Rivaroxaban for Hypertrophic cardiomyopathy

Inclusion criteria

• {"criterion_text":"- 40 - 80 years of age\n- In sinus rhythm\n- Prior confirmed diagnosis of “primary” hypertrophic cardiomyopathy\n- Left Atrial reservoir strain measured ≤20% (corelab confirmation)\n- Signature of an informed consent\n- 50 and 120 kg of weight\n- 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

• {"criterion_text":"- Secondary hypertrophic cardiomyopathy\n- Signs of heart failure\n- Hospitalization\n- Uncontrolled blood pressure\n- Creatinine clearance <30 mL/min (Cockcroft)\n- Severe liver dysfunction, cirrhosis Child B or C\n- Any anticoagulation therapy in the 15 days prior to enrollment\n- Any cardiac surgery in the 30 days prior to enrollment\n- Documented atrial arrhythmia\n- Any major bleeding in the 90 days prior to enrollment\n- Need to be on dual antiplatelet therapy\n- Contraindication for a brain magnetic resonance imaging exam\n- Known hypersensitivity or others contraindications to Rivaroxaban\n- Ischemic stroke or intracranial hemorrhage in the 30 days prior to enrollment\n- Active endocarditis at the time of enrollment\n- Concomitant combined strong P-gp and CYP3A4 inducers or inhibitors\n- Active cancer or life expectancy less than 3 years\n- Non-compliant\n- Participation in another interventional clinical trial\n- Protected person (adults legally protected (under judicial protection, guardianship or supervision), person deprived of their liberty, pregnant woman, lactating woman and minor)\n- Absence of coverage by a social security scheme"}

Primary endpoints

• {"endpoint_text":"- All-cause death, myocardial infarction, stroke (including new silent brain infarct documented by comparing a magnetic resonance imaging planned for each participant at baseline and 2 years follow-up) and systemic embolism","definition_or_measurement_approach":"Composite of all-cause death, myocardial infarction, stroke and systemic embolism. Stroke includes new silent brain infarct documented by comparison of MRI performed at baseline and at 2 years of follow-up."}

Secondary endpoints

• {"endpoint_text":"- Bleeding (major and non-major clinically relevant bleeding according to ISTH and BARC (Blending Academic Research Consortium) classification) according to strategy allocation, and exposure to anticoagulant","definition_or_measurement_approach":"Bleeding events classified according to ISTH and BARC definitions; assessed according to randomized strategy allocation and anticoagulant exposure."}
• {"endpoint_text":"- Atrial arrhythmias identified through ECG/holter monitoring","definition_or_measurement_approach":"Atrial arrhythmias detected by ECG and Holter monitoring."}
• {"endpoint_text":"- Left Atrial reservoir strain","definition_or_measurement_approach":"Measurement of Left Atrial reservoir strain (including corelab confirmation for inclusion and longitudinal assessment as endpoint)."}
• {"endpoint_text":"- Kansas City Cardiomyopathy Questionnaire (KCCQ)","definition_or_measurement_approach":"Quality-of-life assessment using the KCCQ instrument."}
• {"endpoint_text":"- Ischemic endpoints (myocardial infarction, stroke (including new silent brain infarct documented by comparing a magnetic resonance imaging planned at baseline and 2 years follow-up, systemic embolism) and bleeding (major and non-major clinically relevant bleeding according to ISTH and BARC classification)","definition_or_measurement_approach":"Composite assessment of ischemic events (myocardial infarction, stroke including MRI-detected silent infarcts at baseline vs 2 years, systemic embolism) and bleeding events classified per ISTH and BARC."}

France

Latest Decision Or Authorization Date

15-04-2026

Number Of Sites

17

Number Of Participants

532

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Rennes

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France