LA-HCM Study : Rivaroxaban for Antithrombotic Prevention in Hypertrophic Cardiomyopathy Patients … (NCT07202897) | Clinical Trial Compass
RecruitingPhase 3
LA-HCM Study : Rivaroxaban for Antithrombotic Prevention in Hypertrophic Cardiomyopathy Patients With Abnormal Left Atrial Strain.
France532 participantsStarted 2026-01-07
Plain-language summary
Hypertrophic cardiomyopathy (HCM) is a common (\> 1/500 in the general adult population) genetically transmitted disease impacting markedly patients' lives from the early ages to the latest. The phenotype as the prognosis of HCM may greatly differ from one patient to another: most patients present no or few symptoms and a near-normal lifespan, while others are severely symptomatic. Paroxysmal, persistent or permanent atrial fibrillation (AF) is frequent in HCM, occurring in more than 20%-25% of patients and is often considered as an important turning point for the quality of life of these patients. AF decreases cardiac output and exercise tolerance, increases hospitalization rate, and markedly increase the risk of embolic stroke with the need for life-anticoagulation. It has been shown that stroke may precede AF discovery and that it may occur at young ages with devastation consequences. AF also may trigger sudden cardiac death.
Observational studies have been conducted to search for parameters which correlate with the risk of AF (P wave duration and supra-ventricular burst on the Holter-ECG monitoring, L-wave morphology, degree of hypertrophy, clinical parameters-comorbidities, and size of the left atrium) with no real impact on clinical management. Left Atrial strain (LA-strain) has been recently demonstrated relevant (for instance our pilot work (for predicting stroke and/or AF (a cut-off of 15% is highly specific, 20% being the optimal cut-off). LA-strain (cut-off 20%) could be used for defining the patients that might require preventive anticoagulation therapy.
A randomized clinical trial is needed to extend the use of anticoagulation therapy to patients in sinus rhythm but identified to be at risk for AF.
Of note, it has been demonstrated that in this population, stroke occurred in 67% of the patients without any clinical atrial arrhythmia.
Who can participate
Age range
40 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 40 - 80 years of age
. 50 and 120 kg of weight
. In sinus rhythm
. Prior confirmed diagnosis of "primary" hypertrophic cardiomyopathy
. Left Atrial reservoir strain measured ≤20% (corelab confirmation)
. Signature of an informed consent
. Highly effective contraceptive methods for women of childbearing potential from at least 14 days prior to start treatment, throughout the study treatment period, and until at least 4 weeks after the last dose of study medication
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing rivaroxaban — a blood thinner — in HCM patients who have abnormal left atrial strain but may not have atrial fibrillation; could my own left atrial strain results or echo findings make this worth discussing as an option for me?
2Since this is a Phase 3 trial measuring serious outcomes like stroke, heart attack, and death, what does my doctor think the current evidence says about the benefit-versus-bleeding-risk tradeoff of adding a blood thinner like rivaroxaban to my existing HCM treatment plan?
3The trial is actively recruiting right now — what would my doctor need to know about my cardiac imaging, heart rhythm history, and overall health before deciding whether it's even worth looking into my eligibility for a study like this?
4If I were to discuss this trial with a specialist, how does taking rivaroxaban in a research setting compare to any anticoagulation my doctor might already consider prescribing me outside of a trial, and what would I be giving up or gaining by going the trial route?
5HCM already puts me at higher risk for certain heart events — does my doctor think my current risk profile is the kind this trial seems to be targeting, and would they recommend I first try to optimize my standard HCM medications before considering an anticoagulation trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
all-cause death, myocardial infarction, stroke and systemic embolism