Rivaroxaban for preventing problems in adults with hypertrophic cardiomyopathy and abnormal left atrial strain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 interventional trial compares rivaroxaban plus best medical therapy to best medical therapy alone in adults with hypertrophic cardiomyopathy and reduced left atrial reservoir strain. Eligible participants are 40–80 years old, in sinus rhythm, with a confirmed HCM diagnosis and LARS ≤20%, and no significant comorbid conditions that would preclude anticoagulation. The primary aim is to determine whether rivaroxaban reduces thromboembolic events and other anticoagulation-related risks in this specific population. Outcomes will include safety, stroke or systemic embolism, and hospitalizations, among others. The study is led by Rennes University Hospital with several French sites participating.

Why it matters

Who can join: the full rules

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

Where it's running

• CHU Dijon - Hôpital François Mitterrand
  Dijon, France Recruiting
• CHU Rennes - Hôpital Pontchaillou
  Rennes, France Recruiting
• CHU Angers
  Angers, France Not yet recruiting
• CHU Bordeaux Haut-Levêque
  Bordeaux, France Not yet recruiting
• CHU Brest - Hôpital La Cavale Blanche
  Brest, France Not yet recruiting
• CHU Caen
  Caen, France Not yet recruiting

Study contacts

• Principal investigator: Donal Erwan — Rennes University Hospital
• Study coordinator: Courpron Julie
• Email: dri@chu-rennes.fr
• Phone: 02 99 28 25 55

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.