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

NCT ID: NCT06209892

Last Updated: 2024-01-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-31
• Study Completion Date: 2027-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional anticoagulation group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Extended anticoagulation group

Group Type: EXPERIMENTAL

Extended anticoagulation

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Weihua Song

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: RESULT

PMID: 30285032 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32273033 (View on PubMed)

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.

Reference Type: RESULT

PMID: 29029233 (View on PubMed)

Other Identifiers

BJHPA-2023-017-014

Identifier Type: -

Identifier Source: org_study_id