Apixaban in Patients With Left Ventricular Thrombus

Sponsor
Saud Al Babtain Cardiac Center (Other)
Overall Status
Completed
CT.gov ID
NCT05208398
Collaborator
(none)
50
1
2
43.4
1.2

Study Details

Study Description

Brief Summary

Open label randomized controlled clinical trial to evaluate the efficacy and safety of apixaban versus warfarin in treating left ventricular thrombus in patients with acute or recent myocardial infarction (MI).

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Open label randomized controlled clinical trial, two parallel active groups, with blinded primary study outcome assessor.Open label randomized controlled clinical trial, two parallel active groups, with blinded primary study outcome assessor.
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Apixaban in Patients With Left Ventricular Thrombus Post Myocardial Infarction; A Randomized Clinical Trial
Actual Study Start Date :
Feb 18, 2018
Actual Primary Completion Date :
Sep 30, 2021
Actual Study Completion Date :
Sep 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Apixaban

Apixaban, 5 mg oral tablets, on top of updated guidelines of acute coronary syndrome management recommendations

Drug: Apixaban
5 mg twice daily, on top of standards of care.
Other Names:
  • Eliquis
  • Active Comparator: Warfarin

    Warfarin, oral tablets, to achieve international normalized ratio (INR) of 2-3, on top of standards of care, as per updated guidelines of acute coronary syndrome management recommendations

    Drug: Warfarin
    Warfarin, oral tablets, to achieve international normalized ratio (INR) of 2-3, on top of standards of care, as per updated guidelines of acue coronary syndrome management recommendations

    Outcome Measures

    Primary Outcome Measures

    1. Resolution of left ventricular thrombus [3 months]

      Transthoracic, noncontrast, echocardiographic assessment.

    Secondary Outcome Measures

    1. Resolution of left ventricular thrombus [6 months]

      Transthoracic, noncontrast, echocardiographic assessment.

    2. Safety outcome [3-6 months]

      Major Adverse Cardiovascular Events (MACE) or any relevant bleeding according to the Bleeding Academic Research Consortium (BARC) classification

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    All the following criteria must be fulfilled:
    • Ages between 18 and 80 years,

    • History of anterior wall MI, either acute (within a week) or recent (within a month)

    • Evident left ventricular thrombus (LVT) by transthoracic echocardiography,

    • Naïve to oral anticoagulants (OAC)

    • stable to start OAC

    Exclusion Criteria:
    • Other indications for OAC,

    • Patients with contraindications for OAC,

    • Right ventricular thrombus or atrial thrombus,

    • History of confirmed stroke or other systemic embolization within the previous six months,

    • High bleeding risk,

    • Severe renal impairment,

    • Patients with expected difficulties to follow the INR strictly.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Saud AlBabtain Cardiac Center Dammam Saudi Arabia

    Sponsors and Collaborators

    • Saud Al Babtain Cardiac Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Saud Al Babtain Cardiac Center
    ClinicalTrials.gov Identifier:
    NCT05208398
    Other Study ID Numbers:
    • IRB-2018-08
    First Posted:
    Jan 26, 2022
    Last Update Posted:
    Jan 26, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 26, 2022