Status:
NOT_YET_RECRUITING
LA-HCM Study : Rivaroxaban for Antithrombotic Prevention in Hypertrophic Cardiomyopathy Patients With Abnormal Left Atrial Strain.
Lead Sponsor:
Rennes University Hospital
Conditions:
Hypertrophic Cardiomyopathy (HCM)
Eligibility:
All Genders
40-80 years
Phase:
PHASE3
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 pheno...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2030
Estimated Enrollment :
532 Patients enrolled
Trial Details
Trial ID
NCT07202897
Start Date
October 1 2025
End Date
October 1 2030
Last Update
October 2 2025
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