2024-511084-28-00招募中4 期
LA-HCM : Direct oral anticoagulant for Antithrombotic Management in patients with Hypertrophic Cardiomyopathies
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 532
- 试验地点
- 15
- 主要终点
- 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)"
研究概览
简要总结
To demonstrate that antithrombotic treatment is superior to standard management in HCM-patients having an abnormal Left Atrial Reservoir Strain (LARS)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •18 - 80 years of age
- •In sinus rhythm
- •Prior confirmed diagnosis of “primary” hypertrophic cardiomyopathy
- •Left Atrial reservoir strain measured ≤20% (corelab confirmation)
- •Signature of an informed consent
排除标准
- •Secondary hypertrophic cardiomyopathy
- •Any major bleeding in the 90 days prior to enrollment
- •Need to be on dual antiplatelet therapy
- •Contraindication for a brain magnetic resonance imaging exam
- •Known hypersensitivity or others contraindications to Rivaroxaban
- •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 interventional clinical trial
- •Signs of heart failure
- •Protected person (adults legally protected (under judicial protection, guardianship or supervision), person deprived of their liberty, pregnant woman, lactating woman and minor)
- •Absence of coverage by a social security scheme
- •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
结局指标
主要结局
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)"
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)"
次要结局
- 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)
研究者
DONAL Erwan
Scientific
Centre Hospitalier Universitaire De Rennes
研究点 (15)
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