Comparative Study of Oral Anticoagulation in Left Ventricular Thrombi
Clinicaltrials.gov identifier recruitment status First Posted Last update posted
NCT03926780 Completed April 24, 2019 June 11, 2020

study description
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.

Condition or Disease: Anticoagulants; Increased
Left Ventricular Thrombosis
Intervention/treatment: Drug: Rivaroxaban 20 MG
Drug: Warfarin Sodium
Phase: Phase 3
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 design
Study Type: Interventional
Estimated Enrollment : 79 participants
Intervention Model : Parallel Assignment
Masking: None (Open Label) ()
Primary Purpose: Treatment
Official Title: Comparative Study of Oral Anticoagulation in Patients With Left Ventricular Thrombi
Actual Study Start Date: December 2018
Actual Primary Completion Date: May 2020
Actual Study Completion Date: May 2020

Arms and interventions
Arm Intervention/treatment
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
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
outcome measures
Primary Outcome Measures: 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 Outcome Measures: 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

Eligibility Criteria
Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- Creatinine clearance less than 50 ml/min.


Contacts and Locations
Contacts
Locations
Egypt Andalusia Hospitals Alexandria
Sponsors and Collaborators
The Young Investigator Group of Cardiovascular Research
Investigator
Study Director : Haitham Badran, PhD Assisstant Professor of Cardiology and Angiology, University of Ain Shams, Egypt
More Information
Responsible Party : The Young Investigator Group of Cardiovascular Research
ClinicalTrials.gov Identifier : NCT03926780     
Other Study ID Numbers : YIG01201903
First Posted : April 24, 2019
Last Update Posted : June 11, 2020
Last Verified : June 2020
Individual Participant
Data (IPD) Sharing
Statement:
 
Plan to Share IPD: No
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
Keywords provided by The Young Investigator Group of Cardiovascular Research: rivaroxaban
warfarin
left ventricular thrombus
Additional relevant MeSH terms :
Thrombosis