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

NCT07202897 | Not Yet Recruiting Phase 3 DMC

• 2 other identifiers: 35RC22_9771_LA-HCM2024-511084-28-00
• Study Type: interventional
• Target: 532
• Locations: 0 countries
• Sites: N/A

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)

Outcome Measures

Primary Outcomes (1)

• all-cause death, myocardial infarction, stroke and systemic embolism

  2 years

Secondary Outcomes (5)

• Bleeding

  2 years

• Ischemic endpoints and bleeding to estimate the net clinical benefit

  2 years

• Atrial arrhythmias

  2 years

• Left Atrial reservoir strain

  2 years

• Kansas City Cardiomyopathy Questionnaire

  2 years

Study Arms (2)

Anticoagulant treatment Rivaroxaban

EXPERIMENTAL

Drug: Anticoagulant treatment Rivaroxaban

Best medical therapy

ACTIVE COMPARATOR

Other: Best medical therapy

Interventions

Anticoagulant treatment Rivaroxaban DRUG

Anticoagulant treatment Rivaroxaban in addition to best medical therapy

Anticoagulant treatment Rivaroxaban

Best medical therapy OTHER

Best medical therapy alone

Best medical therapy

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rennes University Hospital: lead

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: October 2, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2030
• Last Updated: October 2, 2025

Record last verified: 2025-09