Could a simple blood thinner stop strokes before they start in heart disease patients?
NCT ID NCT07202897
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether the blood thinner rivaroxaban can prevent strokes, heart attacks, and death in people with hypertrophic cardiomyopathy (HCM) who have early signs of atrial damage but normal heart rhythm. About 532 adults aged 40-80 with HCM and reduced left atrial strain will be randomly assigned to rivaroxaban or a placebo. The goal is to see if early treatment can reduce serious events before atrial fibrillation develops.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 532 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Jan 2033
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
17 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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AP-HP Höpital la Pitié-Salpétrière
NOT_YET_RECRUITINGParis, France
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APHM - Hôpital La Timone
NOT_YET_RECRUITINGMarseille, France
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APHP Hopital Européen Georges Pompidou
NOT_YET_RECRUITINGParis, France
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APHP, Hôpital Lariboisière
NOT_YET_RECRUITINGParis, France
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CHU Angers
NOT_YET_RECRUITINGAngers, France
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CHU Bordeaux Haut-Levêque
NOT_YET_RECRUITINGBordeaux, France
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CHU Brest - Hôpital La Cavale Blanche
NOT_YET_RECRUITINGBrest, France
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CHU Caen
NOT_YET_RECRUITINGCaen, France
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CHU Dijon - Hôpital François Mitterrand
RECRUITINGDijon, France
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CHU Grenoble Alpes
NOT_YET_RECRUITINGGrenoble, France
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CHU Lille
NOT_YET_RECRUITINGLille, France
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CHU Nancy
NOT_YET_RECRUITINGVandœuvre-lès-Nancy, France
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CHU Rangueil Toulouse
NOT_YET_RECRUITINGToulouse, France
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CHU Rennes - Hôpital Pontchaillou
RECRUITINGRennes, France
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CHU de Nantes -Hôpital Nord Laennec
NOT_YET_RECRUITINGNantes, 44800, France
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CHU de Rouen
NOT_YET_RECRUITINGRouen, 76000, France
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CHU de TOURS - HOPITAL TROUSSEAU
NOT_YET_RECRUITINGTours, 37044, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- 3,000 hearts, one goal: mapping how hypertrophic cardiomyopathy unfolds in china
- Heart scan AI could predict sudden cardiac death risk in common heart condition
- Experimental pill aims to ease thick heart muscle symptoms
- Massive HCM database aims to unlock better heart care
- Heart drug swap tested for safer symptom control
- Real-World HCM drug use under the microscope