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

Sponsor
The Young Investigator Group of Cardiovascular Research (Other)
Overall Status
Completed
CT.gov ID
NCT03926780
Collaborator
(none)
79
Enrollment
1
Location
2
Arms
17
Actual Duration (Months)
4.7
Patients Per Site Per Month

Study Details

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 Intervention/Treatment Phase
  • 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

Study Design

Study Type:
Interventional
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 :
Dec 1, 2018
Actual Primary Completion Date :
May 1, 2020
Actual Study Completion Date :
May 1, 2020

Arms and Interventions

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 Names:
  • 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 Names:
  • Xarelto

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Presence or absence of left ventricular thrombus as assessed by 2D transthoracic echocardiography [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 [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 [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 [Up to 6 months]

      Any type of stroke or systemic embolism event will be recorded

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Andalusia Hospitals Alexandria Egypt 21524

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Apr 24, 2019
    Last Update Posted:
    Jun 11, 2020
    Last Verified:
    Jun 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    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, Senior Registrar of Cardiology and Angiology, The Young Investigator Group of Cardiovascular Research
    warfarin
    rivaroxaban
    left ventricular thrombus
    Additional relevant MeSH terms:
    Thrombosis
    Warfarin
    Rivaroxaban

    Study Results

    No Results Posted as of Jun 11, 2020