LA-HCM : Rivaroxaban for Antithrombotic Prevention in Hypertrophic Cardiomyopathy Patients with Abnormal Left Atrial Strain : A Randomized Multicenter Trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Rennes

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

12 Jan 2026 → ongoing

Decision date (initial)

2025-07-18

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

DGOS (PHRC national 2022)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To demonstrate that antithrombotic treatment with Rivaroxaban (new strategy starting Rivaroxaban right now) is superior to standard management (later introduction of anticoagulant if required) in HCM-patients having an abnormal Left Atrial Reservoir Strain (LARS)

Secondary objectives 5

1. To describe the incidence of bleeding
2. To describe atrial arrhythmias and its relation with the documented ischemic events
3. To compare changes in Left Atrial reservoir strain
4. To assess quality of life
5. To estimate the net clinical benefit of the antithrombotic treatment with Rivaroxaban (new strategy starting Rivaroxaban right now) versus standard-of-care arm (later introduction of anticoagulant if required), considering, on the one hand, ischemic event and, on the other hand, bleeding with weighting of the type of events for their impact on death and disability relative to ischemic stroke

Conditions and MedDRA coding

Hypertrophic Cardiomyopathie

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. 40 - 80 years of age
2. In sinus rhythm
3. Prior confirmed diagnosis of “primary” hypertrophic cardiomyopathy
4. Left Atrial reservoir strain measured ≤20% (corelab confirmation)
5. Signature of an informed consent
6. 50 and 120 kg of weight
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 21

1. Secondary hypertrophic cardiomyopathy
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
12. Contraindication for a brain magnetic resonance imaging exam
13. Known hypersensitivity or others contraindications to Rivaroxaban
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 and minor)
21. Absence of coverage by a social security scheme

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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

Secondary endpoints 5

1. 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
2. Atrial arrhythmias identified through ECG/holter monitoring
3. Left Atrial reservoir strain
4. Kansas City Cardiomyopathy Questionnaire (KCCQ)
5. 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)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Rennes

Sponsor organisation

Centre Hospitalier Universitaire De Rennes

Address

2 Rue Henri Le Guilloux

City

Rennes

Postcode

35000

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Rennes

Contact name

DONAL Erwan

Public contact point

Organisation

Centre Hospitalier Universitaire De Rennes

Contact name

DONAL Erwan

Locations

1 EU/EEA country · 17 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 20 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications