Study of Rivaroxaban versus standard care in patients with excessive atrial ectopy or short atrial runs who have high risk of blood clots

1 1 1 1

What is this study about?

This study focuses on patients with excessive supraventricular ectopies (irregular heartbeats originating above the heart’s lower chambers) or short atrial runs (brief episodes of rapid heartbeats) who are at high risk of blood clots. The study will test the medication rivaroxaban, a blood-thinning drug, compared to standard treatment methods to prevent stroke and blood clots in other parts of the body.

The purpose of this research is to determine how well rivaroxaban works and how safe it is when used long-term in preventing strokes and blood clots, compared to usual care methods. The study will also monitor for any major bleeding events that might occur during treatment. Participants will take either rivaroxaban tablets or receive standard care treatment for a period of 24 months.

During the study, patients will undergo regular check-ups and will have MRI (magnetic resonance imaging) scans of their brain at the beginning and end of the study. The research will track any occurrences of stroke or blood clots, as well as monitor for bleeding complications. Patients will also have their heart rhythm checked using Holter ECG monitoring (a portable device that records heart activity) at various points during the study.

1 Initial screening

Your eligibility for the study will be confirmed if you are 65 years or older and have been diagnosed with excessive heart rhythm irregularities.

A brain scan (MRI) will be performed to establish your baseline condition.

Your risk of blood clots will be evaluated using a special scoring system called CHA2DS2VASC, which must be 3 or higher for participation.

2 Treatment assignment

You will be assigned to receive either rivaroxaban (a blood-thinning medication) or standard care.

The medication is to be taken by mouth as prescribed.

3 Follow-up at 1 year

A heart rhythm test (24-hour ECG Holter) will be conducted to monitor your heart’s electrical activity.

Your health status will be evaluated to check for any heart-related events or bleeding.

4 Final assessment at 2 years

Another brain scan (MRI) will be performed to compare with your initial scan.

A final heart rhythm test (24-hour ECG Holter) will be conducted.

Your cognitive function will be assessed using a standard memory test.

The study team will record any health events that occurred during the study period.

5 Monitoring throughout the study

Regular checks for any signs of stroke or blood clots in other parts of your body.

Monitoring for any bleeding events, which will be classified according to their severity.

Assessment of any changes in your heart rhythm, particularly the development of irregular heartbeat (atrial fibrillation).

Who Can Join the Study?

Must be 65 years or older
Must have excessive irregular heartbeats originating from the upper heart chambers, shown by either:
- At least 1% premature heartbeats or groups of 20 or more irregular beats (lasting less than 30 seconds) during a 24-hour heart monitoring test
- Or groups of 20 or more irregular beats (lasting less than 30 seconds) during a 15-21 day heart monitoring test
Must have a high risk of blood clots (CHA2DS2VASC score of 3 or higher)
Must provide written consent to participate in the study
Must be able to attend all required appointments and undergo brain MRI scans at the start and after 24 months
Must be able to understand and follow the study requirements
Must have social security coverage

Who Cannot Join the Study?

History of atrial fibrillation (irregular heart rhythm lasting longer than 30 seconds)
Active bleeding or high risk of bleeding that would make blood thinning medication unsafe
Recent stroke or blood clot in the last 6 months
Severe liver disease affecting blood clotting
Severe kidney disease (creatinine clearance less than 30 mL/min)
Currently taking blood thinning medications for other conditions
Uncontrolled high blood pressure (systolic >180 mmHg or diastolic >100 mmHg)
Pregnant women or women planning pregnancy during the study period
Active cancer requiring treatment
Recent major surgery within the last month
Inability to comply with study procedures or follow-up visits
Participation in another clinical trial within the last 30 days
Known allergy or intolerance to rivaroxaban (the study medication)
Life expectancy less than 2 years due to other medical conditions

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Clinique Pasteur	Toulouse	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
Oncopole Claudius Regaud	Toulouse	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Les Hopitaux De Chartres	Le Coudray	France
Centre Hospitalier Du Pays D Aix Centre Hospitalier Intercommunal Aix-Pertuis	Aix En Provence	France
Hopital Beaujon	Clichy	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Cspmzj Hxrbfhbxpla Unvaxwcfdgjrm Du Dnkwb	Dijon	France
Hnolxhi Jdsgqv Cpbzond Mlwkb	Massy	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	18.04.2023

Trial locations

Investigated drugs:

Rivaroxaban is a blood-thinning medication (anticoagulant) that helps prevent blood clots from forming. It’s used to reduce the risk of stroke and blood clots in patients with irregular heart rhythms or heart conditions. This medication works by blocking specific proteins in your blood that are involved in forming blood clots.

Standard of Care (SOC) in this context typically refers to the currently accepted treatment methods for patients with similar heart conditions. This may include other blood thinners like warfarin or aspirin, depending on the individual patient’s needs and risk factors.

Investigated diseases:

Atrial fibrillation

Supraventricular Ectopy – A heart rhythm condition where extra heartbeats originate in the upper chambers of the heart (atria). These premature beats disrupt the normal heart rhythm and can occur as single beats or in short runs. The condition is characterized by premature atrial contractions (PACs) that make up 1% or more of total heartbeats in a 24-hour period. In some cases, multiple PACs can occur in sequence, forming short runs of abnormal rhythm.

Peripheral Embolism – A condition where a blood clot travels through the bloodstream and blocks a blood vessel in a part of the body away from the heart. It commonly affects the arms, legs, or other organs. The blockage reduces blood flow to the affected area, causing tissue damage.

Atrial Fibrillation – An irregular heart rhythm where the upper chambers of the heart beat chaotically and irregularly. This disrupts normal blood flow through the heart and can lead to the formation of blood clots. The heart’s electrical signals become disorganized, causing an irregular and often rapid heartbeat.

Trial ID:

2024-516374-29-00

Protocol code:

APHP200002

NCT ID:

NCT05487950

Trial Phase:

Human Pharmacology (Phase I) – Other

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study of Rivaroxaban versus standard care in patients with excessive atrial ectopy or short atrial runs who have high risk of blood clots

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?