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Phase 3
Age: 40Years - 80Years
All Genders
ID07202897

Study of Rivaroxaban to Prevent Blood Clots in Adults Aged 40 to 80 With Hypertrophic Cardiomyopathy and Low Left Atrial Strain

Led by Rennes University Hospital · Updated on 2026-06-12

532

Participants Needed

17

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Hypertrophic cardiomyopathy HCM is a common genetic heart condition affecting adults, with symptoms and risks varying widely among patients. Atrial fibrillation AF, a frequent complication of HCM, can severely impact quality of life and increase risks of stroke and sudden cardiac death. Current observational studies have identified markers like left atrial strain LA-strain that may help predict stroke and AF risk, suggesting a need to explore preventive therapies for patients in sinus rhythm but at risk for AF. This research evaluates anticoagulant treatment with Rivaroxaban compared to best medical therapy in adults aged 40 to 80 years with HCM and abnormal LA-strain 20% or less. Participants will be randomly assigned to receive either Rivaroxaban plus standard care or standard care alone. The study is a randomized, multicenter, phase 3 trial focused on preventing major cardiovascular events. Participants will be monitored over two years for outcomes including death, myocardial infarction, stroke, embolism, bleeding, atrial arrhythmias, and quality of life measures. Assessments include cardiac imaging to measure LA strain and questionnaires to evaluate heart failure impact. The study tracks safety and efficacy, with regular follow-ups to observe clinical events and treatment effects throughout the trial period.

CONDITIONS

Brief Title

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

Research Team

C

Courpron Julie

G

ganivet anne

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