An Exploratory stuDy of effectIveneSs and Safety of rivarOxaban in Patients With Left VEntricular Thrombus (R-DISSOLVE)

Study Overview
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Brief Summary
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To study the effect of rivaroxaban anticoagulant therapy for 12 weeks in patients with left ventricular mural thrombus by contrast echocardiography before and after treatment, so as to provide basis and foundation for further study and treatment selection in the future; To provide further relevant data for the treatment outcome, treatment duration and influencing factors of left ventricular mural thrombosis; It is of great sociological and health economic significance to find more effective and safe anticoagulant treatment strategies for patients with left ventricular mural thrombosis, which will reduce the incidence of embolism and bleeding.

Official Title
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An Exploratory Study of Effectiveness and Safety of Rivaroxaban in Patients With Left Ventricular Thrombus

Conditions
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Ventricular Mural Thrombosis

Intervention / Treatment
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* Drug: Rivaroxaban


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 18 years old; Patients with left ventricular thrombus newly found by body surface ultrasound less than or equal to 3 months before selection, with no limitation on basic diseases; Patients who received standard anticoagulant therapy for less than 4 weeks before enrollment did not use antiplatelet drugs or only used single antiplatelet drugs; The patients voluntarily joined the study and signed the informed consent. Exclusion Criteria: Patients with contraindications to rivaroxaban anticoagulation therapy; Patients with a history of acute pulmonary embolism or deep venous thrombosis within a week need intensive anticoagulant therapy; Patients with history of hemorrhagic stroke within one week; Patients with cardiac benign and malignant tumors; Aspirin and P2Y12 receptor antagonists should be kept; In patients with severe hepatic and renal insufficiency, alanine aminotransferase > 3 times the upper limit and total bilirubin > 2 times the upper limit, creatinine clearance rate < 15ml / min / 1.73m2; The patient's history of intracerebral hemorrhage and active hemorrhage was 8 months; Patients with hematological diseases, hemoglobin < 100g / L, platelet < 80 x 10^9 / L; Women with pregnancy status, planned pregnancy and lactation period; Patients with life expectancy less than 1 year; Patients enrolled in other clinical studies; Other situations considered unsuitable by the researcher. Note: anticoagulant therapy can be given to patients with left ventricular thrombosis combined with hemorrhagic stroke ≥ 4 weeks or recent ischemic stroke / transient ischemic attack according to the specific situation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rivaroxaban<br> | Drug: Rivaroxaban<br>* Patients with ventricular mural thrombus in the study receive rivaroxaban anticoagulant therapy for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thrombus resolution rate | The left ventricular thrombus resolution rate at 12 weeks | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thrombus resolution rate | The left ventricular thrombus resolution rate at 6 weeks | 6 weeks | 
| Thrombus resolution or reduction rate | The left ventricular thrombus resolution or reduction rate at 6 weeks | 6 weeks | 
| Thrombus resolution or reduction rate | The left ventricular thrombus resolution or reduction rate at 12 weeks | 12 weeks |