Comparative Study of Oral Anticoagulation in Left Ventricular Thrombi

Phase 3

Completed

• Conditions: Anticoagulants; Increased; Left Ventricular Thrombosis
• Interventions: Drug: Rivaroxaban 20 MG; Drug: Warfarin Sodium

• Registration Number: NCT03926780
• Lead Sponsor: The Young Investigator Group of Cardiovascular Research

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

Study Timeline

• Study Start: 2018-12-01
• Study First Submitted: 2019-04-21
• Study First Submitted QC: 2019-04-23
• Study First Posted: 2019-04-24
• Primary Completion: 2020-05-01
• Study Completion: 2020-05-01
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-09
• Last Update Posted: 2020-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

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

Exclusion Criteria

• Creatinine clearance less than 50 ml/min.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rivaroxaban	Rivaroxaban 20 MG	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
Warfarin	Warfarin Sodium	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)

Primary Outcome Measures

Name	Time	Method
Presence or absence of left ventricular thrombus as assessed by 2D transthoracic echocardiography	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 Outcome Measures

Name	Time	Method
Major bleeding	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
Stroke or systemic embolism	Up to 6 months	Any type of stroke or systemic embolism event will be recorded

Trial Locations

Locations (1)

Andalusia Hospitals; 🇪🇬 Alexandria, Egypt