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

Anticoagulation Clinical Trial

Official title:

Prolonged Anticoagulation Therapy on the Prognosis of Patients With Left Ventricular

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06209892
• Other study ID #: BJHPA-2023-017-014
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: December 2027

Study information

• Verified date: January 2024
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 220
• Est. completion date: December 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

?Age >= 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 ?Have 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 ?Presence 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 ? Female patients are pregnant or breastfeeding ? Patients with antiphospholipid syndrome

Related Conditions & MeSH terms

• Anticoagulation
• Embolism
• Embolism and Thrombosis
• Thrombosis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

References & Publications (3)

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. — View Citation

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 Ventr — View Citation

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 afte — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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