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NCT Number: NCT03926780

Comparative Study of Oral Anticoagulation in 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.

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Key information

Conditions

Anticoagulants; Increased Left Ventricular Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Andalusia Hospitals

Alexandria, 21524, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Creatinine clearance less than 50 ml/min.

Treatment and study plan

Rivaroxaban 20 MG

Drug

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

Warfarin sodium

Drug

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

Primary outcomes

  1. Presence or absence of left ventricular thrombus as assessed by 2D transthoracic echocardiography

    Time frame: 1 month

    2D transthoracic echocardiography will be done after 1 month of initiation of the anticoagulant in order to assess the presence/absence of the thrombus

  2. Presence or absence of left ventricular thrombus as assessed by 2D transthoracic echocardiography

    Time frame: 3 months

    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. Presence or absence of left ventricular thrombus as assessed by 2D transthoracic echocardiography

    Time frame: 6 months

    2D transthoracic echocardiography will be done after 6 months of initiation of the anticoagulant in order to assess the presence/absence of the thrombus

Secondary outcomes

  1. Stroke or systemic embolism

    Time frame: Up to 6 months

    Any type of stroke or systemic embolism event will be recorded

  2. Major bleeding

    Time frame: Up to 6 months

    Any major bleeding that may occur according to the criteria of the International Society on Thrombosis and Haemostasis (ISTH) will be recorded

Sponsors and collaborators

Lead sponsor

The Young Investigator Group of Cardiovascular Research

Network

Registry information

Official study title

Comparative Study of Oral Anticoagulation in Patients With Left Ventricular Thrombi

Acronym: No-LVT

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 24, 2019
Registry last updated
Jun 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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