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Prevention study for Hypertrophic Cardiomyopathy (HCM)
Official title LA-HCM Study : Rivaroxaban for Antithrombotic Prevention in Hypertrophic Cardiomyopathy Patients With Abnormal Left Atrial Strain.
ClinicalTrials.gov ID: NCT07202897
What this study is testing
What is Anticoagulant treatment Rivaroxaban?
Anticoagulant treatment Rivaroxaban is an investigational medicine, being studied as a potential treatment for hypertrophic cardiomyopathy (hcm).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 phenotype as the prognosis of HCM may greatly differ from one patient to another: most patients present no or few symptoms and a near-normal lifespan, while others are severely symptomatic.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join if
- 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)
You likely can't join if
- 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
See the full eligibility criteria
- 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...
- 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 treatment 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...
- Absence of coverage by a social security scheme
The study team makes the final eligibility decision.
Where it's taking place
- Angers, France
- Bordeaux, France
- Brest, France
- Caen, France
- Dijon, France
- Grenoble, France
- Lille, France
- Marseille, France
- Nantes, France
- Paris, France
- Rennes, France
- Rouen, France
- Toulouse, France
- Tours, France
- Vandœuvre-lès-Nancy, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Angers, France; Bordeaux, France; Brest, France; Caen, France; Dijon, France; Grenoble, France and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.