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

Prolonged Anticoagulation Therapy on the Prognosis of Patients With Left Ventricular

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Embolism and Thrombosis; Anticoagulation
• Intervention / Treatment: Procedure: Extended anticoagulation

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

①Patients who have been clearly diagnosed with left ventricular thrombus by inpatient or outpatient cardiac ultrasound (including general ultrasound and acoustic imaging).

②Age >= 18 years old

Exclusion Criteria:

• Patients do not agree to participate in the study or have poor compliance in the past

  • Contraindication to anticoagulation or allergy to anticoagulants ③Have received oral anticoagulation after diagnosis of left ventricular thrombus.

    • Have undergone or are planning to undergo surgical procedures including left ventricular appendage thrombectomy, heart transplantation, ventricular wall tumor collapse, or valve replacement.

      • Presence of other long-term indications for anticoagulation, such as mechanical valve implantation, atrial fibrillation, etc.

        • Requirement for treatment with Tegretol and inability to change to clopidogrel bisulfate ⑦Presence of known malignant tumors, severe hepatic dysfunction (Child-Pugh classification B or less), severe renal dysfunction (creatinine clearance <30ml/min), anemia (Hb <100g/L), coagulation disorders and other underlying diseases, or life expectancy <3 years ⑧ Female patients are pregnant or breastfeeding ⑨ Patients with antiphospholipid syndrome

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Conventional anticoagulation group
Experimental: Extended anticoagulation group	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary efficacy endpoint	for major cardiovascular and cerebrovascular adverse events at 1 year, including: all-cause mortality, nonfatal heart attack, ischemic stroke, and acute peripheral artery embolism. fatal heart attack, ischemic stroke, and acute peripheral artery embolism	Patient completes one year of follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
secondary endpoint	Dissolution of left ventricular thrombus confirmed by cardiac ultrasound and no recurrence detected and/or recurrence of left ventricular thrombus detected by cardiac ultrasound after dissolution of left ventricular thrombus	Patient during one year of follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary safety endpoint	Bleeding of grade 3 or higher as defined by the BARC classification at 1 year	Patient during one year of follow-up

Collaborators and Investigators

• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Publications and helpful links

General Publications

• Bulluck H, Vincent M, Hausenloy DJ. Optimizing the Detection of Left Ventricular Thrombus Following Acute Myocardial Infarction in the Current Era. JAMA Cardiol. 2018 Nov 1;3(11):1128-1129. doi: 10.1001/jamacardio.2018.3136. No abstract available.
• Maniwa N, Fujino M, Nakai M, Nishimura K, Miyamoto Y, Kataoka Y, Asaumi Y, Tahara Y, Nakanishi M, Anzai T, Kusano K, Akasaka T, Goto Y, Noguchi T, Yasuda S. Anticoagulation combined with antiplatelet therapy in patients with left ventricular thrombus after first acute myocardial infarction. Eur Heart J. 2018 Jan 14;39(3):201-208. doi: 10.1093/eurheartj/ehx551.
• Lattuca B, Bouziri N, Kerneis M, Portal JJ, Zhou J, Hauguel-Moreau M, Mameri A, Zeitouni M, Guedeney P, Hammoudi N, Isnard R, Pousset F, Collet JP, Vicaut E, Montalescot G, Silvain J; ACTION Study Group. Antithrombotic Therapy for Patients With Left Ventricular Mural Thrombus. J Am Coll Cardiol. 2020 Apr 14;75(14):1676-1685. doi: 10.1016/j.jacc.2020.01.057.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 6, 2024
• First Submitted That Met QC Criteria: January 6, 2024
• First Posted (Estimated): January 18, 2024

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 6, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism; Thrombosis; Embolism and Thrombosis
• Other Study ID Numbers: BJHPA-2023-017-014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No