Comparative Study of Oral Anticoagulation in Left Ventricular Thrombi (No-LVT)

Comparative Study of Oral Anticoagulation in Patients With Left Ventricular Thrombi

Left ventricular (LV) thrombus is a common problem that is encountered in patients who survived from a large myocardial infarction, and distal systemic embolization is the main issue in these patients due to its major clinical consequences especially cerebrovascular stroke.

Novel oral anticoagulants (NOACs) are now used safely in nonvalvular atrial fibrillation, these agents were shown to be at least as effective as Vitamin K antagonists (VKA) such as warfarin in prevention of systemic embolism, while having an improved safety profile with less bleeding risk. However, the data about their usage for LV thrombi instead of the commonly used VKA are still lacking except for case reports and small case series.

The proposed aim of this randomized observational clinical trial is to assess the efficacy of the conventional anticoagulation in the form of warfarin and NOACs in the form of rivaroxaban in the treatment of LV thrombus.

Study Overview

• Status: Completed
• Conditions: Left Ventricular Thrombosis; Anticoagulants; Increased
• Intervention / Treatment: Drug: Warfarin Sodium; Drug: Rivaroxaban 20 MG

Detailed Description

The proposed aim of this randomized observational clinical trial is to assess the efficacy of the conventional anticoagulation in the form of warfarin and NOACs in the form of rivaroxaban in the treatment of LV thrombus.

So patients with actual LV thrombus will be divided into 2 groups, one will receive the traditional therapy which is warfarin with follow up of the INR in order to reach the desired level of 2-3 then follow up every two weeks to determine the time in therapeutic range until the end of the study follow up. The other group will receive oral rivaroxaban 20 mg per day with follow up for the persistence or the disappearance of the LV thrombus one month, three months and 6 months later.

As a secondary and safety end point, any major bleeding will be recorded as well as any thrombo-embolic events

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21524
    • Andalusia Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Evidence of LV thrombus as assessed by trans-thoracic echocardiography (TTE).

Exclusion Criteria:

• Creatinine clearance less than 50 ml/min.

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
Active Comparator: Warfarin; 38 Patients with evidence of LV thrombus as assessed by trans-thoracic echocardiography (TTE) will be assigned randomly to receive warfarin by the regular starting dose with follow up of the INR to target (2-3)	Drug: Warfarin Sodium; 38 Patients with evidence of LV thrombus as assessed by trans-thoracic echocardiography (TTE) will be assigned randomly to receive warfarin sodium by a dose starting from 3 mg per day and titrated accordingly to target an INR of 2-3; Other Names: Marevan
Experimental: Rivaroxaban; 38 Patients with evidence of LV thrombus as assessed by trans-thoracic echocardiography (TTE) will be assigned randomly to receive rivaroxaban in a dose of 20 mg per day	Drug: Rivaroxaban 20 MG; 38 Patients with evidence of LV thrombus as assessed by trans-thoracic echocardiography (TTE) will be assigned randomly to receive rivaroxaban 20 mg per day; Other Names: Xarelto

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence or absence of left ventricular thrombus as assessed by 2D transthoracic echocardiography	2D transthoracic echocardiography will be done after 1 month of initiation of the anticoagulant in order to assess the presence/absence of the thrombus	1 month
Presence or absence of left ventricular thrombus as assessed by 2D transthoracic echocardiography	2D transthoracic echocardiography will be done after 3 months of initiation of the anticoagulant in order to assess the presence/absence of the thrombus	3 months
Presence or absence of left ventricular thrombus as assessed by 2D transthoracic echocardiography	2D transthoracic echocardiography will be done after 6 months of initiation of the anticoagulant in order to assess the presence/absence of the thrombus	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke or systemic embolism	Any type of stroke or systemic embolism event will be recorded	Up to 6 months
Major bleeding	Any major bleeding that may occur according to the criteria of the International Society on Thrombosis and Haemostasis (ISTH) will be recorded	Up to 6 months

Collaborators and Investigators

• Sponsor: The Young Investigator Group of Cardiovascular Research
• Investigators: Study Director: Haitham Badran, PhD, Assisstant Professor of Cardiology and Angiology, University of Ain Shams, Egypt

Publications and helpful links

General Publications

• Abdelnabi M, Saleh Y, Fareed A, Nossikof A, Wang L, Morsi M, Eshak N, Abdelkarim O, Badran H, Almaghraby A. Comparative Study of Oral Anticoagulation in Left Ventricular Thrombi (No-LVT Trial). J Am Coll Cardiol. 2021 Mar 30;77(12):1590-1592. doi: 10.1016/j.jacc.2021.01.049. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: April 21, 2019
• First Submitted That Met QC Criteria: April 23, 2019
• First Posted (Actual): April 24, 2019

Study Record Updates

• Last Update Posted (Actual): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 9, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: warfarin; rivaroxaban; left ventricular thrombus
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Rivaroxaban; Warfarin
• Other Study ID Numbers: YIG01201903

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: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes