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

NCT ID: NCT07202897

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 532 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2030-10-01

Brief 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.

Conditions

Hypertrophic Cardiomyopathy (HCM)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Anticoagulant treatment Rivaroxaban

Group Type: EXPERIMENTAL

Anticoagulant treatment Rivaroxaban

Intervention Type: DRUG

Anticoagulant treatment Rivaroxaban in addition to best medical therapy

Best medical therapy

Group Type: ACTIVE_COMPARATOR

Best medical therapy

Intervention Type: OTHER

Best medical therapy alone

Interventions

Anticoagulant treatment Rivaroxaban

Anticoagulant treatment Rivaroxaban in addition to best medical therapy

Intervention Type: DRUG

Best medical therapy

Best medical therapy alone

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2024-511084-28-00

Identifier Type: CTIS

Identifier Source: secondary_id

35RC22_9771_LA-HCM

Identifier Type: -

Identifier Source: org_study_id