Clinical trial NCT04970381: An Exploratory stuDy of effectIveneSs and Safety of rivarOxaban in Patients With Left VEntricular Thrombus (R-DISSOLVE)
Official title: An Exploratory Study of Effectiveness and Safety of Rivaroxaban in Patients With Left Ventricular Thrombus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventricular Mural Thrombosis
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2021-07-21
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Patients over 18 years old;
2. 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;
3. Patients who received standard anticoagulant therapy for less than 4 weeks before enrollment did not use antiplatelet drugs or only used single antiplatelet drugs;
4. The patients voluntarily joined the study and signed the informed consent.

Exclusion Criteria:

1. Patients with contraindications to rivaroxaban anticoagulation therapy;
2. Patients with a history of acute pulmonary embolism or deep venous thrombosis within a week need intensive anticoagulant therapy;
3. Patients with history of hemorrhagic stroke within one week;
4. Patients with cardiac benign and malignant tumors;
5. Aspirin and P2Y12 receptor antagonists should be kept;
6. 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;
7. The patient's history of intracerebral hemorrhage and active hemorrhage was 8 months;
8. Patients with hematological diseases, hemoglobin \< 100g / L, platelet \< 80 x 10\^9 / L;
9. Women with pregnancy status, planned pregnancy and lactation period;
10. Patients with life expectancy less than 1 year;
11. Patients enrolled in other clinical studies;
12. 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.

Primary outcomes:
measure: Number of Participants With Left Ventricular Thrombus Resolution at 12 Weeks/Number of Participants at 12 Weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of Participants With Left Ventricular Thrombus Resolution at 6 Weeks/Number of Participants at 6 Weeks
timeFrame: 6 weeks
measure: Number of Participants With Left Ventricular Thrombus Resolution or Reduction at 6 Weeks/Number of Participants at 6 Weeks
timeFrame: 6 weeks
measure: Number of Participants With Left Ventricular Thrombus Resolution or Reduction at 12 Weeks/Number of Participants at 12 Weeks
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, Chinese Academy of Medical Sciences & Pecking Union Medical College
Study officials:
References:
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