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NCT Number: NCT07202897

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

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.

Recruiting

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Angers, Angers, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Secondary hypertrophic cardiomyopathy (aortic stenosis, hypertension, amyloidosis and all phenocopies…)
  • Signs of heart failure
  • Hospitalization
  • Uncontrolled blood pressure
  • Creatinine clearance <30 mL/min (Cockcroft)
  • Severe liver dysfunction, cirrhosis Child B or C
  • Any anticoagulation therapy in the 15 days prior to enrollment
  • Any cardiac surgery in the 30 days prior to enrollment
  • Documented atrial arrhythmia
  • Any major bleeding in the 90 days prior to enrollment
  • Need to be on dual antiplatelet therapy (aspirin >100 mg daily and a P2Y12 inhibitor, i.e. clopidogrel, ticagrelor, prasugrel…).
  • Contraindication for a brain magnetic resonance imaging exam
  • Known hypersensitivity or others contraindications to Rivaroxaban (refer to contraindications)
  • Ischemic stroke or intracranial hemorrhage in the 30 days prior to enrollment
  • Active endocarditis at the time of enrollment
  • Concomitant combined strong P-gp and CYP3A4 inducers or inhibitors
  • Active cancer or life expectancy less than 3 years
  • Non-compliant
  • Participation in another interventional clinical trial
  • 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)
  • Absence of coverage by a social security scheme

Treatment and study plan

Anticoagulant treatment Rivaroxaban

Drug

Anticoagulant treatment Rivaroxaban in addition to best medical therapy

best medical therapy

Other

Best medical therapy alone

Primary outcomes

  1. all-cause death, myocardial infarction, stroke and systemic embolism

    Time frame: 2 years

Secondary outcomes

  1. Bleeding

    Time frame: 2 years

    Number of observed bleeding divided by the sum of person-time at risk

  2. Ischemic endpoints and bleeding to estimate the net clinical benefit

    Time frame: 2 years

    The net clinical benefit is calculated by subtracting the rate of excess bleeding events attributable to the experimental arm from the rate of excess ischemic events possibly prevented by the experimental arm

  3. Atrial arrhythmias

    Time frame: 2 years

  4. Left Atrial reservoir strain

    Time frame: 2 years

  5. Kansas City Cardiomyopathy Questionnaire

    Time frame: 2 years

    score between 0 and 100. A high score indicates a better quality of life and a lower score indicates a deterioration in quality of life

Study contacts

Contact information is provided by the study sponsor or research team.

Courpron Julie

CONTACT

[email protected]

02 99 28 25 55

ganivet anne

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

LA-HCM Study : Rivaroxaban for Antithrombotic Prevention in Hypertrophic Cardiomyopathy Patients With Abnormal Left Atrial Strain: A Randomized Multicenter Trial

Acronym: LA-HCM

Important dates

Study start
2026
Primary completion
2032
Study completion
2033
First posted
Oct 2, 2025
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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