Hypertrophic Cardiomyopathy (HCM)Phase 3LA-HCMNCT07202897
LA-HCM Study : Rivaroxaban for Antithrombotic Prevention in Hypertrophic Cardiomyopathy Patients With Abnormal Left Atrial Strain.
A Phase 3 study testing Anticoagulant treatment Rivaroxaban and Best medical therapy in people with Hypertrophic Cardiomyopathy (HCM), run by Rennes University Hospital at 17 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Hypertrophic Cardiomyopathy (HCM)
- What is being tested?
- Anticoagulant treatment Rivaroxaban and Best medical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 532 participants
- Where
- 17 sitesFrance
- Study dates
- 7 Jan 2026to 7 Jan 2033
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
ganivet anne contact
17 sites in 1 country
France17 sites, 17 recruiting
- Not yet recruiting
CHU Angers
Angers
Loïc BIERE
- Not yet recruiting
CHU Bordeaux Haut-Levêque
Bordeaux
Patricia Reant, Pr
- Not yet recruiting
CHU Brest - Hôpital La Cavale Blanche
Brest
Ombeline PAGLIA
- Not yet recruiting
CHU Caen
Caen
Fabien LABOMBARDA
- Recruiting
CHU Dijon - Hôpital François Mitterrand
Dijon
Jean-Christophe EICHER
- Not yet recruiting
CHU Grenoble Alpes
Grenoble
Gilles Barone-Rochette, Pr
- Not yet recruiting
CHU Lille
Lille
RIDON Hélène
- Not yet recruiting
APHM - Hôpital La Timone
Marseille
HABIB Gilbert
- Not yet recruiting
CHU de Nantes -Hôpital Nord Laennec
Nantes, 44800
Nicolas PIRIOU
- Not yet recruiting
AP-HP Höpital la Pitié-Salpétrière
Paris
Philippe CHARRON
- Not yet recruiting
APHP Hopital Européen Georges Pompidou
Paris
Nadia AISSAOUI
- Not yet recruiting
APHP, Hôpital Lariboisière
Paris
Damien LOGEART
- Recruiting
CHU Rennes - Hôpital Pontchaillou
Rennes
DONAL Erwan
- Not yet recruiting
CHU de Rouen
Rouen, 76000
Charles FAUVEL
- Not yet recruiting
CHU Rangueil Toulouse
Toulouse
Eve Cariou
- Not yet recruiting
CHU de TOURS - HOPITAL TROUSSEAU
Tours, 37044
Anne BERNARD
- Not yet recruiting
CHU Nancy
Vandœuvre-lès-Nancy
Olivier HUTTIN
About this study
Official title: LA-HCM Study : Rivaroxaban for Antithrombotic Prevention in Hypertrophic Cardiomyopathy Patients With Abnormal Left Atrial Strain: A Randomized Multicenter Trial
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.
Read more
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.
- Conditions
- Hypertrophic Cardiomyopathy (HCM)
- Being tested
- Anticoagulant treatment Rivaroxaban, Best medical therapy
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anticoagulant treatment RivaroxabanDrug
Anticoagulant treatment Rivaroxaban in addition to best medical therapy
Best medical therapyOther
Best medical therapy alone
| Study group | Role | What they receive |
|---|---|---|
| Anticoagulant treatment Rivaroxaban | Experimental | Not described Receives: Drug: Anticoagulant treatment Rivaroxaban |
| Best medical therapy | Active comparator | Not described Receives: Other: Best medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause death, myocardial infarction, stroke and systemic embolism
Measured: 2 years
Secondary outcomes (5)
Bleeding
Number of observed bleeding divided by the sum of person-time at risk
Measured: 2 years
Ischemic endpoints and bleeding to estimate the net clinical benefit
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
Measured: 2 years
Atrial arrhythmias
Measured: 2 years
Left Atrial reservoir strain
Measured: 2 years
Kansas City Cardiomyopathy Questionnaire
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start7 Jan 2026
- Primary completion7 Jan 2032 (estimated)
- Study completion7 Jan 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic Cardiomyopathy (HCM)Studies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 532 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Donal Erwan, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07202897
- Sponsor's protocol ID
- 35RC22_9771_LA-HCM
- Other IDs
- 2024-511084-28-00
- Acronym
- LA-HCM
- Status last verified
- Jun 2026
- First submitted
- 15 Sep 2025
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LA-HCM Study : Rivaroxaban for Antithrombotic Prevention in Hypertrophic Cardiomyopathy Patients With Abnormal Left Atrial Strain: A Randomized Multicenter Trial
- ClinicalTrials.gov ID
- NCT07202897
- Acronym / sponsor ID
- LA-HCM / 35RC22_9771_LA-HCM
- Conditions
- Hypertrophic Cardiomyopathy (HCM)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 532 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 7 Jan 2026 (actual)
- Primary completion
- 7 Jan 2032 (estimated)
- Study completion
- 7 Jan 2033 (estimated)
- First posted
- 2 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anticoagulant treatment Rivaroxaban | Experimental | Drug: Anticoagulant treatment Rivaroxaban |
| Best medical therapy | Active comparator | Other: Best medical therapy |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (21 listed)
- Secondary hypertrophic cardiomyopathy (aortic stenosis, hypertension, amyloidosis and all phenocopies…)
- Signs of heart failure
- Hospitalization
- Uncontrolled blood pressure
- Creatinine clearance <30 mL/min (Cockcroft)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anticoagulant treatment RivaroxabanAnticoagulant treatment Rivaroxaban in addition to best medical therapy | Drug | Anticoagulant treatment Rivaroxaban |
| Best medical therapyBest medical therapy alone | Other | Best medical therapy |
Primary outcome
all-cause death, myocardial infarction, stroke and systemic embolism
Time frame: 2 years
5 secondary outcomes
Bleeding
Time frame: 2 years
Ischemic endpoints and bleeding to estimate the net clinical benefit
Time frame: 2 years
Atrial arrhythmias
Time frame: 2 years
Left Atrial reservoir strain
Time frame: 2 years
Kansas City Cardiomyopathy Questionnaire
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ganivet anne contact
Donal Erwan principal investigator
Rennes University Hospital
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anticoagulant treatment Rivaroxaban and Best medical therapy in people with Hypertrophic Cardiomyopathy (HCM), run by Rennes University Hospital at 17 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Courpron Julie (02 99 28 25 55, dri@chu-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all-cause death, myocardial infarction, stroke and systemic embolism (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.