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

Not Applicable

Completed

• Conditions: Ventricular Mural Thrombosis
• Interventions: Drug: Rivaroxaban

• Registration Number: NCT04970381
• Lead Sponsor: China National Center for Cardiovascular Diseases

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-27
• Study First Submitted: 2021-07-11
• Study First Submitted QC: 2021-07-11
• Study First Posted: 2021-07-21
• Primary Completion: 2022-10-30
• Study Completion: 2022-10-30
• Results First Submitted: 2023-03-12
• Status Verified: 2024-02
• Results First Submitted QC: 2024-02-21
• Last Update Submitted: 2024-02-21
• Results First Posted: 2024-08-02
• Last Update Posted: 2024-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rivaroxaban	Rivaroxaban	Rivaroxaban: Patients with ventricular mural thrombus in the study receive rivaroxaban anticoagulant therapy for 12 weeks. The dosage of rivaroxaban was typically 20mg once daily, or 15mg once daily if patients were on dual antiplateletagents, or with creatinine clearance of 30-50mL/min.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Left Ventricular Thrombus Resolution at 12 Weeks/Number of Participants at 12 Weeks	12 weeks	the rate of left ventricular thrombus resolution at 12 weeks=Number of Participants with left ventricular thrombus resolution at 12 weeks/Number of Participants at 12 weeks

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Left Ventricular Thrombus Resolution or Reduction at 6 Weeks/Number of Participants at 6 Weeks	6 weeks	The left ventricular thrombus resolution or reduction rate at 6 weeks=Number of Participants With Left Ventricular Thrombus Resolution or reduction at 6 Weeks/Number of Participants at 6 Weeks
Number of Participants With Left Ventricular Thrombus Resolution at 6 Weeks/Number of Participants at 6 Weeks	6 weeks	The left ventricular thrombus resolution rate at 6 weeks=Number of Participants With Left Ventricular Thrombus Resolution at 6 Weeks/Number of Participants at 6 Weeks
Number of Participants With Left Ventricular Thrombus Resolution or Reduction at 12 Weeks/Number of Participants at 12 Weeks	12 weeks	The left ventricular thrombus resolution or reduction rate at 12 weeks=Number of Participants With Left Ventricular Thrombus Resolution or reduction at 12 Weeks/Number of Participants at 12 Weeks

Trial Locations

Locations (1)

Fuwai Hospital, Chinese Academy of Medical Sciences & Pecking Union Medical College; 🇨🇳 Beijing, China