Comparative Study of Oral Anticoagulation in Left Ventricular Thrombi

• ClinicalTrials.gov Identifier: NCT03926780
• Recruitment Status: Recruiting
• First Posted: April 24, 2019
• Last Update Posted: April 24, 2019
• Sponsor: The Young Investigator Group of Cardiovascular Research
• Information provided by (Responsible Party): Abdallah Almaghraby, The Young Investigator Group of Cardiovascular Research

Study Description

Brief Summary:

Left ventricular (LV) thrombus is a common problem that can 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 the treatment of LV thrombus.

Condition or disease	Intervention/treatment	Phase
Anticoagulants; Increased; Left Ventricular Thrombosis	Drug: Rivaroxaban 20 MG; Drug: Warfarin Sodium	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 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 three months later.

As a secondary and safety end point, any major bleeding will be recorded.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• 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 1, 2018
• Estimated Primary Completion Date: November 1, 2019
• Estimated Study Completion Date: December 1, 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Warfarin; 30 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; 30 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 Name: Marevan
Experimental: Rivaroxaban; 30 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; 30 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 Name: Xarelto

Outcome Measures

Primary Outcome Measures :

1. Presence and dimensions 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 and its size and dimensions if still present

Secondary Outcome Measures :

1. Stroke or systemic embolism [ Time Frame: 3 months ]
   Any type of stroke or systemic embolism event will be recorded
2. Major bleeding [ Time Frame: 3 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

Contact: Abdallah M Almaghraby, MD; +201222851687; dr.maghraby@gmail.com

Contact: Mahmoud H Abdelnabi, MD; mahmoud.hassan.abdelnabi@gmail.com

Locations

Egypt

Andalusia Hospitals; Recruiting

Alexandria, Egypt, 21524

Contact: Abdallah M Almaghraby, MD +201222851687 dr.maghraby@gmail.com

Sponsors and Collaborators

The Young Investigator Group of Cardiovascular Research

Investigators

• Study Director: Haitham Badran, PhD; Assisstant Professor of Cardiology and Angiology, University of Ain Shams, Egypt

More Information

• Responsible Party: Abdallah Almaghraby, Senior Registrar of Cardiology and Angiology, The Young Investigator Group of Cardiovascular Research
• ClinicalTrials.gov Identifier: NCT03926780 History of Changes
• Other Study ID Numbers: YIG01201903
• First Posted: April 24, 2019
• Last Update Posted: April 24, 2019
• Last Verified: April 2019

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 Abdallah Almaghraby, The Young Investigator Group of Cardiovascular Research:

warfarin; rivaroxaban; left ventricular thrombus

Additional relevant MeSH terms:

Warfarin; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Rivaroxaban; Anticoagulants; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action