NCT06209892

Prolonged Anticoagulation Therapy on the Prognosis of Patients With Left Ventricular Thrombosis

Prolonged Anticoagulation Therapy on the Prognosis of Patients With Left Ventricular

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A single-center, open-label, exploratory randomized controlled study is proposed with the following objectives: whether prolonging the duration of anticoagulation to 12 months, compared with 6 months of routine anticoagulation, helps to reduce major adverse cardiovascular and cerebrovascular events in patients with left ventricular thrombosis and to reduce recurrence of thrombosis, as well as to assess their bleeding risk. Patients with a definite diagnosis of left ventricular thrombus and age ≥18 years were included in cardiac ultrasound (including general ultrasound and sonography) and other examinations during hospitalization and outpatient visits. Exclusion criteria were detailed in the study protocol. GROUPING: According to the duration of anticoagulation, they were divided into extended anticoagulation group (12 months) and conventional anticoagulation group (6 months). INTERVENTION: This study is planned to extend the administration of rivaroxaban (Pulsatilla) 20 mg to 12 months in the experimental group. The conventional anticoagulation group will take the drug for 6 months Study Endpoints: The primary efficacy endpoint is a major cardiovascular-vascular adverse event at 1 year; the primary safety endpoint is bleeding of grade 3 or higher as defined by the BARC classification at 1 year. Patient Follow-up Program: Subjects will require a total of 12 on-site follow-up visits (one per month) for safety evaluation, efficacy evaluation, medication adherence evaluation, and imaging follow-up at months 3, 6, and 12.

Conditions

• Embolism and Thrombosis
• Anticoagulation

Interventions

Type	Name	Description
PROCEDURE	Extended anticoagulation	This study plan will extend the duration of rivaroxaban 20mg in the experimental group to 12 months. The regular anticoagulation group will take the drug for 6 months

Timeline

• Start date: 2024-01-01
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2024-01-18
• Last updated: 2024-01-18