Comparative Study of Oral Anticoagulation in Left Ventricular Thrombi

Study Overview
=================
Brief Summary
-----------------
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.

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

Official Title
-----------------
Comparative Study of Oral Anticoagulation in Patients With Left Ventricular Thrombi

Conditions
-----------------
Anticoagulants; Increased, Left Ventricular Thrombosis

Intervention / Treatment
-----------------
* Drug: Rivaroxaban 20 MG
* Drug: Warfarin Sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Evidence of LV thrombus as assessed by trans-thoracic echocardiography (TTE). Exclusion Criteria: Creatinine clearance less than 50 ml/min.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Warfarin<br>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<br>* 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<br>* Other names: Marevan;|
| Experimental: Rivaroxaban<br>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<br>* 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<br>* 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
warfarin, rivaroxaban, left ventricular thrombus