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Clinical Trials in France / NCT07202897
Recruiting Phase 3

LA-HCM Study : Rivaroxaban for Antithrombotic Prevention in Hypertrophic Cardiomyopathy Patients With Abnormal Left Atrial Strain.

NCT07202897 · tracked via the Priya Life Science France tracker
Sponsor
Rennes University Hospital
Phase
Phase 3
Started
2026-01-07
Last updated
2026-06-12

Condition(s) studied

Hypertrophic Cardiomyopathy (HCM)

Investigational drug(s) / intervention(s)

Anticoagulant treatment RivaroxabanBest medical therapy

Anticoagulant treatment Rivaroxaban: Anticoagulant treatment Rivaroxaban in addition to best medical therapy

Best medical therapy: Best medical therapy alone

Study 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.

Eligibility

Sex
ALL
Min age
40 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. 40 - 80 years of age 2. 50 and 120 kg of weight 3. In sinus rhythm 4. Prior confirmed diagnosis of "primary" hypertrophic cardiomyopathy 5. Left Atrial reservoir strain measured ≤20% (corelab confirmation) 6. Signature of an informed consent 7. 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: 1. Secondary hypertrophic cardiomyopathy (aortic stenosis, hypertension, amyloidosis and all phenocopies…) 2. Signs of heart failure 3. Hospitalization 4. Uncontrolled blood pressure 5. Creatinine clearance \<30 mL/min (Cockcroft) 6. Severe liver dysfunction, cirrhosis Child B or C 7. Any anticoagulation therapy in the 15 days prior to enrollment 8. Any cardiac surgery in the 30 days prior to enrollment 9. Documented atrial arrhythmia 10. Any major bleeding in the 90 days prior to enrollment 11. Need to be on dual antiplatelet therapy (aspirin \>100 mg daily and a P2Y12 inhibitor, i.e. clopidogrel, ticagrelor, prasugrel…). 12. Contraindication for a brain magnetic resonance imaging exam 13. Known hypersensitivity or others contraindications to Rivaroxaban (refer to contraindications) 14. Ischemic stroke or intracranial hemorrhage in the 30 days prior to enrollment 15. Active endocarditis at the time of enrollment 16. Concomitant combined strong P-gp and CYP3A4 inducers or inhibitors 17. Active cancer or life expectancy less than 3 years 18. Non-compliant 19. Participation in another interventional clinical trial 20. Protected person (adults legally protected (under judicial protection, guardianship or supervision), person deprived of their liberty, pregnant woman, lactating woman or planning pregnancy during the study period and minor) 21. Absence of coverage by a social security scheme

Primary outcome measure(s)

Trial sites (17)

FacilityCityRegionStatus
CHU Angers Angers France Not Yet Recruiting
CHU Bordeaux Haut-Levêque Bordeaux France Not Yet Recruiting
CHU Brest - Hôpital La Cavale Blanche Brest France Not Yet Recruiting
CHU Caen Caen France Not Yet Recruiting
CHU Dijon - Hôpital François Mitterrand Dijon France Recruiting
CHU Grenoble Alpes Grenoble France Not Yet Recruiting
CHU Lille Lille France Not Yet Recruiting
APHM - Hôpital La Timone Marseille France Not Yet Recruiting
CHU de Nantes -Hôpital Nord Laennec Nantes France Not Yet Recruiting
AP-HP Höpital la Pitié-Salpétrière Paris France Not Yet Recruiting
APHP Hopital Européen Georges Pompidou Paris France Not Yet Recruiting
APHP, Hôpital Lariboisière Paris France Not Yet Recruiting
CHU Rennes - Hôpital Pontchaillou Rennes France Recruiting
CHU de Rouen Rouen France Not Yet Recruiting
CHU Rangueil Toulouse Toulouse France Not Yet Recruiting
CHU de TOURS - HOPITAL TROUSSEAU Tours France Not Yet Recruiting
CHU Nancy Vandœuvre-lès-Nancy France Not Yet Recruiting

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CLE-PAD : Prevalence of PAD in Patients With Surgically Lumbar Spinal Stenosis Recruiting
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07202897 on ClinicalTrials.gov ↗ ← All trials in France