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LA-HCM : Direct oral anticoagulant for Antithrombotic Management in patients with Hypertrophic Cardiomyopathies

Status
Recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-511084-28-00
Acronym
2024-511084-28
Enrollment
532
Registered
2025-07-18
Start date
2026-01-12
Completion date
Unknown
Last updated
2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertrophic Cardiomyopathie

Brief summary

Composite endpoint including : a net clinical endpoint death, a composite ischemic endpoint [myocardial infarction, stroke (including asymptomatic event documented on a magnetic resonance imaging), systemic embolism] and bleeding (ISTH major and non-major clinically relevant bleeding)"

Detailed description

Composite endpoints, component of the primary composite outcome, are bleeding (ISTH major and non-major clinically relevant bleeding (ISTH-SSC Bleeding Assessment Tool), BARC classifications), ischemic endpoints (myocardial infarction, stroke (including asymptomatic event documented on a magnetic resonance imaging, systemic embolism) and all cause-death, Atrial arrhythmias identified through ECG/holter monitoring, Left Atrial reservoir strain, Kansas City Cardiomyopathy Questionnaire (KCCQ)

Interventions

DRUGRIVAROXABAN EG 15 mg
DRUGcomprimé pelliculé
DRUGRIVAROXABAN EG 20 mg

Sponsors

Centre Hospitalier Universitaire De Rennes
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Composite endpoint including : a net clinical endpoint death, a composite ischemic endpoint [myocardial infarction, stroke (including asymptomatic event documented on a magnetic resonance imaging), systemic embolism] and bleeding (ISTH major and non-major clinically relevant bleeding)"

Secondary

MeasureTime frame
Composite endpoints, component of the primary composite outcome, are bleeding (ISTH major and non-major clinically relevant bleeding (ISTH-SSC Bleeding Assessment Tool), BARC classifications), ischemic endpoints (myocardial infarction, stroke (including asymptomatic event documented on a magnetic resonance imaging, systemic embolism) and all cause-death, Atrial arrhythmias identified through ECG/holter monitoring, Left Atrial reservoir strain, Kansas City Cardiomyopathy Questionnaire (KCCQ)

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026