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Comparative Study of Oral Anticoagulation in Left Ventricular Thrombi (No-LVT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03926780
Recruitment Status : Completed
First Posted : April 24, 2019
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Abdallah Almaghraby, 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.


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 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 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
Actual Primary Completion Date : May 1, 2020
Actual Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Other Name: Marevan

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
Other Name: Xarelto




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



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926780


Locations
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Egypt
Andalusia Hospitals
Alexandria, Egypt, 21524
Sponsors and Collaborators
The Young Investigator Group of Cardiovascular Research
Investigators
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Study Director: Haitham Badran, PhD Assisstant Professor of Cardiology and Angiology, University of Ain Shams, Egypt
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Responsible Party: Abdallah Almaghraby, Senior Registrar of Cardiology and Angiology, The Young Investigator Group of Cardiovascular Research
ClinicalTrials.gov Identifier: NCT03926780    
Other Study ID Numbers: YIG01201903
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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