Apixaban can reduce the risk of having an ischemic stroke, which is a type of stroke caused by a blood clot blocking a blood vessel in the brain, or systemic embolism, which is when a blood clot travels to other parts of the body. The study will also monitor for any serious side effects, such as bleeding in the brain or other major bleeding events. Participants will be closely monitored throughout the study to ensure their safety and to gather information on the effectiveness of the treatment.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, you will be asked to provide a signed written informed consent, either on paper or digitally, to confirm your participation.

You will undergo a series of assessments to confirm your eligibility, including a review of your medical history and a physical examination. Women of childbearing potential will need to take a highly sensitive pregnancy test.

2 medication administration

If eligible, you will begin taking the study medication, apixaban, which is a film-coated tablet. The dosage is 2.5 mg, taken orally.

You will take the medication twice daily, once in the morning and once in the evening, for the duration of the study.

3 regular follow-up visits

Throughout the study, you will attend regular follow-up visits. These visits are important to monitor your health and the effects of the medication.

During these visits, you may undergo various tests and assessments, such as blood tests and heart monitoring, to ensure your safety and the effectiveness of the treatment.

4 end of study

At the end of the study, you will have a final visit. This visit will include a comprehensive assessment of your health and a review of your experience during the trial.

You will be provided with information on the next steps and any necessary follow-up care.

Who Can Join the Study?

Must provide a signed written consent, either on paper or digitally, agreeing to participate in the study.
Must be a man or woman aged 18 years or older.
Must be receiving ongoing treatment with any chronic dialysis or have a very low kidney function, measured as an estimated glomerular filtration rate (eGFR) of less than 20 ml/min/1.73 m² at least twice in the past year, with at least one measurement being less than 15 ml/min/1.73 m² due to chronic kidney disease (CKD).
Must have a diagnosis of atrial fibrillation (AF) or atrial flutter (AFL), which are types of irregular heartbeats.
Must have a CHA2DS2-VASc score of 2 or more for men, or 3 or more for women. This score helps determine the need for blood-thinning medication to prevent stroke.
Women who can become pregnant must have a negative pregnancy test before starting the study and must agree to use effective birth control methods during the study.

Who Cannot Join the Study?

Patients with atrial fibrillation (an irregular and often rapid heart rate) and Chronic Kidney Disease stage 5 (the most severe stage of kidney disease) cannot participate if they have certain other medical conditions.
Patients who are currently receiving dialysis treatment (a procedure to remove waste products and excess fluid from the blood when the kidneys stop working properly) may have specific restrictions.
Patients who have a history of intracranial bleeding (bleeding inside the skull) are excluded.
Patients with a high risk of fatal bleeding (bleeding that could lead to death) cannot participate.
Patients who are unable to follow the study procedures or take the study medication as directed are not eligible.
Patients who are pregnant or breastfeeding are excluded from the study.
Patients who are participating in another clinical trial at the same time are not allowed to join this study.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi	Lodz	Poland
Region Oestergoetland	Linkoping	Sweden
Region Vaestmanland	Vasteras	Sweden

Other Sites

Site Name	City	Country
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Oulu University Hospital	Oulu	Finland
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego	Warsaw	Poland
Lovisenberg Diakonale Sykehus AS	Oslo	Norway
Expansion Centres Hemodialyse Ouest	Laval	France
Region Skane Kristianstad Central Hospital	Kristianstad	Sweden
Region Halland	Varberg	Sweden
Malarsjukhuset Eskilstuna	Eskilstuna	Sweden
Wojewodzki Szpital Specjalistyczny W Olsztynie	Olsztyn	Poland
Vaasa Central Hospital	Vaasa	Finland
Universitetssykehuset Nord-Norge HF	Tromsø	Norway
Uniwersytecki Szpital Kliniczny W Bialymstoku	Bialystok	Poland
Vestfold Hospital Trust	Tonsberg	Norway
Tampere University Hospital	Tampere	Finland
Karolinska University Hospital	Solna	Sweden
St. Antonius Ziekenhuis	Nieuwegein	The Netherlands
Oslo University Hospital HF	Oslo	Norway
Turku University Hospital	Turku	Finland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Uniwersytecki Szpital Kliniczny Nr 1 Im Norberta Barlickiego Uniwersytetu Medycznego W Lodzi SPZOZ	Lodz	Poland
Region Kronoberg	Vaxjo	Sweden
Danderyds Sjukhus AB	Danderyd	Sweden
Region Oerebro Laen	Orebro	Sweden
Region Vaesterbotten	Umea	Sweden
Centre Hospitalier Lyon Sud	Pierre Benite	France
Soedra Aelvsborg Hospital Vaestra Goetalandsregionen	Boras	Sweden
St. Olavs Hospital HF	Trondheim	Norway
Region Skane Lasarettet I Ystad	Ystad	Sweden
Drammen Sykehus	Drammen	Norway
Vrinnevisjukhuset I Norrkoeping Region Oestergoetland	Norrkoping	Sweden
Laenssjukhuset I Kalmar Region Kalmar Laen	Kalmar	Sweden
NU Hospital Group-Vaestra Goetalandsregionen	Trollhattan	Sweden
Skaraborg Hospital-Vaestra Goetalandsregionen	Skovde	Sweden
Region Soermland	Nykoping	Sweden
Region Jaemtland Haerjedalen	Ostersund	Sweden
Region Blekinge	Karlskrona	Sweden
Region Norrbotten	Lulea	Sweden
Region Dalarna	Falun	Sweden
Region Vaesternorrland	Sundsvall	Sweden
Region Gaevleborg	Gavle	Sweden
Hoglandssjukhuset Eksjo-Region Jonkopings Lan	Eksjo	Sweden
Państwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i Administracji	Warsaw	Poland
Ayhscihw Uimvztgsvj Hkdmrsjx	Lorenskog	Norway
Rgfpef Jmyztabftm Lhu	Jönköping	Sweden
Sdpjtwlgqtxw	Pori	Finland
Lfffk Cuhikyo Hqdnkwgf	Lahti	Finland
Hevby Slyoxukgg Hj	Stavanger	Norway
Ahev Pdbxa	Saint Ouen Sur Seine	France
Ueltthf Usguzqbhaj Hkryrsvz	Uppsala	Sweden
Hdgzs Bznoaj Hs	Bergen	Norway
Hswbkhaj Uvvwgncgno Cvymiuf Hhyeteze	Helsinki	Finland
Svasogbhwnf Uasmkpgdji Hqjoaomugoviqvs Glowhrkpbzgggrbpo	Gothenburg	Sweden
Rroytw Vmcssnkpd	Karlstad	Sweden
Sdydvjopvrs Pjtionsnp Sgspuba Kqmbzkvbm Ipsmgkdemju Mzwhctrebve Slf W Kpjaansrry	Katowice	Poland

Trial status

Country	Status	Recruitment Start
Finland	Recruiting	01.12.2022
France	Not yet recruiting	01.12.2022
Iceland	Recruiting	01.12.2022
Norway	Recruiting	01.12.2022
Poland	Recruiting	01.12.2022
Sweden	Recruiting	01.12.2022
The Netherlands	Recruiting	01.12.2022

Trial locations

Investigated drugs:

Apixaban

Apixaban is a medication used to prevent blood clots from forming in the body. In this clinical trial, it is being tested to see if it can help reduce the risk of strokes and other serious complications in patients who have a specific type of irregular heartbeat called atrial fibrillation, especially those who also have severe kidney problems. The goal is to find out if taking Apixaban can lower the chances of having a stroke or a clot without causing too much bleeding, which can be a side effect of blood thinners. This medication is being compared to not using any blood-thinning medication to see which approach is safer and more effective for these patients.

Investigated diseases:

Atrial Fibrillation – Atrial fibrillation is a heart condition characterized by an irregular and often rapid heart rate. It occurs when the upper chambers of the heart (atria) beat out of coordination with the lower chambers (ventricles). This can lead to poor blood flow and may cause symptoms like heart palpitations, shortness of breath, and fatigue. Over time, atrial fibrillation can lead to complications such as blood clots, which can increase the risk of stroke. The condition can be persistent or occur in episodes that come and go. It often requires ongoing management to control the heart rate and rhythm.

Chronic Kidney Disease Stage 5 – Chronic Kidney Disease (CKD) stage 5, also known as end-stage renal disease, is the most advanced stage of chronic kidney disease. At this stage, the kidneys have lost nearly all their ability to function effectively, leading to a significant buildup of waste products and fluid in the body. Symptoms may include fatigue, swelling in the legs and ankles, shortness of breath, and difficulty concentrating. The progression to stage 5 often requires interventions to manage the body’s waste products and fluid levels. This stage of CKD can severely impact overall health and quality of life. It typically necessitates ongoing medical care to address the complications associated with kidney failure.

Trial ID:

2022-501600-10-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Apixaban for Preventing Stroke in Patients with Atrial Fibrillation and Stage 5 Chronic Kidney Disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?